Tuesday, December 22, 2020

Vatican: OK to Get Virus Vaccines Using Abortion Cell Lines + More

 

10/30/20

Vatican: OK to Get Virus Vaccines Using Abortion Cell Lines + More

The Defender’s COVID NewsWatch brings you the latest headlines on COVID-19 and vaccines.

December 22, 2020

Vatican: OK to Get Virus Vaccines Using Abortion Cell Lines. ABC News reported:

“The Vatican didn’t name any of the COVID-19 vaccines already being given to people in some countries or authorized to be used soon.

“In its statement, the Vatican explained that obtaining vaccines that do not pose an ethical dilemma is not always possible. It cited circumstances in countries “where vaccines without ethical problems are not made available to physicians and patients” or where special storage or transport conditions make their distribution more difficult.”

Bill Gates-Led Effort to Get $3.36 Billion Into the Coronavirus Deal to Help Vaccinate World’s Poor. Yahoo!News reported:

“As part of the announcement Sunday evening of a $900 billion coronavirus relief deal, House Speaker Nancy Pelosi and Senate Minority Leader Chuck Schumer touted ‘an additional $3.36 billion for a total of $4 billion for GAVI, the international vaccine alliance.’

“The Democratic leaders said the money recognizes that ‘we are not truly safe until the whole world is safe from the coronavirus.’

“Gavi, a public-private health partnership, and a similar organization called the Global Fund have ‘spent two decades becoming experts in the task of financing vaccines, drugs, and diagnostics,’ Gates recently wrote.”

Fauci Tells Kids Not to Worry, He Gave Santa Claus the COVID-19 vaccine. NBC News reported:

“Fauci assured good children that he wouldn’t let them be disappointed after making the nice list in a very tough year. The coronavirus expert anticipated Santa’s essential worker status and took matters into his own hands.

“‘I took a trip up there to the North Pole,’ Fauci said. ‘I went there and I vaccinated Santa Claus myself. I measured his level of immunity, and he is good to go. … Santa Claus is good to go.’”

Suspicions Grow That Nanoparticles in Pfizer’s COVID-19 Vaccine Trigger Rare Allergic Reactions. Science reported:

Severe allergy-like reactions in at least eight people who received the COVID-19 vaccine produced by Pfizer and BioNTech over the past 2 weeks may be due to a compound in the packaging of the messenger RNA (mRNA) that forms the vaccine’s main ingredient, scientists say. A similar mRNA vaccine developed by Moderna, which was authorized for emergency use in the United States on Friday, also contains the compound, polyethylene glycol (PEG).

“PEG has never been used before in an approved vaccine, but it is found in many drugs that have occasionally triggered anaphylaxis — a potentially life-threatening reaction that can cause rashes, a plummeting blood pressure, shortness of breath, and a fast heartbeat. Some allergists and immunologists believe a small number of people previously exposed to PEG may have high levels of antibodies against PEG, putting them at risk of an anaphylactic reaction to the vaccine.”

Pfizer and Moderna Are Testing Their Vaccines Against UK Coronavirus Variant. CNN reported:

Pfizer and Moderna are testing their coronavirus vaccines to see if they work against the mutated version of the virus found in the United Kingdom and other countries, the companies said.

“‘The variant has not been identified in the United States, the U.S. Centers for Disease Control and Prevention said in a Tuesday brief, but “’given the small fraction of U.S. infections that have been sequenced, the variant could already be in the United States without having been detected.’”

Growing Number of Lawmakers Decline Early Access to COVID-19 Vaccine. The Hill reported:

A handful of lawmakers in both parties, including Reps. Brian Mast (R-Fla.), Ilhan Omar (D-Minn.), Tulsi Gabbard (D-Hawaii), Jefferson Van Drew (R-N.J.), Sen. Rand Paul (R-Ky.) and incoming Rep.-elect Nancy Mace (R-S.C.), all made a point of announcing they would refuse a vaccine before all front-line health care workers and seniors get inoculated.

“Most other lawmakers are getting their first of two doses of the vaccine and urging others to follow suit, arguing it’s necessary to ensure continuity of government in the pandemic.”

Biden Receives First Dose of COVID-19 Vaccine on Live Television. CNN reported:

“Biden said the Trump administration deserved some credit for Operation Warp Speed, the federal government’s vaccine program, and their role in making coronavirus vaccinations possible.

“’I also think that it’s worth saying that this is, is great hope. I’m doing this to demonstrate that people should be prepared, when it’s available, to take the vaccine. There’s nothing to worry about. I’m looking forward to the second shot; so is Jill,’ Biden said.”

Confusion Reigns as Companies, Industries Try to Navigate U.S. COVID-19 Vaccine Rollout. Reuters reported:

“The lack of coordinated plans has led dozens of industry groups and individual companies, including Amazon.com Inc and Uber Technologies Inc, to lobby state and federal officials to move their workers closer to the front of the line.

“Several states including New York, Massachusetts and Michigan do not follow the panel’s recommendations and have instead drafted their own list of essential workers to be prioritized for a vaccine. Some also prioritize people with pre-existing medical conditions, who were not accounted for by the advisory panel.”

***

December 21, 2020

When the Elderly and Frail Die after Receiving the COVID Vaccine. Global Research reported:

“’Since they [the COVID vaccines] haven’t been studied in people in those [elderly] populations, we don’t know how well the vaccine will work for them. We know that most vaccines don’t work nearly as well in a frail elderly person as they would in someone who is fit and vigorous, even if they happen to be the same age,’ Moore said.’

“Again — zero evidence the COVID vaccines work in elderly and frail populations. Most vaccines don’t ‘work nearly as well.’

“CNN: ‘When shots begin to go into arms of [nursing home and long-term care facility] residents, Moore said Americans need to understand that deaths may occur that won’t necessarily have anything to do with the vaccine.’”

FDA Investigates Allergic Reactions to Pfizer COVID Vaccine After More Healthcare Workers Hospitalized. Children’s Health Defense reported:

The U.S. Food and Drug Administration (FDA) told reporters late Friday the agency is  investigating “about five” allergic reactions to the Pfizer COVID-19 vaccine in “multiple states. 

“The announcement followed Friday’s news that an Illinois hospital temporarily shut down its COVID vaccination program after four healthcare workers there experienced allergic reactions — one of which was severe — to the vaccine.

“Also on Friday, CNN reported that a third healthcare worker in Alaska was hospitalized for six hours for an anaphylactic reaction to the Pfizer vaccine. The report came on the heels of last week’s news that two Alaskan healthcare workers had severe allergic reactions — including one woman who was hospitalized for at least two nights after going into anaphylactic shock.”

Employers Can Require Workers to Get Covid-19 Vaccine, U.S. Says. New York Times reported:

“Employers can require workers to get a COVID-19 vaccine and bar them from the workplace if they refuse, the federal government said in guidelines issued this week.

“Public health experts see employers as playing an important role in vaccinating enough people to reach herd immunity and get a handle on a pandemic that has killed more than 300,000 Americans.”

EU Regulators Recommend Pfizer/BioNTech’s Covid-19 Vaccine for Authorization. CNN reported:

“The European Union drugs regulator has recommended authorizing the Pfizer/BioNTech COVID-19 vaccine for use, paving the way for the first phase of the bloc’s mass vaccination program to begin later this week.

“In a closed-door meeting in Amsterdam on Monday, the European Medicines Agency (EMA) granted the Pfizer/BioNTech vaccine a conditional marketing authorization, green lighting the drug for distribution.

“Before the 27-nation bloc can begin its rollout, the European Commission must give its final approval, which European Commission President Ursula von der Leyen would likely happen later on Monday.”

Police, Firefighters, Teachers Will Be Next in Line for COVID-19 Vaccine. USA Today reported:

“Police, firefighters, teachers and grocery workers will be among those next in line for a COVID-19 vaccine, a Centers for Disease Control and Prevention advisory panel decided Sunday.

“The committee voted 13-1 to recommend that Phase 1b include people 75 and older and front-line essential workers. Phase 1c will include people 65 to 74 and people 16 to 64 who have high-risk medical conditions, along with other essential workers.”

Nursing Homes Face Daunting Task of Getting Consent Before They Give Coronavirus Vaccines. Washington Post reported:

“More than 3 million elderly and infirm residents of nursing homes and other long-term-care facilities may face delays in getting coronavirus vaccines as the facilities confront the difficult task of obtaining consent, which consumer advocates, operators and some health officials say should have been simplified and started earlier by the federal government.

“Obtaining consent presents one of the toughest hurdles as officials mobilize to inoculate residents of these facilities, many of whom have dementia or Alzheimer’s disease.”

Locals Hesitant About COVID-19 Vaccine as CDC Releases Next Group Recommendation. NBC News reported:

“’We’ve been trying to find a cure for cancer and all the other diseases out there so it’s just kind of bothersome to know that they were so quick to find a vaccine for COVID but nothing else so I’m just going to wait,’ said Gina Jimez from Perrysburg who said she will not get the vaccine any time soon.

“’I mean they came out with a drug in six months, it just hasn’t been tested that long enough to see what’s going to be the real results of it, we don’t know the long-term effects on it, we don’t know what’s going to happen the ups and downs and how people are going to react to it,’ said Nick Sarno from Perrysburg who said he will not get the vaccine.”

Russian Scientist Working on COVID-19 Vaccine Plummets to Death in St. Petersburg. New York Post reported:

“Kagansky, best known for his work on cancer research, was an assistant professor in Vladivostok and had spent 13 years working in Edinburgh, Scotland, until 2017, the outlet said.

“He was most recently working as director of the Center for Genomic and Regenerative Medicine at Russia’s Far Eastern Federal University. He had been working on developing a vaccine against the coronavirus, e2news said.”

‘I failed’: Operation Warp Speed Leader Takes Responsibility for COVID-19 vaccine distribution confusion. STAT reported:

“The striking mea culpa — rare among U.S. officials in the response to the COVID-19 pandemic — came during a briefing in which Perna, the chief operating officer of OWS, said repeatedly that he had underestimated the time required to get the vaccine doses approved for distribution to states. The chaos over allotments followed labeling confusion that caused hospital pharmacists at several health systems to throw away one in every six doses of the first vaccines distributed.”

Chinese and Russian Vaccines Remain Unproven — But Desperate Countries Plan to Use Them Anyway. Washington Post reported:

“Cambodian Prime Minister Hun Sen said Tuesday that his country is not ordering a vaccine candidate developed by the Chinese biotech firm Sinovac because it has not been certified by a global body. “Cambodia is not a dustbin . . . and is not a place for a vaccine trial,” he said.

“But the questions over China’s and Russia’s candidates have not stopped other countries from moving forward with deals, approvals and vaccinations”

***

December 18, 2020

FDA Panel Endorses Moderna’s Covid-19 Vaccine. New York Times reported:

Moderna would be the second company allowed to begin inoculating the public, giving millions more Americans access to desperately needed vaccine. The first, made by Pfizer and its German partner BioNTech, received authorization last week.

“The Moderna vaccine can be distributed more widely because it can be stored at normal freezer temperatures and, unlike the Pfizer-BioNTech vaccine, does not require ultracold storage. It also comes in much smaller batches, making it easier for hospitals in less populated areas to use quickly.”

Pregnant Women Should Be Offered COVID-19 Vaccine, Experts Agree. Medscape reported:

COVID-19 vaccines should not be withheld from people who are pregnant or lactating and want to be vaccinated, despite a lack of safety data in these populations, according to guidance from the Centers for Disease Control and Prevention (CDC), the American College of Obstetricians and Gynecologists (ACOG), and the Society for Maternal-Fetal Medicine.

“Pregnant women who opt not to receive the vaccine should be supported in that decision as well, a practice advisory from ACOG recommends.

“’Pregnant women who experience fever following vaccination should be counseled to take acetaminophen,’ the advisory notes.”

The Wealthy Scramble for COVID-19 Vaccines: ‘If I donate $25,000 … Would That Help Me?’ The LA Times reported:

“‘We get hundreds of calls every single day,’ said Dr. Ehsan Ali, who runs Beverly Hills Concierge Doctor. His clients, who include Ariana Grande and Justin Bieber, pay between $2,000 and $10,000 a year for personalized care. ‘This is the first time where I have not been able to get something for my patients.’

“With the first doses in short supply, California has laid out a strict order of vaccinations based on need and risk: Healthcare workers and nursing home residents, then essential workers and those with chronic health conditions, then, finally, everyone else.”

States Report Confusion as Government Reduces Vaccine Shipments, While Pfizer Says It Has ‘Millions’ of Unclaimed Doses. Washington Post reported:

“The clashing accounts came as Pfizer and the Trump administration negotiate over additional vaccine doses for the United States. Pfizer, which has already committed to providing the government 100 million doses, said that as recently as October, federal officials had turned down its entreaties to lock in another 100 million doses. When those officials sought to buy those doses later, the company said its supplies were already committed to other countries. Now the pharmaceutical giant and the administration are nearing an agreement that would provide the United States with more than 50 million doses, but fewer than 100 million, probably spread over the second and third quarters of 2021, according to people knowledgeable about the negotiations who spoke on the condition of anonymity.”

Europe Is Paying Less Than U.S. for Many Coronavirus Vaccines. Washington Post reported:

“Comparing that list to calculations by Bernstein Research, an analysis and investment firm, it appears the 27-nation union has a 24 percent discount on the Pfizer vaccine compared to the United States, paying $14.76 per dose compared to $19.50 in the United States. Some of the difference may reflect that the E.U. subsidized that vaccine’s development.

“The bloc will pay 45 percent less than the United States for the AstraZeneca-Oxford vaccine currently under development. But it will pay 20 percent more than the United States for the Moderna vaccine, which is expected to be approved for U.S. use on Friday.”

COVID-19 Vaccine Starts Rolling Out to Members of Congress. ABC News reported:

“The legislative branch of government is rapidly moving to receive the coronavirus vaccine, with top leaders of the U.S. House and Senate getting the shots this week and the top Capitol doctor urging all members of Congress to join them.

“The Capitol physician, Dr. Brian P. Monahan, informed members that they are all eligible for the shots under government continuity guidelines. He asked all members to make appointments with his office to be vaccinated.”

Is COVID-19 Really Improving Pharma’s Reputation? Takeda Survey Says Not so Much. FiercePharma reported:

“Thinking pharma might earn a halo with its COVID-19 work? Not so fast, Takeda says. Its recent U.K. study finds only an incremental boost in positive consumer sentiment.

“Only 17% of adults surveyed in October agreed that their perception of the pharma industry has improved during the pandemic, while the majority (54%) said their opinion hasn’t changed. Ipsos MORI fielded the study with adults in the U.K. and also with healthcare professionals.”

Do we need a COVID-19 vaccine for pets? Science reported:

“SARS-CoV-2 has never been an exclusively human problem. Since the early days of the pandemic, scientists have been concerned about the impact of the virus responsible for COVID-19 on pets, livestock, and wildlife. Cats and dogs can become infected, and cats appear to transmit the coronavirus to other cats, at least in the lab. Minks at hundreds of farms around the globe have suffered outbreaks, leading to massive culling, and in some cases, human infections. And scientists worry people or domestic animals could transmit the virus to wildlife, creating an uncontrollable reservoir of the disease.”

***

December 17, 2020

You Can’t Sue Pfizer or Moderna if You Have Severe COVID Vaccine Side Effects. The Government Likely Won’t Compensate You for Damages Either. CNBC reported:

“The federal government has granted companies like Pfizer and Moderna immunity from liability if something unintentionally goes wrong with their vaccines.

“‘It is very rare for a blanket immunity law to be passed,’ said Rogge Dunn, a Dallas labor and employment attorney. ‘Pharmaceutical companies typically aren’t offered much liability protection under the law.’

“You also can’t sue the Food and Drug Administration for authorizing a vaccine for emergency use, nor can you hold your employer accountable if they mandate inoculation as a condition of employment.”

2 Alaska Healthcare Workers Suffer Allergic Reaction to Pfizer COVID Vaccine. How Many More Are at Risk? CHD reported:

“Two days after the first COVID-19 vaccine was administered in the U.S. — to a healthcare worker in Long Island, New York — two healthcare workers in Alaska who received Pfizer’s COVID vaccine experienced allergic reactions. One of those, a woman with no prior history of allergies, suffered an anaphylactic reaction and spent at least two nights in the hospital.”

Pfizer Facing ‘Various Challenges’ in COVID-19 Vaccine Manufacturing, Dosing: Feds. Fierce Pharma reported:

“Why did healthcare workers in California and Alabama have to return trays of Pfizer’s COVID-19 vaccine after discovering they were stored at temperatures that were colder than recommended? Does each vial of the vaccine contain more than the expected five doses, and if so, can those be used to meet the high demand for the shot?

“Those were some of the questions U.S. government officials addressed yesterday. Operation Warp Speed co-leader Gen. Gustave Perna kicked off a press conference citing “an excellent collaboration” between the government and Pfizer, but when asked for additional details, he and other leaders of Operation Warp Speed hinted that the effort to speed the vaccine to vulnerable populations may not be going as smoothly as advertised.”

Major CEOs Signal COVID Vaccine Mandates Could Be on the Way. CNN reported:

“Some business leaders are in favor of requiring their employees take COVID-19 vaccines.

“Seventy-two percent of current and recent CEOs of major companies signaled an openness to vaccine mandates, according to a poll held Tuesday at a virtual summit by the Yale Chief Executive Leadership Institute.”

Pharmacies Will Help Roll Out the Coronavirus Vaccine but one Doctor Warns of ‘Chaos’ CBS News reported:

“After striking deals with the federal government, pharmacies like CVS and Walgreens will help administer the coronavirus vaccine — first to health care workers, long-term care residents and staff and eventually to the general public. Walmart and Sam’s Club are also preparing their pharmacies for the rollout.

“The first doses left Pfizer’s Michigan plant Sunday.

“There are  discrepancies, however, about when the first dose will be given to nursing home residents, who are some of the most vulnerable to the virus.”

Did the FDA Understaff Its Review of the Pfizer/Biontech Vaccine? Stat News reported:

“In what is arguably the most important decision the Food and Drug Administration has made this year — its emergency use authorization of the Pfizer/BioNTech COVID-19 vaccine — the agency apparently assigned only a single reviewer in each of two key scientific disciplines (clinical and statistics) to do the work in three weeks that usually takes months to do.

“The FDA’s authorization last week followed similar authorizations in the United Kingdom and Canada. But the FDA’s decision is particularly important because of its reputation for being the international “gold standard” in regulatory rigor.”

At Houston Hospital, Head of COVID-19 Unit Sees Some Staff Wary of a Vaccine. NPR reported:

“Varon said that starting next week doctors and nurses at the hospital will begin receiving doses of the recently authorized Pfizer vaccine. Hospital staff, he said, were ‘very happy’ learning this news.

“Still, despite clinical trials showing the vaccine to be 95% effective, Varon said that some of the nurses on his unit tell him they’re not planning on getting vaccinated.”

Moderna Stock Dives As Fauci Questions Durability of COVID Vaccines. Investor’s Business Daily reported:

Moderna stock tumbled Tuesday after Dr. Anthony Fauci reiterated it’s unknown how long immunity from coronavirus vaccines might last.

“Fauci heads up the National Institute of Allergic and Infectious Diseases, which was involved in the testing of Moderna‘s (MRNA) vaccine. Fauci’s commentary came the same day the Food and Drug Administration said data from Moderna’s clinical test of its COVID-19 vaccine ‘met the pre-specified success criteria.’”

Rite Aid Partners With CDC on COVID-19 Vaccine as Profits Soar. Fox Business reported:

Rite Aid Corp. is partnering with the Centers for Disease Control and Prevention in helping administer COVID-19 vaccines.

“’We have administered over one million COVID-19 tests and will be partnering with the CDC to help administer COVID-19 vaccines in our communities,’ Rite Aid CEO Heyward Donigan said in a statement alongside the company’s quarterly results.”

***

December 16, 2020

Why Might Women Be Less Eager to Get the Coronavirus Vaccine? An Investigation. Washington Post reported:

“It was also possible that some women were following medical guidance, not from online anti-vaxxers but actual medical caregivers. Pregnant and lactating women were excluded from Pfizer and Moderna’s coronavirus vaccine trials, as they are from many clinical trials (a few dozen participants inadvertently became pregnant during the course of the studies). This means the existing safety assurances might not feel as reassuring to the subset of women who fear not only for their own health but also for their babies.’”

COVID Is Having a Devastating Impact on Children — and the Vaccine Won’t Fix Everything. NBC News reported:

“It has been almost 10 months since COVID-19 began battering families in the United States, putting parents out of work, shrouding their homes in grief and loss, and shutting children out of the schools that taught and cared for them.

“It’s all taken an unthinkable toll on children — a social, emotional and academic ordeal so extreme that some advocates and experts warn its repercussions could rival those of a hurricane or other disaster.”

COVID-19 Vaccine Trial Volunteers Note Occasional Harsh Side Effects. Wall Street Journal reported:

“‘I woke up around midnight freezing,’ said the 68-year-old retired nurse. ‘For the next 24 hours I had intense chills, serious neck pain, headache, all my joints were aching.’ She had a fever that peaked at 102.4 and poured out so much sweat that she lost 3 pounds, she said. The following day she woke up and felt fine.

“Ms. Edwards, like the other 30,000 volunteers who took part in Phase 3 clinical trials for Moderna’s COVID-19 vaccine, wasn’t told whether she got the vaccine or a placebo. However, she said a trial researcher attributed her symptoms to her body mounting a strong immune response to what was most likely the vaccine. ‘It’s better having 36 hours of feeling really rough than getting COVID,’ she said.”

FDA Authorizes First Fully At-Home Test as More COVID-19 Patients Are Hospitalized than Ever Before. CNN reported:

“The US Food and Drug Administration gave emergency authorization Tuesday for the first COVID-19 test that can be fully taken at home.

Other at-home tests require a prescription or require people to send test samples to a lab to get results. But the COVID-19 home test developed by Australian company Ellume is sold over-the-counter and produces results that can be read at home.”

COVID-19 Nasal Spray From Eureka Therapeutics Protects Mice Against Infection. Fierce Pharma reported:

“A single administration of Eureka’s drug into the nose protected mice against SARS-CoV-2 pseudovirus for at least 10 hours, even at the lowest concentrations tested, researchers from the company described in a paper on the preprint site bioRxiv.

“The Bay Area biotech figures the nasal spray, now called InvisiMask, could work as a daily preventive measure against COVID-19, and it’s preparing a clinical trial application with the FDA.”

WHO Sees ‘Strong Commitment’ From Pfizer on Affordable COVID Vaccine. Reuters reported:

“A World Health Organization senior official said on Tuesday that the agency was in talks with Pfizer to include its COVID-19 vaccine as part of an early global roll out.

“Bruce Aylward, WHO senior adviser, said that he saw a ‘strong commitment’ on the part of its CEO Albert Bourla to set prices at levels appropriate to poorer populations. He expected some news on more manufacturers joining the list of providers to the COVAX vaccine facility in coming weeks, he added.”

***

December 15, 2020

FDA Staff Recommends Watching for Bell’s Palsy in Moderna and Pfizer Vaccine Recipients. CNBC reported:

“U.S. Food and Drug Administration staff recommends monitoring people who get Pfizer or Moderna’s COVID-19 vaccine shots for possible cases of Bell’s palsy, saying it’s not necessarily a side effect but worth watching out for after a handful of trial participants got the condition, which causes half of your face to droop.”

Moderna’s COVID-19 Vaccine Clears First U.S. FDA Hurdle. Al Jazeera reported:

“Moderna’s COVID-19 vaccine appeared to be set for regulatory authorisation this week after US Food and Drug Administration (FDA) staff members did not raise any major new concerns about it in documents released on Tuesday.

“The FDA reviewers said a two-dose regimen of Moderna’s vaccine was highly effective in preventing confirmed cases of COVID-19 and did not raise any specific safety issues with using the vaccine in adults over the age of 18.”

Should Pregnant People Take the Vaccine? FDA and CDC Say That’s Up to Them. Intelligencer reported:

“Over the weekend, after initial fears that pregnant and lactating health-care workers would be barred from receiving the COVID-19 vaccine because of a lack of safety data from clinical trials, the FDA and the CDC instead left the door open for them to choose. What comes next will fall on the institutions distributing the vaccines, and the individual health-care worker having to decide as early as next week whether to get that shot, based on limited information.

Survey Shows Generational Vaccine Attitudes. Medical Economics reported:

“The majority of the three younger reporting groups (56 percent of Gen Z, 57 percent of Millennials, and 60 percent of Gen X) are concerned about getting the flu and COVID-19 at the same time. Meanwhile less than half of the respondents younger than 65 received their flu shot previous to the survey compared to 70 percent among those over 65, the release says.

“More than a quarter of the younger respondents say that they do not plan to receive the flu shot this year, while a majority of those who had not received the shot (68 percent of Gen Z, 80 percent of Millennials, and 78 percent of Gen X) say that they usually do not receive a flu shot, according to the release.”

With Pfizer Shot Spoken for, U.S. Snaps Up 100M More Moderna COVID-19 Vaccine Doses. Fierce Pharma reported:

“The U.S. government on Friday tapped its option to buy additional doses of Moderna’s COVID-19 vaccine candidate, mRNA-1273, snapping up 100 million more doses for around $1.68 billion. The deal raises the U.S. order to 200 million doses, enough to vaccinate 100 million people. The shot is up for review at an FDA advisory panel meeting Thursday.

“The latest slate of Moderna shots are set for delivery in the second quarter of 2021. Ahead of that, Moderna plans to ship out some 20 million doses this month and deliver 80 million more in the first quarter, the company said—provided it wins an emergency FDA authorization as expected.”

Trump Scraps Plan to Have Top White House Personnel Among First Vaccinated Against COVID-19. CBS News reported:

“President Trump said Sunday he was reversing an administration directive to vaccinate top government officials against COVID-19, while public distribution of the shot is limited to frontline health workers and people in nursing homes and long-term care facilities. Mr. Trump made the announcement hours after his administration confirmed that senior U.S. officials, including some White House aides who work in close proximity to Mr. Trump and Vice President Pence, would be offered coronavirus vaccines as soon as this week under federal continuity of government plans.”

Report: Cornell University Makes Flu Vaccination Mandatory – But Only for White Students. Law Enforcement Today reported:

“An Ivy League university is requiring that white students receive an annual flu vaccination, while providing an exemption for students belonging to any other race.

“Because of ‘historical injustices and current events,’ Cornell University will grant  to ‘people of color’ an exemption from its requirement that all students get a flu vaccination.”

A Century After 1918 Pandemic Killed 675,000 Americans, U.S. Remains a Country Divided Over a COVID-19 Vaccine. New York Daily News reported:

“An Associated Press-NORC Center for Public Affairs Research poll illustrated the stark vaccine schism among Americans, even as the pandemic’s second wave wreaks continued havoc across the country.

“According to the poll, roughly one in four Americans say they will not get vaccinated. And another one in four say they remain unsure if they will or won’t get inoculated when the vaccine is made available via the largest vaccination program in U.S. history.”

Why a COVID-19 Vaccine Doesn’t Mean You Can Stop Wearing a Mask. CNN reported:

“Here’s what the studies don’t yet show. They haven’t looked at whether the vaccine prevents someone from carrying COVID-19 and spreading it to others. It’s possible that someone could get the vaccine but could still be an asymptomatic carrier. They may not show symptoms, but they have the virus in their nasal passageway so that if they’re speaking, breathing, sneezing and so on, they can still transmit it to others.”

***

December 14, 2020

COVID-19: First Vaccine Given in U.S. as Rollout Begins. BBC reported:

“An intensive care nurse in Long Island, New York is believed to have been the first person to be given the jab.

“Millions of vials of the Pfizer/BioNTech vaccine are being distributed, with 150 hospitals expected to receive doses on Monday.

The U.S. vaccination programme aims to reach 100m people by April.”

Pfizer CEO Albert Bourla Explains Why He Hasn’t Taken COVID-19 Vaccine Yet. New York Post reported:

Pfizer CEO Albert Bourla said Monday he hasn’t taken the COVID-19 vaccine yet — but only because he doesn’t want to be seen as jumping the line.

“‘I haven’t taken it yet and we are having an ethical committee dealing with the question of who is getting it,’ Bourla told CNN’s chief medical correspondent Dr. Sanjay Gupta.”

FDA Clears Pfizer Vaccine, and Millions of Doses Will Be Shipped Right Away. New York Times reported:

“The FDA’s decision followed an extraordinary sequence of events on Friday morning when the White House chief of staff, Mark Meadows, told the FDA commissioner, Dr. Stephen Hahn, to consider looking for his next job if he didn’t get the emergency approval done on Friday, according to a senior administration official who spoke on condition of anonymity because he was not authorized to discuss the matter. Dr. Hahn then ordered vaccine regulators at the agency to do it by the end of the day.

“The authorization set off a complicated coordination effort from Pfizer, private shipping companies, state and local health officials, the military, hospitals and pharmacy chains to get the first week’s batch of about three million doses to health care workers and nursing home residents as quickly as possible, all while keeping the vaccine at ultracold temperatures.”

Pfizer and Moderna Could Score $32 Billion in COVID-19 Vaccine Sales — in 2021 Alone. CNN reported:

“Wall Street analysts are projecting Pfizer and Moderna will generate $32 billion in COVID-19 vaccine revenue — next year alone.

“That doesn’t take into account the goodwill boost these companies will receive by helping to end the worst pandemic in a century. That boost is magnified for Moderna (MRNA), a young biotech company that few people had heard of before 2020 that could now be on the cusp of getting its own FDA authorization.

“Pfizer (PFE) by itself is projected to haul in $19 billion in COVID-19 vaccine revenue in 2021, according to Morgan Stanley. That’s on top of an estimated $975 million in 2020 vaccine revenue.”

Facebook Employees Won’t Be Required to Get a COVID-19 Vaccine. Tech Xplore reported:

“CEO Mark Zuckerberg told employees on Thursday that they will not be required to get vaccinated to return to the office once it begins reopening its offices, The Daily Beastfirst reported.

The tech giant confirmed to U.S. TODAY back in May that it doesn’t expect to open most of its offices until July 6 at the earliest.”

CDC Says People With History of Severe Allergic Reactions Can Get COVID-19 Vaccine. STAT reported:

“‘People that do report those types of anaphylactic reactions to other vaccines or injectables — they can still get the vaccine, but they should be counseled about the unknown risks of developing a severe allergic reaction and balance these risks against the benefit of vaccination,’ said Sarah Mbaeyi, a medical officer with the CDC’s National Center for Immunization and Respiratory Diseases.”

Australia Scraps COVID-19 Vaccine That Produced H.I.V. False Positives. New York Times reported:

“Australia on Friday canceled a roughly $750 million plan for a large order of a locally developed coronavirus vaccine after the inoculation produced false positive test results for H.I.V. in some volunteers participating in a trial study.

“Of the dozens of coronavirus vaccines being tested worldwide, the Australian one was the first to be abandoned. While its developers said the experimental vaccine had appeared to be safe and effective, the false positives risked undermining trust in the effort to vaccinate the public.”

***

December 11, 2020

FDA Advisory Panel Gives Green Light to Pfizer Vaccine. New York Times reported:

“The FDA’s vaccine advisory panel, composed of independent scientific experts, infectious disease doctors and statisticians, voted 17 to 4, with one member abstaining, in favor of emergency authorization for people 16 and older. With rare exceptions, the FDA follows the advice of its advisory panels.

“With this formal blessing, the nation may finally begin to slow the spread of the virus just as infections and deaths surge, reaching a record of more than 3,000 daily deaths on Wednesday. The FDA is expected to grant an emergency use authorization on Saturday, according to people familiar with the agency’s planning, though they cautioned that last-minute legal or bureaucratic requirements could push the announcement to Sunday or later.”

Why Paying People to Get the Coronavirus Vaccine Won’t Work. The Conversation reported:

“The idea of monetary incentives seems straightforward: Pay people to get vaccinated. One of the earliest proponents, economist Robert Litan, called the idea an ‘adult version of the doctor handing out candy to children.’”

“Litan suggested that the government should pay $1,000 to each person who receives a COVID-19 vaccine. He admitted in his proposal that he had not relied on any studies or data to get to this number, explaining that the proposed payment amount was a ‘hunch.’

“His idea has since been endorsed by prominent commentators. These include economist Gregory Mankiw and politician John Delaney, who suggested that the incentive should be increased to $1,500.”

Many Black Americans, Republicans, Women Aren’t Sure About Taking A COVID-19 Vaccine. FiveThirtyEight reported:

“Overall, 60 percent of American adults said that they would ‘definitely’ (29 percent) or ‘probably’ (31 percent) take a vaccine ‘if it were available today,’ according to a Pew Research Center poll conducted Nov. 18-29. Eighteen percent said that they would ‘definitely not’ take the vaccine, and 21 percent said that they would ‘probably not.’ Other polls have revealed similar findings (for the most part).

“A Morning Consult survey on behalf of National Geographic conducted Nov. 20-23 found 61 percent of Americans were either ‘likely’ or ‘somewhat likely’ to take a vaccine if it were approved by the FDA and made available to them. In that poll, 30 percent said they were unlikely to take the vaccine, including 19 percent who indicated they were ‘very unlikely.’ And a Gallup poll conducted Nov. 16-29 showed roughly the same splits.”

COVID-19 Vaccine Candidate Scrapped After False Positives on HIV Tests. Wall Street Journal reported:

“A COVID-19 vaccine candidate in Australia has been scrapped because recipients returned false positives on certain HIV tests, underscoring the difficulties scientists face in rapidly developing an inoculation for the coronavirus.

“The vaccine candidate, called v451, was being jointly developed by the University of Queensland and CSL Ltd. , an Australia-based biopharma company that also runs blood-collection centers in the U.S. The Australian government had agreed to buy 51 million doses.”

Canada Approves Vaccine and Could Start Shots Next Week. New York Times reported:

“The regulatory agency Health Canada approved the same vaccine, created by the American company Pfizer and a German firm, BioNTech, that was authorized in Britain and is up for a decision in the United States. Canada’s move marks another milestone in the global fight against a pandemic that has killed more than 1.5 million people, continues to spread rapidly and has driven the world into a deep economic crisis.

“Health Canada said that it had completed a rigorous, independent review of the data from clinical trials on the vaccine’s safety and effectiveness, which involved tens of thousands of people — the same kind of scrutiny applied by the U.S. Food and Drug Administration. British regulators, in giving emergency approval, relied largely on Pfizer’s own analysis of that data, the standard approach in much of the world. Bahrain approved the same vaccine on Friday.”

Sanofi Suffers Major Setback in Development of a COVID-19 vaccine. STAT reported:

“The problem relates to inadequate results in older adults in Sanofi’s Phase 1/2 trial, which the company traced back to an inadequate formulation of their vaccine, Su-Peing Ng, global medical head for Sanofi Vaccines, told STAT in an interview.

“Ng said both Sanofi and GSK are committed to continuing work on the vaccine, and plan to begin a Phase 2b trial in February.”

CVS, Walgreens Will Be First to Give Out COVID-19 Vaccines. WSBTV reported:

“When the COVID-19 vaccine is approved and shipped out, the first doses will be headed to Walgreens and CVS, which have contracts with the federal governments through Operation Warp Speed.

“The pharmacies have thousands of workers ready to hit the road, to set up mobile clinics inside nursing homes and care facilities all over the country.”

The FDA’s Green Light for a Vaccine Might Tank Ongoing Trials. Wired reported:

“Still, it’s not like Pfizer’s vaccine is going to be widely available for a while. It could be next summer before the company can provide the U.S. government with enough doses to vaccinate 100 million people. That should offer some additional incentive to study participants to stay in. And it means the bigger effect of the EUA decision will likely be for the nearly 60 vaccine candidates manufactured by other pharma companies that are currently being studied in humans. If a working vaccine is made available, fewer people may volunteer to test the competitors.

“That’s a problem because, as WIRED’s Adam Rogers has written, it’s going to take more than one or two or even three vaccines to exit this pandemic. Public health authorities want to avoid a situation in which the early success of effective but difficult-to-distribute vaccines slows the progress or even cripples the development of other shots that travel and store more easily, can be made more cheaply, or work better in certain subsets of the population.”

Massachusetts To Deliver COVID Vaccine To Residents In Three Phases Beginning In December. CBS Boston reported:

“The first round of coronavirus vaccine shipments to Massachusetts is scheduled to begin around December 15. That shipment will include 59,475 doses of Pfizer’s vaccine that will be delivered to 21 hospitals in eight counties, and to the Department of Public Health immunization lab.

“From there, doses will be sent to 74 hospitals in 14 counties for frontline workers. The next 40,000 doses will be distributed to the Federal Pharmacy Program for staff and residents of skilled nursing facilities, rest homes, and assisting living residences.”

AstraZeneca to Work on COVID Vaccine Combinations with Russia’s Sputnik V Developers. CNBC reported:

“British pharmaceutical giant AstraZeneca said Friday it would soon start work with Russia’s Gamaleya Institute to investigate whether their two coronavirus vaccine candidates could be successfully combined.

“It comes after the developers of the Sputnik V COVID-19 vaccine approached AstraZeneca via Twitter late last month to ask whether they should try combining the two common cold virus-based vaccines to boost efficacy.”

White House Threatens to Use Defense Production Act to Ensure Coronavirus Vaccine Allocation. Fox News reported:

“Health and Human Services Secretary Alex Azar said on Wednesday morning that the Trump administration may use the Defense Production Act (DPA) to ensure that the government can acquire enough vaccine doses to help stem the tide of the coronavirus pandemic in the U.S.

“Azar, discussing the U.S. government’s efforts to widely distribute a coronavirus vaccine, said that the U.S. was interested in buying 500 million additional doses of the Pfizer coronavirus vaccine and that the government was waiting for the company to commit to a certain delivery date on those doses.”

What May Happen to COVID-19 Vaccine Volunteers Who Got Placebo. ABC News reported:

“Under normal circumstances, an experiment like this would end as soon as a drug or vaccine is approved, and everyone who got a placebo would be offered the real thing. But these are not normal times. The COVID-19 vaccine would be made available through a special “emergency use authorization,” which is not the same as an FDA approval.

“With that emergency use authorization imminent, many bioethicists argue those who bravely volunteered should be immediately eligible to get the real vaccine. But others argue the nearly 44,000-person experiment should continue as if nothing had changed to ensure researchers can continue to study still-unanswered questions about the vaccine.”

***

Moderna Begins Testing COVID-19 Vaccine on U.S. Adolescents. ABC News reported:

Moderna announced Thursday that it has started testing its coronavirus vaccine candidate in adolescents.

“The company, which made one of two vaccines expected to be approved soon for adult use in the U.S., said it plans to enroll 3,000 U.S. kids as young as 12 in the trial.

“So far, there have only been a handful of attempts around the world to start exploring if any of the experimental coronavirus shots being pushed for adults also can protect children. Some U.S. pediatricians are worried they may not know if any of the shots work for young children in time for the next school year.”

Breaking: CHD Responds to News of Life-Threatening Reaction to Pfizer COVID Vaccine. Will Regulators Take Action? The Defender reported:

“On Aug. 26, Children’s Health Defense (CHD) sent a letter to Dr. Jerry Menikoff, director office for Human Research Protections Dept. of Health and Human Services regarding the Phase III Moderna mRNA-1273 vaccine. The letter requested the Office for Human Research Protections investigate the use of polyethylene glycol (PEG) in Moderna’s COVID-19 mRNA vaccine. Pfizer’s COVID vaccine, which also uses mRNA technology, also contains PEG.”

“Approximately 8% of the U.S. population has highly elevated levels of anti-PEG antibodies. The concerns we laid out in our letter about the Moderna vaccine were related to the fact that injecting a PEG-containing vaccine into individuals with pre-existing PEG antibodies could lead to life-threatening anaphylaxis.”

AP-NORC Poll: Only Half in U.S. Want Shots as Vaccine Nears. Associated Press reported:

“As states frantically prepare to begin months of vaccinations that could end the pandemic, a new poll finds only about half of Americans are ready to roll up their sleeves when their turn comes.

“The survey from The Associated Press-NORC Center for Public Affairs Research shows about a quarter of U.S. adults aren’t sure if they want to get vaccinated against the coronavirus. Roughly another quarter say they won’t.”

Worldwide Distribution of COVID-19 Vaccines Is Crucial for the Economy, Melinda Gates Says. CNN reported:

“’Everybody needs this vaccine,’ Gates, co-chair of the Bill and Melinda Gates Foundation, told CNN’s Poppy Harlow in a broadcast interview Thursday. ‘If we only get it to the high-income countries, this disease is going to bounce around. We’re going to see twice as many deaths. And our recovery of our economies is going to be much slower than if we get the vaccine out to everybody.’

The Gates Foundation on Thursday said it plans to commit an additional $250 million to support the “research, development and equitable delivery” of tools to fight Covid-19, including tests, treatments and vaccines. The announcement brings the group’s total commitments to the global Covid-19 response to $1.75 billion.”

Hackers Steal Pfizer/BioNTech COVID-19 Vaccine Data in Europe, Companies Say. Reuters reported:

“U.S. drugmaker Pfizer and its German partner BioNTech said on Wednesday that documents related to development of their COVID-19 vaccine had been “unlawfully accessed” in a cyberattack on Europe’s medicines regulator.

“The European Medicines Agency (EMA), which assesses medicines and vaccines for the European Union, said hours earlier it had been targeted in a cyberattack. It gave no further details.

“Pfizer and BioNTech said they did not believe any personal data of trial participants had been compromised and EMA “has assured us that the cyber attack will have no impact on the timeline for its review.”

FBI Warns of COVID-19 Vaccine Scams. ABC News reported:

“In October, the World Health Organization found a fake flu vaccine in Mexico, according to EUROPOL, the European Union’s law enforcement arm. EUROPOL worries the same could happen with the COVID-19 vaccine.

“’The same scenario is also likely to happen when COVID-19 vaccines do become available,’ the agency said in a press release. ‘Similar to the fake influenza vaccine encountered in Mexico, counterfeit COVID-19 vaccines may represent a significant public health threat if they are ineffective at best or toxic at worst, given their production in underground labs without hygiene standards.’”

Google to Add COVID-19 Vaccine Information Panels to Search. TechCrunch reported:

“The feature itself will appear at the top of Google.com searches for COVID-19 vaccines and will present the authoritative information in a box above the search results, linking to the health authority as the source. The panel will also have two tabs. One will be the overview of the vaccine, which appears above Top Stories and links to Local and National resources, like government websites. The other will organize news related to the vaccine under a separate section.

“Google positioned the new search panels as one way it’s helping to address vaccine misinformation and hesitance at scale.”

Will I Have to Wear a Mask Once I Get the COVID-19 Vaccine? CBS News reported:

“With three potential coronavirus vaccines showing promise, and two awaiting authorization from the FDA, state and federal officials have begun announcing ambitious distribution plans to get vaccines to millions of Americans starting as soon as next week. It will take months to reach everyone who wants the shots, but some optimistic Americans are already asking: Will I still have to wear a mask after I’m vaccinated?

“’Eventually I think we won’t, but I think until we know that this vaccine is working, we are going to have to wear a mask,’” pediatrician Dr. Dyan Hes said on CBSN.

Chicago Aims to Offer All Adults Free Covid Vaccine in 2021. Bloomberg reported:

“Chicago expects to get thousands of coronavirus vaccine doses this month and is aiming to offer them free of charge to all adult residents in 2021, city officials said Wednesday.

“After Pfizer Inc. and Moderna Inc. receive emergency federal approvals and the city gets guidance from an immunization advisory committee, Chicago can move forward with its vaccine rollout plan. The city will allocate its initial doses to its 34 hospitals the week of Dec. 14, officials said in a press release on Wednesday. Health-care workers who treat Covid patients or conduct procedures that put them at high risk for spread will be the first to receive the vaccine. Chicago has about 400,000 health workers including doctors, nurses, and other hospital staff.”

Many Black Americans Don’t Trust COVID-19 Vaccine. It’s Important to Understand Why‌. Yahoo!News reported:

“Looking at Black Americans specifically, one of the most rigorous surveys on this topic found that only 14% “mostly or completely trust” a COVID-19 vaccine will be safe, according to COVID Collaborative, a national, bipartisan organization focused on ending the pandemic. It also found that less than one-fifth, 18%, of Black Americans ‘mostly or completely trust’ a COVID-19 vaccine will be effective.

“Asked about the reason for vaccine hesitancy in the Black community, McDougle was quick to call out that many white people are hesitant, too. But for Black people, he said, the impact of the Tuskegee Study, Henrietta Lacks and Dr. J. Marion Sims are still felt.”

Berkeley Wants Teachers to Be Among First to Get COVID vaccine. Kron4 reported:

“One East Bay school district is calling on state leaders to let teachers be among the first to receive the new vaccine.

“They say teachers are essential workers and protecting them against COVID-19 would clear a huge hurdle in getting children back into the classrooms.”

COVID-19 Vaccine Distribution Must Prioritize Prisoners. The Virus Is Killing More of Them. NBC News reported:

“Indeed, many major health organizations, like the American Medical Association and John Hopkins’ Center for Health Security argue for vaccinating incarcerated and detained persons quickly because of the reality of the conditions in which they live; in prison, they are unable to maintain social distancing and often have no access to proper medical care. Congregate settings like assisted living and nursing home facilities are already top of the list; it would follow that detention centers and prisons should also be among the first places vaccines are distributed.”

***

December 9, 2020

NHS Told Not to Give Pfizer Vaccine to Extreme Allergy Sufferers After Two People Have Reaction. The Guardian reported:

“People with a history of significant allergic reactions should not have the COVID vaccine, the medicines regulator has warned, after two NHS workers experienced symptoms on Wednesday.

“Both of the NHS staff carry adrenaline autoinjectors, of which the best known brand is the EpiPen, suggesting they have suffered reactions in the past. These administer a swift adrenaline boost to counter allergic reactions which occur when some people, for instance, eat nuts.”

WHO Against Mandatory COVID Vaccines. Channel News Asia reported:

“The WHO said it would be down to individual countries as to how they want to conduct their vaccination campaigns against the coronavirus pandemic.

“But the UN health agency insisted making it mandatory to get immunised against the disease would be the wrong road to take, adding there were examples in the past of mandating vaccines use only to see it backfire with greater opposition to them.”

New York Legislation Could Make COVID-19 Vaccination Mandatory. Fox News reported:

“A New York lawmaker has proposed mandating vaccination against COVID-19 if not enough residents voluntarily get the shot once it is available.

“Assemblymember Linda Rosenthal, who represents parts of Manhattan’s West Side, earlier this month introduced a bill that would require the state to “safely and effectively” distribute an FDA-approved vaccine “in accordance with the department [of health]’s COVID-19 vaccination administration program,” according to the language of the legislation.”

FDA Says Pfizer’s COVID Vaccine Is Safe and Effective. But Trial Participants Warn of Intense Symptoms After Second Shot. CNBC reported:

“One Pfizer trial participant told CNBC that after the second shot, he woke up with chills, shaking so hard he cracked a tooth. ‘It hurt to even just lay in my bed sheet,’ he said.

Others experienced headaches and fatigue.

“The FDA said that while side effects of the Pfizer vaccine are common, there are ‘no specific safety concerns identified that would preclude issuance of an EUA.”

Biden Plans To Give 50 Million Americans COVID-19 Vaccinations In His First 100 Days. BuzzFeed News reported:

“President-elect Joe Biden is planning a vaccination program that would inoculate 50 million Americans against COVID-19 in his first 100 days in office.

“’This team will help get at least 100 million COVID-19 vaccine shots into the arms of Americans in 100 days,’ the president-elect said in a speech on Tuesday. A transition team official clarified afterward that 50 million Americans would be vaccinated — because the two most promising early vaccines require two shots per person.”

Oxford-AstraZeneca COVID Vaccine to immunize the planet ‘more effectively,’ Lancet editor says. NBC News reported:

“‘The Oxford AstraZeneca vaccine is the vaccine right now that is going to be able to immunize the planet more effectively, more rapidly than any other vaccine we have,’ Richard Horton, editor-in-chief of The Lancet, told CNBC’s ‘Street Signs Europe’ on Wednesday.

“Horton, a trained doctor himself, argued it is important to think about vaccine immunization on a global scale ‘because even if we immunize one country, the threat then is you reintroduce the virus from another country that is not protected.’”

Blunders Eroded U.S. Confidence in Early Vaccine Front-Runner. New York Times reported:

“On the afternoon of Sept. 8, AstraZeneca officials had a conference call with the Food and Drug Administration. The discussion covered important ground: What would AstraZeneca need to do to win the FDA’s blessing for the coronavirus vaccine it was developing with the University of Oxford?

“But the AstraZeneca representatives neglected to mention a crucial development: Two days earlier, the company had quietly halted trials of its vaccine around the world, including a late-stage study in the United States. It acted after a participant in Britain fell ill.”

Pfizer’s Vaccine Offers Strong Protection After First Dose. New York Times reported:

“The F.D.A. concluded that there were no “meaningful imbalances” in serious health complications, known as adverse events, between the two groups. The agency noted that four people in the vaccinated group experienced a form of facial paralysis called Bell’s palsy, with no cases in the placebo group. The difference between the two groups wasn’t meaningful, and the rate in the vaccinated group was not significantly higher than in the general population.”

China State-Backed COVID Vaccine Has 86% Efficacy, UAE Says. Bloomberg reported:

“China’s state-backed coronavirus vaccine protected 86% of people against COVID-19 in trials conducted in the United Arab Emirates, state media there reported, giving credence to the quickly developed shot that Beijing intends to distribute around the developing world.

“The data was from trials that included 31,000 volunteers in the UAE, which found the vaccine was highly effective in preventing moderate and severe cases of COVID-19 and had no serious safety concerns, according to the report, which cited the country’s Ministry of Health and Prevention.”

***

December 8, 2020

It’s True: Workers Can Be Fired for Refusing to Get a COVID-19 Vaccine. WKYC Studios Reported:

“While most Ohioans will still have to wait months to get a coronavirus vaccine, what if you don’t want one? Could you even be fired from your job if you refuse?

“Legal experts say yes.

“’Employers can require their at-will employees to get a vaccine. That’s already law,’ said Rema Ina, employment attorney at Cleveland’s Gallagher Sharp law firm, adding that many hospitals already require health care workers to get flu vaccinations as a condition of employment.”

First Britons Receive COVID-19 Vaccine, a Landmark Moment in the Pandemic. CNN reported:

“The United Kingdom has become the world’s first nation to begin vaccinating its citizens with a fully vetted and authorized COVID-19 shot, a landmark moment in the coronavirus pandemic.

“The first Briton to get the Pfizer/BioNTech vaccine — 90-year-old Margaret Keenan — received the first of two doses at 6:31 a.m. local time on Tuesday at University Hospital in Coventry, less than a week after the UK became the first country to approve it.”

Doctors Are Skeptical of Pricey Drug Given Emergency Approval for COVID. New York Times reported:

“In mid-November, an arthritis drug with a tricky name hit a pandemic milestone — then slipped back into relative obscurity.

“The drug, baricitinib, was granted an emergency authorization by the Food and Drug Administration to treat a subset of hospitalized COVID-19 patients in combination with another medication, the antiviral remdesivir. It is one of only a handful of treatments to have earned the agency’s green light.”

FDA Releases Detailed Data on Effectiveness, Risks of Pfizer’s COVID-19 Vaccine. New York Post reported:

Pfizer’s experimental coronavirus vaccine is highly effective and poses no safety risks that would prevent it from being cleared for emergency use, Food and Drug Administration scientists said Tuesday.

“FDA staffers detailed their findings in a 53-page report ahead of a Thursday meeting at which the agency’s vaccine advisory committee will consider Pfizer’s application for an emergency use authorization, which could pave the way for millions of high-risk Americans to be inoculated by the end of the year.”

55% of FDNY Firefighters Wouldn’t Get a COVID-19 Vaccine If Offered by Department, Poll Finds. CNN reported:

“Despite research that shows firefighters were 15 times more likely to be infected, a majority of those who took the poll declined the offer of a vaccine.

“Over 2,000 firefighters, or about 25% of the department’s approximately 8,200 members, responded to the poll, according to Uniformed Firefighters Association President Andrew Ansbro.”

CDC Lowers COVID-19 Quarantine Time in Effort to Increase Compliance. Very Well Health reported:

“The Centers for Disease Control and Prevention (CDC) has released alternative recommendations for the length of time a person should quarantine following exposure to a person who has been diagnosed with COVID-19.

“According to the new guidelines, close contacts of these individuals should quarantine for seven to 10 days after exposure, which is a decrease from the initially recommended 14 days. These individuals can then end their quarantines after seven days if they receive a negative test, or 10 days if they do not get tested and ‘no symptoms have been reported during daily monitoring,’ the CDC noted on its website.”

Why Vaccinate Our Most Frail? Odd Vote Out Shows the Dilemma. CNN reported.

“When shots begin to go into arms of residents, Moore said Americans need to understand that deaths may occur that won’t necessarily have anything to do with the vaccine.

“’We would not at all be surprised to see, coincidentally, vaccination happening and then having someone pass away a short time after they receive a vaccine, not because it has anything to do with the vaccination but just because that’s the place where people at the end of their lives reside,’ Moore said”

Fortune or foresight? AstraZeneca and Oxford’s Stories Clash on COVID-19 Vaccine. Reuters reported:

AstraZeneca and Oxford University have given conflicting accounts of how they came upon the most effective dosing pattern for their COVID-19 vaccine, a rare instance of public dissension between major institutions collaborating on a pivotal project.

“The discrepancy, reported for the first time by Reuters, centres on the regimen administered to a smaller group of volunteers in the late-stage trials, of half a dose followed by a full dose. This diverged from the original plan of two full doses, given to the majority of participants.”

Tennessee Bill Would Prohibit Authorities From Forcing COVID Vaccine on Someone Against Their Will. WREG-TV Memphis reported:

“East Tennessee Rep. Bud Hulsey of Kingsport proposed a bill that prohibits state and local authorities from forcing or requiring someone to receive the COVID-19 vaccine against their will.

“The legislation reads, ‘A law enforcement agency or governmental entity of this state or a local government, or the governor or chief executive of a local government by executive order, shall not force, require, or coerce a person to receive an immunization or vaccination for COVID-19 against the person’s will.’”

COVID-19 Vaccine Rollout Faces Public Concerns Over Safety. The Wall Street Journal reported:

“Governments are accelerating toward approving the first vaccines to contain COVID-19, but public anxiety over the safety of the doses is threatening to undermine those efforts.”

Trump Officials Push Ambitious Vaccine Timeline as California Locks Down. The New York Times reported:

“The Trump administration’s top health officials outlined an ambitious timetable on Sunday for distributing the first coronavirus vaccinations to as many as 24 million people by mid-January, even as the accelerating toll of the pandemic filled more hospital beds across the United States and prompted new shutdown orders in much of California.

Doctor Who Volunteered for Moderna Study Felt ‘Lousy’ After Second Shot, but Touts Vaccine. The Boston Globe reported:

“Jorge Arroyo isn’t certain whether he was injected with Moderna’s coronavirus vaccine or a placebo when he volunteered to receive two shots four weeks apart during the summer. Participants and researchers in the study at Brigham and Women’s Hospital were kept in the dark to eliminate the power of suggestion.

“But to Arroyo, it sure felt like he got the real thing.

“The Harvard-affiliated ophthalmologist ― one of about 30,000 participants in the Cambridge biotech’s nationwide trial ― says he began feeling ill about 10 hours following the second shot. The symptoms included body aches, slight nausea, and chills. What’s more, his husband, who also participated in the trial, had a similar reaction.”

***

December 7, 2020

Pfizer Chairman: We’re Not Sure if Someone Can Transmit Virus After Vaccination. The Hill reported:

Pfizer chairman Albert Bourla told Dateline host Lester Holt that the pharmaceutical company was ‘not certain’ if the vaccine prevented the coronavirus from being transmitted, saying, ‘This is something that needs to be examined.’”

Anti-Vaccine Doctor Invited to Testify Before Senate Committee. New York Times reported:

“A doctor who is skeptical of coronavirus vaccines and promotes the anti-malaria drug hydroxychloroquine as a COVID-19 treatment will be the lead witness at a Senate Homeland Security and Governmental Affairs Committee hearing on Tuesday, prompting criticism from Democrats who say Republicans should not give a platform to someone who spreads conspiracy theories.

“Dr. Jane M. Orient is the executive director of the Association of American Physicians and Surgeons, a group that opposes government involvement in medicine and views federal vaccine mandates as a violation of human rights.

“‘A public health threat is the rationale for the policy on mandatory vaccines. But how much of a threat is required to justify forcing people to accept government-imposed risks?’ Dr. Orient wrote in a statement to the Senate last year, calling vaccine mandates ‘a serious intrusion into individual liberty, autonomy and parental decisions.’”

Airports Reject Vaccine Requirement as Travel Debate Intensifies. Reuters reported:

“Airports Council International, which represents airports worldwide, joined most airlines in calling for a choice between testing or vaccination, fearing a blanket rule imposing pre-flight inoculation would be as disruptive as quarantines.

“Qantas Airways triggered the debate last week when it said a COVID-19 vaccination would be necessary for passengers on its international flights, which remain largely idle because of Australia’s strict border controls.”

‘Black Panther’ Star Slammed for Sharing Video Casting Doubt on COVID Vaccine. Miami Herald reported:

“Black Panther” star Letitia Wright says she is being “canceled” after sharing a video on Twitter that casts doubt on the COVID-19 vaccine.

In a since-deleted tweet, Wright posted a video by YouTube discussion channel On The Table, E! Online reported. The video is titled, “COVID-19 Vaccine, Should We Take It?”

Yes, Some Americans May Be Required to Get a COVID-19 Vaccine but Not by the Federal Government. USA Today reported:

“A big question remains: Will Americans be required to get vaccinated?

“For some, the short answer is yes, public health and legal experts say. But a mandate is not likely anytime soon, and likely not to come from the federal government. Instead, employers and states may condition return or access to workplaces, schools and colleges upon getting the vaccine and mandate it once the FDA issues full approval, potentially months later.

“’It’s much more likely that a private organization or company will require you to be vaccinated to get certain access to places,” said Arthur Caplan, a professor of bioethics at the New York University Grossman School of Medicine. ‘People worry about the president, governor, or county executive telling them what to do. I don’t think that’s going to happen.’”

Vaccine Opponents Rebrand as Rollout of COVID-19 Shots Looms. Politico reported:

“Longstanding vaccine opponents have rebranded themselves, forging alliances with religious and civil liberties groups to protest stay-at-home orders, business closures and mask mandates in recent months. They argue that those policies, designed to stop the spread of a deadly virus, violate their rights.

“Now this emerging coalition, which draws from both ends of the political spectrum, is turning its attention to coronavirus vaccines — and any states or employers who might try to make getting the shots mandatory. These anti-vaccine activists are seeking to capitalize on resistance to existing public health measures along with concerns that the hunt for COVID-19 shots has been politicized.

“‘With a lot of focus on COVID-19, we’re hoping to get something on protection on the COVID-19 vaccine specifically,’ said Stephanie Stock, president of the Ohio Advocates for Medical Freedom, which opposes any type of mandatory vaccination.”

FDA Could Authorize Coronavirus Vaccine ‘Within Days,’ if Hearing Goes Well: HHS Secretary. ABC News reported:

Alex Azar, the U.S. Department of Health and Human Services secretary, offered an optimistic outlook Sunday on the timeline of the first coronavirus vaccine rollout, previewing that authorization is a possibility next week, following the outcome of a Food and Drug Administration hearing.

“’If things are on track, the advisory committee goes well, I believe we could see FDA authorization within days,’ Secretary Alex Azar told ABC News Chief Anchor George Stephanopoulos on ‘This Week,’ referencing Thursday’s hearing on Pfizer’s vaccine. ‘But it’s going to go according to FDA gold-standard processes … and I’m going to make sure it does.’”

Dr. Birx: COVID-19 Vaccine Won’t ‘Save Us From This Current Surge.’ New York Post reported:

“Dr. Deborah Birx, the White House coronavirus response coordinator, warned on Sunday that a vaccine that could be authorized for use as early as this week is crucial but it will not be able to protect Americans from the recent hike in COVID cases across the country.

“‘The vaccine is critical, but it’s not going to save us from this current surge. Only we can save us from this current surge. And we know precisely what to do,’ Birx said on NBC News’ ‘Meet the Press.’”

UK Prepares to Give First COVID-19 vaccinations as the world watches. CNN reported:

“Vaccinations are set to begin on Tuesday in England, Wales and Scotland. Northern Ireland said it would start administering the vaccine early in the week but did not specify which day.

“The process, which is complicated by the need to store the Pfizer/BioNTech vaccine under strict conditions and give each recipient two doses, three weeks apart, will be closely watched from around the world.”

Iran’s Top Banker Says U.S. Blocking COVID-19 Vaccine Purchase. Al Jazeera reported:

“The United States is actively trying to prevent Iran’s efforts to buy a COVID-19 vaccine through COVAX, a global initiative undertaken by the World Health Organization, according to the chief of Iran’s central bank.

“Abdolnasser Hemmati on Monday said it must be “recorded in historical memory” that Iranian efforts to buy a vaccine through COVAX have been hampered due to money transfer issues arising due to the sanctions imposed by the US against Iran.”

Indonesia Gets First Batch of Vaccine From China’s Sinovac. Bloomberg reported:

“As many as 1.2 million doses of the vaccine arrived late on Sunday and the government expects to receive another shipment of 1.8 million in early January, according to Indonesian President Joko Widodo. Sinovac will also ship raw material for 45 million doses, which Indonesia’s state pharmaceutical firm PT Bio Farma will process locally, Widodo said in a statement.”

***

December 4, 2020

Anthony Fauci Slams U.K.’s Speedy Review of Pfizer, BioNTech COVID Shot. Fierce Pharma reported:

“‘If you go quickly and you do it superficially, people are not going to want to get vaccinated,’ National Institute of Allergy and Infectious Diseases Director Anthony Fauci, M.D., told Fox News. ‘We have the gold standard of a regulatory approach with the FDA.’

“The U.K.’s Medicines and Healthcare products Regulatory Authority (MHRA) ‘did not do it as carefully,’ he added. Less than a day after making his remarks, Fauci apologized, telling the BBC he has ‘great faith’ in U.K. regulators.”

COVID-19 Vaccines May Not Work on Nursing Home Patients. Is It Worth the Risk to Try Anyway? Los Angeles Times reported:

“It’s a profile starkly different than that of patients who live in long-term care facilities. Retired from active life, they are on the receiving end of medical care. Indeed, they are so medically fragile that some fear the vaccine itself could hasten their demise.

“If vaccines for diseases like the flu are any guide, the new COVID-19 shots may not be particularly effective in nursing home residents. The aging immune system is notoriously difficult to rouse with vaccines.”

Vaccines’ Side Effects Risk Sidelining Health Workers While Cases Surge. Bloomberg reported:

COVID-19 vaccine side-effects that range from fevers and chills to headaches and joint pain could keep some doctors and nurses from working amid a nationwide surge in hospitalizations.

“Health systems are gearing up to vaccinate key hospital staff with the Pfizer Inc. and Moderna Inc. coronavirus shots, which could start shipping in the U.S. in a matter of weeks, pending emergency-use authorizations.”

Coronavirus Vaccines Coming, but Johns Hopkins Experts Say Some Vital Questions Remain Unanswered. Baltimore Sun reported:

“But even if vaccines become widely available before the end of the year, many more months of study, clinical trial testing and research will be required before vaccines can be deemed effective, said Dr. William Moss, executive director of the International Vaccine Access Center at the Johns Hopkins Bloomberg School of Public Health, during a virtual media briefing Thursday.”

CDC to Encourage ‘Vaccinated for COVID-19’ Buttons. ABC News reported:

“The Centers for Disease Control and Prevention is planning to offer health care providers a template they can use to print buttons or stickers that would advertise a person’s vaccination status. The idea is that the button would be handed out to patients after they receive their vaccination shots.

“The effort is part of a ‘toolkit’ that the CDC plans to provide healthcare systems to ‘educate and promote vaccination,’ a CDC spokesperson told ABC News.”

‘Absolutely Normal’: COVID Vaccine Side Effects Are No Reason to Avoid the Shots, Doctors Say. Washington Post reported:

“Ahead of the anticipated distribution of Moderna’s two-dose vaccine and a similar vaccine developed by Pfizer and German biotechnology company BioNTech, which could be coming in a matter of weeks, experts have stressed the importance of transparent messaging in ensuring wide public acceptance and completion of the vaccination regimens. Though a full detailed analysis of the safety profile of the vaccines is forthcoming and will be a topic of discussion at the Food and Drug Administration’s advisory committee meetings this month, the drugmakers’ disclosures about the possible side effects coupled with anecdotal reports from trial participants have prompted concern among some experts that people may be hesitant to get vaccinated or won’t come back for their second dose.”

Ex-Presidents Would Get Vaccine Publicly to Boost Confidence. Associated Press reported:

“Three former presidents say they’d be willing to take a coronavirus vaccine publicly, once one becomes available, to encourage all Americans to get inoculated against a disease that has already killed more than 275,000 people nationwide.

“Former President Barack Obama said during an episode of SiriusXM’s ‘The Joe Madison Show’ airing Thursday, ‘I promise you that when it’s been made for people who are less at risk, I will be taking it.’”

Incomplete Data Stalls Swiss Authorisation of COVID-19 Vaccines. SWI reported:

“The regulator said important data on safety, efficacy and quality are still missing. It has reached out to the manufacturers, who provided data from their studies.

“‘We lack data on the effectiveness of the clinical trials and on the important subgroups that participated in these large studies,’ said Claus Bolte, head of the authorisation division at Swissmedic, at a press briefing on Tuesday organised by the Federal Office of Public Health.”

How COVID-19 Highlights the Uncertainty of Medical Testing. Kaiser Health News reported:

“‘People think a positive test equals disease and a negative test equals not disease,’ said Dr. Deborah Korenstein, who heads the general medicine division at Memorial Sloan Kettering Cancer Center in New York City. ‘We’ve seen the damage of that in so many ways with COVID.’”

MDA Wants Neuromuscular Disease Patients to Have Early Access to COVID-19 Vaccine. ALS News Today reported:

“The Muscular Dystrophy Association (MDA) is encouraging the U.S. Centers for Disease Control and Prevention (CDC) to recommend that people living with neuromuscular diseases (NMDs) have early access to any federally approved COVID-19 vaccine.

“The MDA made its request in a letter to members of the CDC Advisory Committee on Immunization Practices (ACIP), who are helping to guide the allocation and distribution of the COVID-19 vaccine. The MDA represents more than 300,000 U.S. residents who have one of some 40 NMDs.”

Spit in a Tube and Mail It In: A New Frontier in Coronavirus Testing. New York Times reported:

“Testing has long been one of the keys to controlling the spread of a virus that with the onset of winter is entering its most dangerous phase. Yet even as cases per capita have rocketed, securing a test has become enough of an ordeal that many people have been dissuaded from even trying.

“That has begun to change in recent weeks as a handful of communities across the country have rolled out the first do-it-yourself home saliva tests, which require users to simply dribble into a test tube, seal it and send it to a lab.”

First ‘Mass Air Shipment’ of Pfizer’s COVID Vaccine Arrives as Airlines Prepare for More. CNBC reported:

“The Federal Aviation Administration said it supported the “first mass air shipment” of COVID-19 vaccines, as pharmaceutical companies and airlines prepare networks for broad distribution.

“United Airlines carried Pfizer’s COVID-19 vaccine from Brussels to Chicago O’Hare International Airport on Friday, according to people familiar with the matter.”

***

December 3, 2020

Vaccination Cards Will Be Issued to Everyone Getting COVID-19 Vaccine, Health Officials Say. CNN reported:

“’Everyone will be issued a written card that they can put in their wallet that will tell them what they had and when their next dose is due,’Moore said. ‘Let’s do the simple, easy thing first. Everyone’s going to get that.’

“Vaccination clinics will also be reporting to their state immunization registries what vaccine was given, so that, for example, an entity could run a query if it didn’t know where a patient got a first dose.”

Come for Your Eye Exam, Leave With a Band-Aid on Your Arm. Kaiser Health News reported:

“In California, the professional organizations representing dentists and optometrists are in talks with state officials to expand their job descriptions to include administering vaccines. Oregon has already begun training and certifying dentists to give vaccines. And at least half the states have considered allowing dentists to administer COVID vaccines once they’re available, according to the American Association of Dental Boards.

“That list is likely to grow, because the U.S. Centers for Medicare & Medicaid Services recommended in October that states consider expanding their list of vaccine providers.”

‘You Need to Assume You Became Infected’ at Thanksgiving: White House Task Force Warning. ABC News reported:

“Americans who celebrated Thanksgiving with other people outside their household should assume they are infectious and a ‘dangerous to others,’ the White House Coronavirus Task Force is warning in a startling new report obtained by ABC News.

“Delivered Nov. 29 to the nation’s governors, but not released publicly, President Donald Trump’s top pandemic advisers said it’s up to state and local public health officials to alert the public as COVID-19 cases hit an all-time high.”

Support for Mandatory COVID Vaccine Down From 72% to 59% in Canada. LifeSiteNews reported:

“The poll also asked respondents to give their opinions on the speed of COVID-19 vaccine development. The vast majority, 71 percent, said taking a vaccine that was approved so fast makes them nervous, with 69 percent saying they have concerns for potential harmful long-term effects of the vaccine.

“When respondents were given detailed conditions under which they would agree to take a COVID-19 vaccine “without hesitation once approved,” only 19 percent said they would be willing to do so.”

Health Advisers Rename ‘Adverse Reactions’ to COVID-19 Vaccine. Mercola.com reported:

“If you start hearing about ‘immune responses’ that many people have in conjunction with the COVID-19 vaccine, be aware: This is the new name for adverse reactions. In other words, the COVID-19 vaccine no longer has ‘adverse reactions’ but, rather, the bad side effects you feel — some of which could be very serious — are now called “immune responses.”

“This information was buried at the bottom of an article by CNBC in connection with the news that 10% to 15% of vaccine recipients will suffer ‘significantly” noticeable’ side effects. Some health officials are concerned that the connotation of ‘side effects’ and ‘adverse reactions’ may be off-putting to the public, so in an attempt to reprogram how you think about the side effects, one health practitioner suggested changing the definition of “adverse reactions” to ‘immune response.’”

When Will Children Get Coronavirus vaccine? Not in Time for New School Year, Experts Fear. Washington Post reported:

“On Sunday, Anthony S. Fauci, director of the National Institute of Allergy and Infectious Diseases, acknowledged it is going to take time, perhaps even months, before those younger than 18 can get a coronavirus vaccine, as trials to test the vaccine candidates’ immunogenicity are either underway or have yet to begin. Pfizer, which is developing a vaccine with German partner BioNTech, announced in October they were expanding testing of their vaccine to those 12 and older. A similar announcement is expected soon from Moderna, which has partnered with the National Institutes of Health on an experimental vaccine, with Fauci hinting an expedited process to test the vaccine in children would begin ‘very likely in January.’”

Many Trial Volunteers Got Placebo Vaccines. Do They Now Deserve the Real Ones? New York Times reported:

“But on Wednesday, 18 leading vaccine experts — including a top regulator at the Food and Drug Administration — argued that vaccinating placebo groups early would be disastrous for the integrity of the trials. If all of the volunteers who received placebo shots were to suddenly get vaccinated, scientists would no longer be able to compare the health of those who were vaccinated with those who were not.

“‘If you’re going to prioritize people to get vaccinated, the last people you should vaccinate are those who were in a placebo group in a trial,’ said Richard Peto, a medical statistician at the University of Oxford. Mr. Peto and his colleagues laid out their concerns in a new commentary in The New England Journal of Medicine.”

IBM Uncovers Global Email Attack on COVID Vaccine Supply Chain. CNBC reported:

“‘We assess that the purpose of this campaign may have been to harvest credentials to gain future unauthorized access,’ IBM researchers Claire Zaboeva and Melissa Frydrych wrote in a report. ‘From there, the adversary could gain insight into internal communications, as well as the process, methods and plans to distribute a COVID-19 vaccine.’

“IBM said the attacks likely targeted organizations linked to Gavi, The Vaccine Alliance, which is working to supply low- and middle-income economies with an affordable coronavirus vaccine. The alliance, which is backed by the Bill & Melinda Gates Foundation, operates a program alongside UNICEF to strengthen immunization supply chains to ensure the drugs are distributed equitably.”

China Has Promised Millions of Coronavirus Vaccines to Countries Globally. And It Is Ready to Deliver Them. CNN reported:

“China currently has five coronavirus candidates from four companies which have reached phase 3 clinical trials, the last and most important step of testing before regulatory approval is sought.

“Having largely eliminated the coronavirus inside its borders, Chinese drugmakers had to look abroad for places to test the efficacy of their vaccines. Together, they have rolled out phase 3 trials in at least 16 countries.”

***

December 2, 2020

UK Authorizes Pfizer Coronavirus Vaccine for Emergency Use. Associated Press reported:

“The go-ahead for the vaccine developed by American drugmaker Pfizer and Germany’s BioNTech comes as the virus surges again in the United States and Europe, putting pressure on hospitals and morgues in some places and forcing new rounds of restrictions that have devastated economies.

“The Medicines and Healthcare Products Regulatory Agency, which licenses drugs in the U.K., recommended the vaccine could be used after it reviewed the results of clinical trials that showed the vaccine was 95% effective overall — and that it also offered significant protection for older people, among those most at risk of dying from the disease. But the vaccine remains experimental while final testing is done.”

Healthcare Workers and Nursing Home Residents Should Be First to Get Coronavirus Vaccines, CDC Advisory Group Says. Washington Post reported:

“The first doses of a coronavirus vaccine should be given to an estimated 21 million health-care workers and three million residents and staff of nursing homes and other long-term care facilities, a federal advisory panel recommended Tuesday afternoon.

“These groups were deemed the highest priority by the Advisory Committee on Immunization Practices, because the vaccine will initially be in extremely short supply after it is cleared by federal regulators. Health-care personnel are a top priority because of their exposure to the virus and their critical role keeping the nation’s hospitals and clinics functioning.”

COVID-19 Vaccines Face a Varied and Powerful Misinformation Movement Online. NBC News reported:

The side effects, which come from the vaccine shots, can last up to a day and a half, said Dr. Moncef Slaoui, who is leading the Trump administration’s COVID-19 vaccine program Operation Warp Speed. The people who’ve suffered from side effects have reported redness and pain at the injection site as well as fever, chills, muscle aches and headaches, he said, adding most people have no noticeable side effects.

“‘The longer, more important kind of adverse events such as some autoimmune disease or others have not been reported in a different way between the placebo group and the vaccine group in these two trials, which is very reassuring,’” he told The Washington Post. “‘I always make sure we say that [while] we know the short term and I’m going to call it midterm effects of the vaccine is now well understood, the very long-term safety is not yet understood by definition.’”

Trump COVID Vaccine Czar Says Side Effects ‘Significantly Noticeable’ in 10% to 15% of Recipients. CNBC reported:

The side effects, which come from the vaccine shots, can last up to a day and a half, said Dr. Moncef Slaoui, who is leading the Trump administration’s COVID-19 vaccine program Operation Warp Speed. The people who’ve suffered from side effects have reported redness and pain at the injection site as well as fever, chills, muscle aches and headaches, he said, adding most people have no noticeable side effects.”

The Cold Rush: Pfizer’s COVID Vaccine Jump-Starts Race for Special Freezers. Washington Post reported:

“Before the pandemic, ultracold freezers were a relatively niche market, supplying pharmaceutical companies, hospital labs and universities with the specialized and prohibitively costly cooling units.

“Now, with the challenge of international vaccine distribution looming, ULT freezers are becoming much sought after, much like personal protective equipment and ventilators in the early months of the pandemic.

Ford has announced it is acquiring its own ultracold freezers to supply employees with Pfizer’s vaccine. Hospital systems, logistics and delivery companies are also gearing up.”

***

December 1, 2020

Fauci Asks Americans to Prepare to Get Vaccinated as States Plan for Distribution. CNN reported:

As the U.S. prepares for the first round of vaccinations to tackle COVID-19, infectious disease expert Dr. Anthony Fauci called on the public to ‘be part of the solution’ and get vaccinated once it is available.

“’Say, ‘I’m not going to be one of the people that’s going to be a steppingstone for the virus to go to somebody else. I’m going to be a dead end to the virus,’ Fauci told Facebook CEO Mark Zuckerberg Monday.”

Moderna Applies for Emergency F.D.A. Approval for Its Coronavirus Vaccine. New York Times reported:

“Mr. Bancel said the company was ‘on track’ to produce 20 million doses by the end of December, and 500 million to a billion in 2021. Each person requires two doses, administered a month apart, so 20 million doses will be enough for 10 million people.

Moderna is the second vaccine maker to apply for emergency use authorization; Pfizer submitted its application on Nov. 20. Pfizer has said it can produce up to 50 million doses this year, with about half going to the United States. Its vaccine also requires two doses per person.”

CDC Panel Set to Vote Tuesday on Who Gets Coronavirus Vaccine First. NBC News reported:

“The meeting with the Advisory Committee on Immunization Practices, or ACIP, an outside group of medical experts that advises the CDC, comes a day after Moderna requested emergency clearance from the U.S. Food and Drug Administration for its COVID-19 vaccine. Pfizer, which is working with German drugmaker BioNtech, applied for the same authorization on Nov. 20. U.S. officials expect the first doses of one of the vaccines could be distributed in a few weeks — even before the end of the year.”

GM Preps to Unveil Plan to Workers Around COVID-19 Vaccine Distribution. Detroit Free Press reported:

“General Motors is preparing a plan for the arrival of COVID-19 vaccines that it will likely unveil to workers this month.

 “GM has been talking with local health department and government leaders to coordinate who will be leading and conducting vaccine distribution, GM spokesman David Caldwell told the Free Press Monday.”

Serum Institute’s COVID-19 Vaccine Triggers ‘Behavioural Change’ in Participant; Drug Regulator Silent. National Herald reported:

“A 40-year-old man who volunteered for ‘Covishield’, the vaccine being tested by Pune-based Serum Institute of India (SII), has sued the company for Rs 5 crore. He stated that the vaccine triggered an adverse reaction, including memory loss and an inability to get back to life before being administered the vaccine. SII has partnered with AstraZeneca and Oxford University for producing the vaccine in India.”

Oxford Controversy Is the First Shot in International Battle Over Vaccine Efficacy. Guardian reported:

“In a few days, researchers plan to solve a medical mystery that threatens to erupt into a major transatlantic battle. Scientists at Oxford University say they intend to publish full, peer-reviewed data, in the journal Lancet, about trials they have completed on their COVID-19 vaccine.

The information, they say, should end mounting controversy about the vaccine’s effectiveness and explain apparent inconsistencies in trial results. Opponents, most of them American, say this is unlikely, and insist new phase 3 trials now need to be restarted from scratch to restore confidence in the vaccine.”

Some Health are Workers Are Wary of Getting COVID-19 Vaccines. NPR reported:

“Health care workers are expected to be first in line to be offered a COVID-19 vaccine when one is available.

“But the speed of COVID-19 vaccine development, along with concerns about political interference with the process, has left some health care workers on the fence about COVID-19 vaccines.”

***

November 27, 2020

As COVID-19 Vaccine Nears, Employers Consider Making It Mandatory. NPR reported:

The U.S. Occupational Safety and Health Administration has stated that employers can legally impose a flu vaccine requirement on their workforce, but employees have the right to request medical or religious exemptions under federal anti-discrimination laws. Each claim must be evaluated on its own merits, a time-consuming process for employers.

“While it may be legal for employers to compel their workers to get the COVID-19 vaccine, doing so would be a huge, difficult undertaking, says Y. Tony Yang, executive director of the Center for Health Policy and Media Engagement at George Washington University, who has argued against COVID-19 vaccine mandates.”

The Virus Won’t Stop Evolving When the Vaccine Arrives. New York Times reported:

“But vaccines won’t put an end to the evolution of this coronavirus, as David A. Kennedy and Andrew F. Read of The Pennsylvania State University, specialists in viral resistance to vaccines, wrote in PLoS Biology recently. Instead, they could even drive new evolutionary change.

“There is always the chance, though small, the authors write, that the virus could evolve resistance to a vaccine, what researchers call “viral escape.” They urge monitoring of vaccine effects and viral response, just in case.”

Americans should be warned of coronavirus vaccine side effects, medical experts say. Fox News reported:

“Meanwhile, during the online meeting with the Advisory Committee on Immunization Practices, Patsy Stinchfield, a nurse practitioner at Children’s Minnesota, suggested that public health officials change the language used when warning the public about side effects. She recommended using the word “response” rather than ‘adverse reaction,’ per CNBC.

“‘These are immune responses,’ said Stinchfield. ‘And so if you feel something after vaccination, you should expect to feel that. When you do, it’s normal to have some arm soreness or fatigue, some body aches and maybe even a fever. It sounds like in some of these trials, maybe even having to stay home from work.’”

After Admitting Mistake, AstraZeneca Faces Difficult Questions About Its Vaccine. New York Times reported:

“But since unveiling the preliminary results, AstraZeneca has acknowledged a key mistake in the vaccine dosage received by some study participants, adding to questions about whether the vaccine’s apparently spectacular efficacy will hold up under additional testing.

“Scientists and industry experts said the error and a series of other irregularities and omissions in the way AstraZeneca initially disclosed the data have eroded their confidence in the reliability of the results.”

The AstraZeneca Covid Vaccine Data Isn’t Up to Snuff. Wired reported:

“Monday’s press release from AstraZeneca presents “convincing evidence that [the vaccine] works,” said Science. But not everyone has been convinced. The price of AstraZeneca’s shares actually dropped on the news, and an analysis from an investment bank concluded, ‘We believe that this product will never be licensed in the US.’ Over at STAT News, Anthony Fauci cautioned that we’ll need to see more data before coming to a conclusion. The skeptics have strong reasons to be concerned: This week’s ‘promising’ results are nothing like the others that we’ve been hearing about in November — and the claims that have been drawn from them are based on very shaky science.”

The Healthcare System Has Failed Black Americans. No Wonder Many Are Hesitant About a Vaccine. Washington Post reported:

“But I have heard from Black friends and family members who say they don’t want to take a coronavirus vaccine. Some have misgivings about whether a vaccine produced so fast would be safe; others say they don’t trust pharmaceutical companies to be transparent about risks. They aren’t alone. A September survey by the nonprofit COVID Collaborative found that fewer than half of Black people said they would definitely or probably take a vaccine made available at no charge. Just 14 percent said they trusted it would be safe. A Pew Research Center poll, also from September, illuminated the stark difference in attitudes by race: It found that 32 percent of Black adults would definitely or probably take a vaccine when available, compared with 52 percent of Whites and 56 percent of Hispanics.”

Poll: Many People Insist They Will Not Get a COVID-19 Vaccine. Komo News reported:

“[Bernadette] Pajer is the public policy director for Informed Choice Washington — an organization that doesn’t identify as anti-vaccine, but says they believe in healthy immunity and personal freedoms.

While doctors strongly disagree, Pajer says that getting a vaccine for coronavirus is unnecessary and possibly dangerous.

“’We do not know the long-term health impacts of this vaccine,’” said Pajer.

In China, Nearly 1 Million People Have Reportedly Already Gotten a Coronavirus Vaccine. Vox reported:

The vaccinations have occurred as part of an emergency use program that began in late July, though few details about it have been revealed by the Chinese government. What we do know is that as part of the program, China’s State Council authorized high-risk groups including medical workers, customs officials,\ and transportation workers to start receiving one of three Chinese-made vaccines — two from Sinopharm and one produced by Sinovac. But some Chinese cities have also been offering the vaccines to members of the public.”

Feds on COVID-19 mRNA Vaccine Distribution: Pfizer’s Dry Runs Predict a ‘Very Doable Process.’ Fierce Pharma reported:

Alex Azar, secretary of health and human services, acknowledged during a press conference Tuesday that the logistics — which include the need for ultra-cold storage — will be far from easy. But Azar and two other top officials running the government’s Operation Warp Speed effort to speed COVID-19 vaccine distribution did their best to boost the public’s confidence.”

Iowa State Taps Device Maker Zeteo for Early Work on Nasal Spray COVID-19 Vaccine. Fierce Pharma reported:

“The Nanovaccine Institute at Iowa State University says it’s developing a next-generation nanovaccine against SARS-CoV-2, the virus that causes COVID-19, and it recently tapped drug delivery specialist Zeteo Biomedical to lend its device and technical support, the partners announced separately.“Nanovaccines like Iowa State’s work by loading viral proteins into nanoparticles, about 300 billionths of a meter across, made from biodegradable polymers, the institute said in a release. Crucially, Iowa State’s candidate will be formulated as a single-dose nasal spray, deliverable by way of a solitary sniff.”

***

November 24, 2020

More Than Two-Thirds of Americans Oppose Mandatory COVID-19 Vaccinations. ZeroHedge reported:

“Opinion polling is clear: In the US, more than two thirds of the population feels receiving a COVID-19 vaccine should be voluntary. What’s more, only a small percentage of Americans would push to be vaccinated within the first month of a vaccine being widely available. Most appear content to hang back, presumably more concerned about when the economy will be allowed to reopen than when they might be able to get vaccinated.”

Doctors Say CDC Should Warn People the Side Effects From COVID vaccine Shots Won’t Be ‘a Walk in the Park.’ CNBC reported:

“Public health officials and drugmakers must be transparent about the side effects people may experience after getting their first shot of a coronavirus vaccine, doctors urged during a meeting Monday with CDC advisors as states prepare to distribute doses as early as next month.

“Dr. Sandra Fryhofer of the American Medical Association noted that both Pfizer’s and Moderna’s COVID-19 vaccines require two doses at varying intervals. As a practicing physician, she said she worries whether her patients will come back for a second dose because of the potentially unpleasant side effects they may experience after the first shot.”

Teenagers Are Latest participants in COVID-19 Vaccine Trials; Safety Concerns Arise. Fox Business reported:

“Around 400 children, ages 16 and 17, have enrolled in the study, which administers two doses of Pfizer’s experimental vaccine, in addition to about 100 children in the 12 to 15 age group. After the safety review confirms that testing can continue, the clinic will aim to enroll up to 2,600 between the ages of 12 to 18 nationwide.”

Moderna Boss Says COVID-19 Vaccine Not Proven to Stop Spread of Virus. New York Post reported:

Moderna’s coronavirus vaccine may not get life back to normal right away because it hasn’t yet been proven to prevent the deadly bug from spreading, the company’s top doctor says.

“Research has shown that the biotech firm’s shot is effective at preventing people from getting sick with COVID-19, but there’s no hard evidence that it stops them from carrying the virus ‘transiently’ and potentially infecting others who haven’t been vaccinated, according to Dr. Tal Zaks, Moderna’s chief medical officer.”

Experts Have Questions About AstraZeneca’s Vaccine Data. CNN reported:

“Vaccine experts — including those who serve on advisory committees for the U.S. Food and Drug Administration and the U.S. Centers for Disease Control and Prevention — have questions about data released Monday by AstraZeneca about its COVID-19 vaccine.”

“In a press release Monday, the pharmaceutical giant announced that its vaccine is on average 70% effective. However, the company did not state the data that led them to that conclusion.”

Coronavirus Vaccines Face Trust Gap in Black and Latino Communities, Study Finds. Washington Post reported:

“If offered a coronavirus vaccine free of charge, fewer than half of Black people and 66 percent of Latino people said they would definitely or probably take it, according to a survey-based study that underscores the challenge of getting vaccines to communities hit hard by the pandemic.

“The survey released Monday is one of the largest and most rigorous to date. Other recent studies have also pointed to vaccine hesitancy in communities of color, but Monday’s survey delved deeper into the reasons, polling respondents on a spectrum of questions to get at the roots of their distrust.”

Doctors and Nurses Want More Data Before Championing Vaccines to End the Pandemic. Washington Post reported:

“Medical experts said attitudes among doctors, nurses and the public could shift quickly as new data are revealed. But government, academic, and health-care officials say that significant numbers of providers want more data about the vaccine before it is deployed. Some of the information is expected to be released next month by the FDA.”

“A report released Thursday by the University of California at Los Angeles researchers said that 66 percent of Los Angeles health-care workers who responded to an online questionnaire (not a randomized sample) said they would delay taking a vaccine. The American Nurses Association, a national union, said one-third of its members do not intend to take the vaccine, and an additional third are undecided.”

Tennessee Bill Would Expand Coronavirus Vaccine Exemptions. WATE.com reported:

“Tennessee would no longer prohibit parents from refusing vaccinations of their children under a newly filed proposal as COVID-19 cases continue to rise.

“Tennessee law currently allows parents to cite several exemptions to not immunize their children as long as the state isn’t in an epidemic.”

Bill Gates Says AstraZeneca, Johnson & Johnson, Novavax COVID-19 Vaccines All Likely To Prove ‘Very Efficacious And Safe’ By February. Yahoo Finance reported:

“‘I’m optimistic that by February, it’s very likely they’ll all prove very efficacious and safe,’ said Gates.

“Gates’ foundation has backed the development of a vaccine for COVID-19 and said its entire focus was on fighting the pandemic.”

AstraZeneca Vaccine Up to 90% Effective and Easily Transportable, Says Company. Washington Post reported:

“The Oxford-AstraZeneca vaccine is likely to be cheaper than those made by Pfizer and Moderna, and it does not need to be stored at subzero temperatures but can be kept in ordinary refrigerators in pharmacies and doctor’s offices.

AstraZeneca executives said the vaccine is already being manufactured. The first 4 million doses could be ready in December, and 40 million could be delivered in the first quarter of 2021, they said. By the spring, the company and its global partners in India, Brazil, Russia and the United States could be cranking out 100 million to 200 million doses a month.”

Pfizer Aims to Ship COVID-19 Vaccine Doses ‘Within Hours’ of Regulatory Nods, CEO Says. Will a ‘Race to Regulate’ Ensue? Fierce Pharma reported:

“This week, the FDA official in charge of overseeing the vaccine review process said the agency’s detailed look at the data will take weeks, not days. High-priority vaccinations could begin in the U.S. next month, with everyday Americans getting vaccines as soon as April, U.S. health officials said this week.

Pfizer has already made 20 million doses and plans to produce around 50 million by the end of 2020. The company has a much more ambitious goal of 1.3 billion doses for 2021.”

***

November 20, 2020

2 Companies Say Their Vaccines Are 95% Effective. What Does That Mean? New York Times reported:

“From the headlines, you might well assume that these vaccines — which some people may receive in a matter of weeks — will protect 95 out of 100 people who get them. But that’s not actually what the trials have shown. Exactly how the vaccines perform out in the real world will depend on a lot of factors we just don’t have answers to yet — such as whether vaccinated people can get asymptomatic infections and how many people will get vaccinated.”

Over Half of Adults Over 50 Say They’ll Get Vaccinated Against COVID-19, But Many Will Want to Wait, Poll Finds. Newswise reported:

“In all, 58% of adults aged 50 to 80 say they are somewhat or very likely to get vaccinated to prevent COVID-19, according to new results from the National Poll on Healthy Aging from the University of Michigan.

That number went up to 66% when the poll team asked the question a different way: 20% said they’d want to get vaccinated right away when vaccines become available, but 46% said they’d rather wait for others to get vaccinated first before doing it themselves.”

Pfizer and BioNTech to Request Emergency Authorization From FDA for COVID vaccine. CNBC reported:

“If Pfizer’s application is approved, the vaccine will likely be limited and rolled out in phases, with health-care workers, the elderly and people with underlying health conditions getting the first inoculations. Essential workers, teachers and people in homeless shelters and prisons would likely be next, followed by children and young adults.

“The FDA process is expected to take a few weeks, and an advisory committee meeting to review the vaccine has been tentatively scheduled for early December. Some Americans could get their first dose of the vaccine in about a month.”

Doing the Touchy Math on Who Should Get a COVID Vaccine First. Scientific American reported:

“‘But figuring out how to allocate vaccines — there are close to 50 in clinical trials on human — to the right groups at the right time is “a very complex problem,’ says Eva Lee, director of the Center for Operations Research in Medicine and Health Care at the Georgia Institute of Technology. Lee has modeled dispensing strategies for vaccines and medical supplies for Zika, Ebola, and influenza, and is now working on COVID-19. The coronavirus is ‘so infectious and so much more deadly than influenza,’ she says. ‘We have never been challenged like that by a virus.’”

When Will COVID-19 Vaccines Be Widely Available? Feds Lay out Ambitious Timeline. Fierce Pharma reported:

“High-priority populations such as healthcare workers and nursing home residents could obtain COVID-19 vaccines in December, Department of Health and Human Services Secretary Alex Azar said in a press conference. Anthony Fauci, M.D., director of the National Institute of Allergy and Infectious Diseases, predicted in a meeting with USA Today’s editorial board that everyday Americans could be vaccinated as early as April.”

COVID-19 Vaccines: No TIme for Complacency: The Lancet reported:

“Unfortunately, the trials’ results were announced via press releases, leaving many scientific uncertainties that will dictate how the vaccines will affect the course of the pandemic. Little safety data are available. How well the vaccines work in older people or those with underlying conditions and their efficacy in preventing severe disease are still unclear. Peer-reviewed publication should resolve these issues, but other questions will not be answerable for some time. For one, the duration of protection is unknown and will have a huge bearing on the practicalities and logistics of immunisation (will boosters be needed? How often?).”

***

November 19, 2020

America’s Doctors Say COVID-19 Vaccine Trials Must Start Including Kids — Now.  Huffington Post reported:

“‘We eagerly anticipate seeing the safety and efficacy data in vaccine trials that are underway in adults, and urge pharmaceutical companies to rapidly expand their participant panels to include children and adolescents,’” Dr. Yvonne Maldonado, chair of the [American Academy of Pediatrics] Committee on Infectious Diseases, said in a press statement.

Once Approved, First COVID-19 Vaccine Doses Will Go Out in 24 Hours, Official Says. Spectrum News reported:

“‘We will begin distribution of the vaccine within 24 hours after Emergency Use Authorization is approved,’ Army Gen. Gustave Perna, who is leading Operation Warp Speed, said in a media briefing Wednesday. ‘Then we will begin a weekly cadence of delivery of [the] vaccine.’”

As Vaccine Approvals Loom, U.S. Funds A Back-Up Plan For Delivery. NPR reported:

“As the nation gears up for a massive vaccination effort, the Trump administration is doubling down on a novel, unproven injection device by providing more than half a billion dollars in government financing for something that is still awaiting Food and Drug Administration approval.”

Oxford-AstraZeneca COVID Vaccine Shows Robust Immune Response Among Older Adults. CNBC reported:

“The study of 560 healthy adults, including 240 over age 70, found the vaccine to be safe and produced a similar immune response among people age over 56 and those ages 18 to 55.

“Older people face a “significant risk” of developing severe illness on contracting COVID-19, the WHO has said, citing decreased immune function and potential underlying health conditions. People of all ages are at risk of contracting the virus, however.”

Pfizer Declares Its Vaccine is 95% Effective. Bloomberg reported:

Pfizer said a final analysis of its clinical-trial data showed its COVID-19 vaccine, developed with the help of the German government and Germany-based BioNTech, was 95% effective, which may pave the way for the company to obtain regulatory authorizations for its use. Scientists however are calling for the release of more data on the new medicine — which faces huge logistical hurdles when it comes to distribution — so it can be independently reviewed and analyzed. Rivals including Moderna, meanwhile, are close behind with their own drugs, which may be easier to ship. The Pfizer statement comes a week after the pharmaceutical giant said it had positive preliminary information on the potential vaccine. At the time, the company’s stock soared, and Chief Executive Officer Albert Bourla made $5.6 million selling his shares.”

Fauci Says the Average American Could Get Vaccinated Against COVID-19 as Soon as April: ‘I Would Take the Vaccine.’ USA Today reported:

“If most of the population is vaccinated by summer and fall, Fauci said, people can start looking forward to returning to pre-pandemic normalcy.

“‘Then you can start talking about this umbrella or blanket of protection on society that would diminish dramatically the risk of a person being exposed or even being infected,’ he said. ‘When so many people are protected, that’s when you get into the real herd immunity.’”

Trump Officials See Surge in Sign-Ups for Free CVS, Walgreens COVID Vaccine Program for Seniors. CNBC reported:

“The Trump administration said Wednesday that it is seeing ‘tremendous uptake’ of a program that will allow CVS Health and Walgreens to administer coronavirus vaccines to seniors in long-term care facilities.

“Health and Human Services Secretary Alex Azar said that 99% of skilled nursing facilities across the country have signed up for the program, which will give COVID-19 vaccines to seniors free of charge and will be available to residents in all long-term care settings, including skilled nursing facilities, assisted living facilities, residential care homes and adult family homes. He said 100% of facilities in 20 states are signed up.”

Johnson & Johnson Expects Coronavirus Vaccine to Be Ready for Approval by February, Report Says. Fox News reported:

“Johnson & Johnson’s lead scientist said the company expects to have all data needed to file for authorization for its single-shot coronavirus vaccine candidate by February, according to a report.

“Dr. Paul Stoffels, Johnson & Johnson’s chief scientific officer, reportedly told Reuters that the company expects to have 60,000 people enrolled in a late-stage trial, dubbed ENSEMBLE, by year’s end.”

Inside Mexico’s Quest for a Homemade Vaccine. CNN reported:

“These are the trial runs of a COVID-19 vaccine production line in Mexico City, to which CNN was recently given exclusive access. The ampoules we saw were only filled with water. But if all goes to plan, officials hope to be producing millions of vaccine doses this way by the end of 2021.

“For Mexico, the development of its own vaccine is not just a matter of public health. While the first vaccines will be produced much earlier by some of the world’s richest countries, a nationally produced vaccine is Mexico’s failsafe — its best bet to ensure that if vaccine supplies from other countries prove difficult to obtain, its roughly 130 million citizens will still be protected.”

Nearly 1 Million Chinese People Have Received Drug Maker’s COVID-19 Vaccines. Wall Street Journal reported:

“Chinese authorities have inoculated nearly one million Chinese people with a COVID-19 vaccine from Sinopharm, though the state company has yet to provide solid clinical evidence of efficacy.”

COVID Vaccines Must Be ‘a Global, Public Good,’ WHO Says. CNBC reported:

“‘In the last few days we have received good news with two particularly promising vaccines. However, this promise will never be realized unless we ensure that all countries have access to the vaccine market, that it is delivered equitably, that it is effectively deployed and that countries address pockets of vaccine hesitancy,’ said Dr. Hans Kluge, WHO regional director for Europe.”

***

November 18, 2020

Food Stamps, Rent Assistance May Be Withheld From Those Who Refuse COVID-19 Vaccinations. Sandra Rose reported:

“Americans who refuse to get mandated COVID-19 vaccinations may lose benefits such as food stamps (WIC) and rent assistance, according to a document from Johns Hopkins Bloomberg School of Public Health’s Center for Health Security.

“According to the document, one of the top members of the “Working Group of Readying Populations for COVID-19 Vaccines” is Luciana Borio, MD, a prominent member of Joe Biden’s COVID-19 taskforce.”

Fauci Says 20 Million Americans Could Get Vaccinations Around the End of the Year. The Boston Globe reported:

“Dr. Anthony Fauci, the nation’s top infectious disease expert, said Tuesday that as many as 20 million people could get coronavirus vaccinations around the end of the year.

He said by that time there could be as many as 25 million doses of vaccine available from Pfizer and 15 million doses available from Moderna. The vaccination takes two shots so that would mean 20 million people could get protection.”

Pfizer’s COVID-19 Vaccine Just Came a Little Closer to Emergency Approval. Vox reported:

“But there are concerns as well. Pfizer and BioNTech’s latest announcement came, for the second time, in a press release instead of a peer-reviewed paper, although the companies revealed far more about the demographics of their clinical trial than in their first report. BNT162b2 also has some of the most stringent cold storage requirements, demanding temperatures of -70 degrees Celsius (-94 degrees Fahrenheit) or lower, which may make widespread distribution challenging. The vaccine is also administered in two doses spaced several weeks apart. That adds a huge logistical burden to rolling out the vaccine.”

Israel Health Ministry May Recommend Mandatory Coronavirus Vaccine Law. The Jerusalem Post reported:

“The move is meant to overcome hesitations by parts of the public against vaccinating. Many Israelis may not want to take the vaccination when it is first released.

“The team has expressed concerns in the past about Israelis not being willing to vaccinate and has recommended a number of steps, including increasing public education on the matter.”

Coronavirus Vaccine Shots Could Go to U.S. Health Workers in About a Month. CNBC reported:

“Health and Human Services Secretary Alex Azar told CNBC earlier this week that the FDA would move ‘as quickly as possible’ to clear both Pfizer and Moderna’s vaccine. The FDA process is expected to take a few weeks, and an advisory committee meeting to review the vaccine has been tentatively scheduled for early December.

“‘We will independently call those balls and strikes on the data and evidence, but we’re going to do so as quickly as possible, consistent with just making sure the science, the evidence and the law support authorization,’ Azar told CNBC’s “Squawk Box” on Monday.”

CureVac Deal Takes EU’s COVID Vaccine Supplies Close to Two Billion. Reuters reported:

 “The European Union has struck a deal for up 405 million doses of German biotech firm CureVac’s 5CV.DE potential COVID-19 vaccine, the head of the EU executive said on Monday, taking total supplies secured by the bloc to nearly 2 billion doses.

“The deal with CureVac follows EU supply agreements with AstraZeneca AZN.L, Johnson & Johnson JNJ.N, Sanofi SASY.PA, and Pfizer PFE.N for a combined 1.4 billion doses of their potential vaccines.”

***

November 17, 2020

Forced Vaccination Law in Denmark Abandoned After Public Protests.  Summit News reported:

“Last week we highlighted how both Ticketmaster and airline companies are considering barring people from entering venues and flying if they cannot prove they have taken the vaccine.

“So while public protests may be able to prevent authorities carrying out forced vaccinations, people who refuse to take the shot may find it virtually impossible to enjoy any kind of social life, use public transport, or even find employment.”

How a COVID-19 Vaccine Could End Up Helping the Virus Spread. Bloomberg reported:

“It’s also not yet clear how much protection the Pfizer-BioNTech vaccine and others would provide. The gold standard is to achieve sterilizing immunity, which is so strong that the virus can’t get a grip in the body at all — meaning that vaccinated people are safe to others. The human papillomavirus vaccine provides sterilizing immunity, for example. But sterilizing immunity is hard to achieve with viruses such as SARS-CoV-2, which  enter through the respiratory system. The only sure way to know if the vaccine provides sterilizing immunity would be to check whether trial subjects who remain free of Covid-19 have been exposed to it, by tracing their contacts.”

Pfizer to Start Pilot Delivery Program for Its COVID-19 Vaccine in Four States. Fox Business reported:

“‘We are hopeful that results from this vaccine delivery pilot will serve as the model for other U.S. states and international governments, as they prepare to implement effective COVID-19 vaccine programs,’ Pfizer said in a statement on Monday.

“It picked Rhode Island, Texas, New Mexico, and Tennessee for the program after taking into account their differences in overall size, diversity of populations, immunization infrastructure, and need to reach individuals in varied urban and rural settings.”

Pfizer’s COVID-19 Vaccine Distribution Will Be a ‘Logistical Nightmare.’ CBS News reported:

“Pfizer declined to offer specifics about the plan to distribute its vaccine. While the government is technically in charge of the overall vaccination effort, the company has opted to distribute its own vaccine. Pfizer has received $1.95 billion from the Operation Warp Speed to manufacture and distribute the first 100 million doses. The government will remain responsible for distributing syringes and other medical supplies needed for the vaccination effort.”

Novavax Posts Coronavirus Vaccine Contract That Government Didn’t Disclose. NPR reported:

“Notably, the Department of Health and Human Services told NPR in late August that it had “no records” of the Novavax contract in response to a public records request for it over the summer. The agency announced the deal July 7 to support development, manufacturing and the purchase of 100 million doses.

“Novavax released its federal contract in a quarterly financial filing with the Securities and Exchange Commission. HHS has yet to release this contract.”

It’s the ‘Vaccine Hesitant,’ Not Anti-Vaxxers, Who Are Troubling Public Health Experts. The Guardian reported:

“Only 7% would definitely refuse a COVID vaccine, according to a poll published last week by JL Partners. But around one in five are reluctant to some degree, with women more likely than men to believe it hasn’t been tested thoroughly enough. It’s these wobbling ‘vaccine hesitants’ who could most easily be swayed by something their friend puts on Facebook; who’d rather wait and see what happens when others have the jab.”

Encouraging Data From COVID-19 Vaccines Won’t Prevent a Dangerous Stretch of Rising Cases, Experts Warn. CNN reported:

“While the high efficacy rates coming out of the Moderna and the Pfizer/BioNTech vaccine trials are a good first step, a vaccine has yet to be approved and experts will also have to decide which groups should get vaccinated first.

An advisory committee to the U.S. Centers for Disease Control and Prevention is scheduled to meet next week to decided who will get the vaccine first, a longtime member of the committee said.”

COVID: Chemicals Found in Everyday Products Could Hinder Vaccine. The Guardian reported:

“Small amounts of per- and polyfluoroalkyl (or PFAS) chemicals are commonly found in the bodies of people in the U.S., as well as several other countries. These man-made chemicals, used in everything from non-stick pans to waterproof clothes to pizza boxes, have been linked to an elevated risk of liver damage, decreased fertility and even cancer.

“But scientists warn some of these chemicals can also cause another little-known but potentially significant defect by reducing the effectiveness of certain administered vaccines. This impediment could cast a shadow over efforts to roll out a COVID-19 vaccine to enough people that restrictions on day-to-day life are eased.”

What Does COVID-19 Vaccine Effectiveness Mean? Associated Press News reported:

“For both vaccines, the interim results were based on people who had COVID-19 symptoms that prompted a virus test. That means we don’t know yet whether someone who’s vaccinated might still get infected — even if they show no symptoms — and spread the virus.

“Also unknown is whether the shots will give lasting protection, or whether boosters will be required.”

Could mRNA COVID-19 Vaccines Be Dangerous in the Long-Term? The Jerusalem Post reported:

“An article published by the National Center for Biotechnology Information, a division of the National Institutes of Health, said other risks include the bio-distribution and persistence of the induced immunogen expression; possible development of auto-reactive antibodies; and toxic effects of any non-native nucleotides and delivery system components.”

***

November 13, 2020

States Ramping Up for Biggest Vaccination Effort in U.S. History. Associated Press reported:

“The push could begin as early as next month, when federal officials say the first vaccine may be authorized for emergency use and immediately deployed to high-risk groups, such as health care workers.

“‘The calvary is coming,’ Dr. Anthony Fauci said Thursday on ABC’s ‘Good Morning America.” He said he hopes shots will be available to all Americans in April, May and June.”

Bill And Melinda Gates Are Giving Another $70 Million For Covid Vaccines. Forbes reported:

“Of the newly promised $70 million, $50 million will go to the Covax Advance Market Committee of Gavi, the Vaccine Alliance; the committee is a financing mechanism through which Gavi works to secure equitable access to COVID-19 vaccines for 92 low- and middle-income countries. The donation will unlock an additional $16 million from the U.K. government, part of a commitment the country made to match some donations to the committee.”

HHS announces COVID-19 vaccine agreement with drug stores. Modern Healthcare reported:

“The goal eventually is to make getting a COVID-19 vaccine like getting a flu shot.

“Thursday’s agreement with major chain drug stores, grocery market pharmacies and other chains and networks covers about 3 in 5 pharmacies in all 50 states and U.S. territories such as Puerto Rico. It looks ahead to a time next spring when yet-to-be-approved vaccines will start to become available beyond priority groups such as health care workers and nursing home residents.”

Infected Again or Endless COVID? How the ‘Reinfection Phenomenon’ Could Impact Vaccines, Herd Immunity and Human Behavior. USA Today reported:

“No one knows how long the immune system can keep someone safe from COVID-19 after infection.

“Some diseases like measles are one and done. Once infected or vaccinated and the immune system typically provides protection forever. With other viruses, like the common cold — some of which are closely related to the coronavirus that causes COVID-19 — protection might not last a year, or even a season.”

How Pfizer Plans to Distribute Its Vaccine (It’s Complicated): Success will hinge on an untested network of governments, companies and health workers. New York Times reported:

“‘We have a lot of confusion at the state and the local health departments level, and a lot of concern about the nitty-gritty of deployment,’ said Dr. Saad B. Omer, the director of the Yale Institute for Global Health. ‘Which places, where to vaccinate, how to get the vaccine there, how to identify people in various risk groups, how to document, how to call back people for the second dose.’”

***

November 12, 2020

Boris Johnson to Meet Bill Gates to Plan National Vaccine Rollout With Pharma Giants. The Sun reported:

“A spokesperson for Downing Street said Mr. Gates, Mr. Johnson and bosses from pharmaceutical giants would discuss the [Prime Minister’s] ‘five point plan to stop future pandemics.’

“The plan was developed with the help of the Bill and Melinda Gates Foundation and the Trust, and aims to build a massive network of ‘zoonotic hubs’ to identify potentially dangerous viruses before they leap from animals to humans.”

Biden Coronavirus Task Force Doctor Says 4 to 6 Week Lockdown Could Control the Pandemic. Yahoo Finance reported:

“As the U.S. continues to set new daily record highs of coronavirus cases, at least one doctor on President-elect Joe Biden’s coronavirus task force is floating the idea of shutting down businesses in a lockdown that could last four to six weeks to control the spread of the pandemic.”

China Is Inoculating Thousands With Unapproved COVID-19 Vaccines. Why? NPR reported:

“One early November morning, a Peking duck cook, several construction workers and a software engineer patiently lined up outside a Beijing vaccine facility, awaiting their turn to be injected with a coronavirus vaccine still awaiting regulatory approval.”

Why COVID-19 Vaccine Policies Could Be Deadly for Older People, and the Age Discrimination Has Already Started. Marketwatch reported:

“‘When I read about the proposed ‘Fair Priority Model’ for allocating COVID-19 vaccines in Science magazine recently — from University of Pennsylvania medical ethicist Ezekiel Emanuel and 18 others — I realized that ageist policies might just kill older people like me.’”

Live Music Stocks Soar on COVID-19 Vaccine Breakthrough. Billboard reported:

“Companies related to live entertainment, travel and tourism have been especially battered in 2020. News of the vaccine has helped push these companies’ share prices multiples above their pandemic low marks: Live Nation now trades 212.4% above its 2020 low of $21.70; American Airlines share price is 55.4% above its 2020; and Hilton Worldwide is 132.4% above its pandemic low after a 11.1% bump on Monday morning.”

Fauci: Coronavirus Won’t Be a Pandemic For ‘a Lot Longer’ Thanks to Vaccines. The Hill reported:

“Anthony Fauci said Thursday the global coronavirus outbreak will not be a pandemic for ‘a lot longer’ because of the development of vaccines, striking a hopeful note even as the situation worsens in the short term.

“’Certainly it’s not going to be pandemic for a lot longer because I believe the vaccines are going to turn that around,’ Fauci said at an event hosted by the think tank Chatham House.”

Brazil Health Regulator Allows Resumption of China COVID Vaccine Trials. The Guardian reported:

“Brazil’s health regulator has allowed resumption of late-stage clinical trials for China’s Sinovac COVID-19 vaccine, which had been suspended due to a study subject’s death that was registered in Sao Paulo as a suicide.”

Moderna Hits COVID-19 Case Goal for Vaccine Candidate, Results Imminent. Boston Herald reported:

“The surge in coronavirus cases across Moderna vaccine trial sites in the U.S. will now allow the Cambridge-based company to complete the analysis of its mRNA vaccine candidate.

Coronavirus Vaccine: Eu Seals Deal With Biontech, Pfizer to Secure Doses. EIN News reported:

“The European Commission approved a contract with German pharmaceutical firm BioNTech and their U.S. partner Pfizer on Wednesday, guaranteeing that the bloc will receive millions of doses of their experimental coronavirus vaccine.

“After locking down the details of the deal on Tuesday, Commission President Ursula von der Leyen said the bloc hopes to ‘deploy it quickly, everywhere in Europe.’”

Who Will Make Coronavirus Vaccines for the Developing World? India Holds the Key. Washington Post reported:

“Wealthy countries have already grabbed a major chunk of the available supply. The U.S., the U.K., Japan and Canada have struck deals large enough to vaccinate their entire populations. By contrast, a pooled global effort to distribute vaccines equitably to more than 150 countries — including dozens of low-income nations — has secured only 700 million doses.”

CDC Thanksgiving Recommendations: Eat Outdoors, Limit Guests, Don’t Sing. CBS Boston reported:

The Centers for Disease Control and Prevention (CDC) points out celebrating virtually or keeping the meal to just members of your own household poses the lowest risk for spreading COVID-19.

***

November 11, 2020

Pfizer’s CEO Sold $5.6 Million in Stock on Same Day of Vaccine News. Axios reported:

“Pfizer CEO Albert Bourla sold $5.6 million worth of stock on Monday — the same day it said its and BioNTech’s coronavirus vaccine showed 90% effectiveness in preliminary results, which saw the company’s stock soaring almost 8%.

“The stock sale is perfectly legal through a predetermined plan called Rule 10b5-1, but the optics aren’t great. A Pfizer spokesperson did not add any new information in a statement [to Axios], saying the sale was part of a predetermined plan created in August.”

How COVID-19 Vaccine Can Destroy Your Immune System. Mercola.com reported:

“According to a study that examined how informed consent is given to COVID-19 vaccine trial participants, disclosure forms fail to inform volunteers that the vaccine might make them susceptible to more severe disease if they’re exposed to the virus.”

Eli Lilly Wins FDA’s Emergency Nod for COVID-19 Antibody — But, Thanks to Mixed Data, It’s Limited. Fierce Pharma reported:

“The FDA authorized Eli Lilly’s bamlanivimab for emergency use on Monday, making it the first antibody therapy to win that distinction. Dubbed LY-CoV555, it’s an anti-SARS-CoV-2 antibody therapy the Indianapolis pharma is co-developing with AbCellera.

“The OK comes with some caveats: It’s limited to patients 12 years and older who aren’t hospitalized but who are at high risk of developing severe illness, including elderly people and those with certain underlying conditions. And Lilly is advising infusion within 10 days of symptom onset.”

FDA requires Lilly to hire consultants to monitor quality control problems at plant making Covid-19 drug. Stat reported:

“The Food and Drug Administration is requiring Eli Lilly (LLY) to hire consultants to test batches and vet quality-testing data at a manufacturing plant where its COVID-19 antibody treatment is being made, a mandate that comes after the agency found quality control problems during two separate inspections over the past year.”

Pfizer, BioNTech Set for Billions in Yearly Sales as Fast COVID-19 Vaccine Launch Looms: Analysts. Fierce Pharma reported:

Pfizer’s early COVID-19 vaccine data have spurred intense hope about quashing the pandemic and lifted expectations for other vaccine programs in the works. And for the drug giant specifically, some analysts are predicting billions in sales for the shot for years to come.

“In a note to clients Tuesday, SVB Leerink analyst Geoffrey Porges said the results should ‘boost confidence of the general public in COVID vaccines, which should drive up the early adoption rate.’ The analysts see Pfizer’s vaccine snagging all of the early share of the market and generating $258 million in the fourth quarter of 2020.”

What Medical Experts Think About Pfizer’s New COVID-19 Vaccine. Huffington Post reported:

“Health experts agree these preliminary results are promising and exciting, but we still don’t have the full picture. We need much more data to understand which participants got sick and how severe their illness was. Researchers will also need to track the study participants in the months ahead to determine how the vaccine holds up over time.”

***

November 10, 2020

China Vaccine Trial Halted in Brazil After Serious Adverse Event. Bloomberg reported:

“The final-stage trial of a Chinese frontrunner vaccine candidate has been halted in Brazil due to a serious adverse event, the first time that any of the Asian nation’s rapidly developed COVID-19 shots have met with such a setback.

“Testing of Sinovac Biotech Ltd.’s vaccine, called Coronavac, has been halted in Brazil after an event that occurred on Oct. 29, said the Brazil Health Agency on Tuesday, without giving any further detail on what happened. The study is interrupted in accordance with regulations while the agency analyzes if the study should continue, it said.”

Pfizer Says Trials Show COVID Vaccine Is 90% Effective, But Questions Remain on Safety of Novel Technology. Children’s Health Defense reported:

“Pfizer CEO Albert Bourla told CNN the vaccine is ‘the greatest medical advance’ in the world’s last hundred years. He told ABC News that the drugmaker ‘feels very good about the safety.’

“But the New York Times cautioned that Pfizer’s data — delivered in a news release, not a peer-reviewed medical journal — ‘is not conclusive evidence that the vaccine is safe and effective, and the initial finding of more than 90 percent efficacy could change as the trial goes on.’”

HHS Secretary: Coronavirus ‘General Vaccination’ Programs by Spring. NBC News reported:

“Secretary of Health and Human Services Alex Azar predicted Tuesday that there would be enough COVID-19 vaccine for general public vaccination campaigns by spring 2021.”

U.S. Banks in Line for Windfall After COVID-19 Vaccine Progress. Financial Times reported:

“Stephen Scherr, Goldman Sachs’ chief financial officer, told a conference on Monday that the vaccine news ‘will be good for banks’ by giving rise to ‘reflationary outcomes’ and ‘more slope to the yield curve.’”

Oxford-Astrazeneca COVID-19 Vaccine Production Begins in Australia. Times Now News reported:

“Thirty million doses of the vaccine will enter manufacturing in Victoria on Monday, according to Sydney’s 2GB radio.

“’[The vaccine] is going to be voluntary but we will encourage as many people as possible,’ Health Minister Greg Hunt told 2GB on Monday. ‘We are confident that we will have a very high take-up amongst the Australian population,’” he added.”

Pfizer CEO Says He Would Take Coronavirus Vaccine First to Ease Public Concern. CNBC reported:

“Pfizer CEO Albert Bourla said Monday that he would like to be among the first to take a coronavirus vaccine to ease public concerns about vaccine safety.

“But there are ethical considerations for that, Bourla said during an interview on CNBC’s ‘Squawk Box.’ ‘If we have a limited number of doses, I’m not sure if people would recommend people of my age … or work capacity to be among the first to get a vaccine. So, I want to respect that.’”

Could a COVID Vaccine Bring Back Normality? The Guardian reported:

“England is back in lockdown. It happened not a moment too soon. As of 2 November almost three-quarters of a million new cases have been officially counted since 21 September, when the government’s scientific advisory committee Sage advised lockdown. On that day, Britain had only had about 360,000 cases since COVID-19 arrived. Now the figure is three times that. So many more cases mean it will take longer, and possibly require tougher social restrictions, to get numbers down by imposing lockdown than it would have in September, says James Naismith, head of the Rosalind Franklin Institute in Oxford.”

Pfizer Vaccine’s Funding Came From Berlin, Not Washington. Bloomberg reported:

“BioNTech is credited for contributing the messenger RNA technology, which prompts the body to make a key protein from the virus, creating an immune response. The biotechnology company already had a history of working with Pfizer on influenza vaccines, and in March they clinched a deal to co-develop a shot to prevent against COVID-19 at research sites both in the U.S. and Germany. The two companies began human testing of the vaccine in April, before the existence of Operation Warp Speed was revealed publicly.”

* * *

November 6, 2020

CDC Report: Officials Knew Coronavirus Test Was Flawed But Released It Anyway. NPR reported:

“One HHS official told NPR this shouldn’t have been a tough call. ‘The QC records showed that the test had a problem,’ the official said. ‘Lindstrom signed off on a quality control that was clearly flawed. He should not have released that kit.’”

CDC Seeks to Create a Centralized Reporting System for COVID-19 Test Results. Becker’s Hospital Review reported:

“CDC would like to partner with one or more organizations that have the infrastructure, capability, scalability, and safeguards to enable centralized public health laboratory data reporting from testing entities to state and large local health departments, with a focus on multi-state, large regional, and state-wide reporting entities.”

First COVID-19 Vaccine Doses to Go to Health Workers, Say CDC Advisers. NPR reported:

“Healthcare workers will almost certainly get the first doses of COVID-19 vaccine in the U.S. when one is approved, according to Dr. José Romero, head of the committee that develops evidence-based immunization guidelines for the Centers for Disease Control and Prevention.”

* * * 

November 5, 2020

Cincinnati Children’s Seeks Volunteers for COVID-19 Vaccine Trial. Local 12 reported: 

“Cincinnati Children’s is seeking volunteers for its AstraZeneca COVID-19 vaccine trial.

“The center is specifically reaching out to people who are black and Hispanic as well as seniors and first responders.”

Gilead Won Valuable FDA Voucher With Its Veklury Approval, but Patient Advocates Are Urging Company to Give It Up. Fierce Pharma reported:

“Public Citizen’s [Peter] Maybarduk called on Gilead to ‘relinquish’ the voucher, arguing that taxpayers have contributed more than $70 million toward Veklury’s development. Plus, Gilead is already benefiting from Veklury sales, he argued. In the third quarter, the drug raked in $873 million, and analysts figure the medicine is on track to post another $650 million to $950 million during the fourth quarter.”

COVID-19 Vaccine Rollout to Feature App Tracking, Monitoring of Vulnerable Groups. The Wall Street Journal reported:

“Government health officials and drugmakers plan to roll out extra tools to detect whether COVID-19 vaccines cause any serious side effects once the shots are cleared for widespread use, aiming to fill gaps in existing safeguards given the expected speed and scope of the rollout.”

Pfizer Sidelines U.S. Government in COVID-19 Vaccine Distribution Strategy. Fierce Pharma reported:

“Pfizer is under pressure from all sides to make its COVID vaccine rollout a success. With interim data from a phase 3 trial yet to come, the company already has a $1.95 billion deal with the U.S. government to supply up to 100 million doses of its candidate vaccine, BNT162b2. Pfizer has vowed to distribute 40 million of those doses before the end of the year.”

Brazil Allows Johnson & Johnson to Resume Trial of COVID-19 Vaccine. Reuters reported: 

“Brazilian health regulator Anvisa has authorized resumption of a clinical trial of Johnson & Johnson’s experimental COVID-19 vaccine, according to a statement from the government agency on Tuesday.

“The J&J vaccine is one of four being tested in Brazil, which has the world’s third worst outbreak behind the United States and India, and the second-highest COVID-19 death toll.”

The FDA’s Cutoff for COVID-19 Vaccine Effectiveness is 50 percent. What does that mean? NBC News reported:

“Over the summer, the Food and Drug Administration announced that in order for an experimental COVID-19 vaccine to get the green light, it would need to be safe and ‘prevent disease or decrease its severity in at least 50 percent of people who are vaccinated.’”

Challenges in Creating Herd Immunity to Sars-cov-2 Infection by Mass Vaccination. The Lancet reported:

“Vaccines to protect against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) have risen up the agenda of most policy makers and individuals as the second wave of COVID-19 in northern hemisphere countries grows and there is increasing pressure on health-care systems.”

AstraZeneca Expects COVID-19 Vaccine Trial Results This Year. The Wall Street Journal reported:

“AstraZeneca PLC said late-stage trials for the COVID-19 vaccine it is developing with the University of Oxford are on track to produce results “later this year,” with a potential rollout soon after, subject to regulatory approval.”

England Puts Doctors on Alert for Covid Vaccine Before Christmas. Bloomberg reported:

“Simon Stevens, chief executive of the National Health Service in England, told the BBC on Wednesday that with more than 200 COVID-19 vaccines in development, one will “hopefully” be available in the first part of next year, but doctors will be “gearing up” in case it is ready sooner.

“The U.K.’s drug regulator has started accelerated reviews of vaccines under development by Pfizer Inc. and AstraZeneca Plc, as Britain gets ready to approve the first successful shot as quickly as possible.”

***

November 3, 2020

3 Maine Students Given Flu Shots at School Without Parental Consent. USA Today reported:

“Three students received flu shots at school, even though their parents had not consented to the vaccinations, a spokesperson for the healthcare organization that administered the shots confirmed.”

FDA Whitewashes Warnings About Coronavirus Vaccine Trials. Project on Government Oversight reported:

“During the meeting, members of the committee explained several reasons to worry about the clinical trials now underway to test potential coronavirus vaccines and how the FDA review process could unfold.

“Some of the concerns related to the potential for the FDA to issue emergency use authorizations for experimental vaccines. Such orders would allow distribution of vaccines before they qualify for formal approval.”

Cuomo Questions CDC Plan to Require ID for COVID-19 Vaccination. The Buffalo News Reported:

“The governor said the agency would require states to provide to the CDC personal information about each person who gets vaccinated — including an ID number.”

The FDA’s Cutoff for COVID-19 Vaccine Effectiveness is 50 percent. What Does That Mean? NBC News reported:

“Based on the effectiveness threshold the FDA has set for a COVID-19 vaccine to be approved or granted emergency use authorization, it’s possible a vaccine becomes available that helps only half of people receiving it, while offering no benefit to the other half. It’s also possible that a vaccine could have different effects in different people — helping to prevent disease in some people while reducing the severity of COVID-19 in others.”

COVID-19 Vaccine Mandates at Work Promise Employer Headaches. Bloomberg reported:

“Employers that want their workers to take a COVID-19 vaccine once it’s available would be better off encouraging and facilitating its use, rather than requiring it as a condition of employment, according to legal and public health observers.”

Drug Company Insiders Are Profiting Handsomely from the World’s Desperate Hope for a COVID-19 vaccine. The Boston Globe reported:

“‘These drug companies have a great scheme going,’ said Eli Zupnick, a spokesman for Accountable.US, a progressive group in Washington, D.C., that says it is committed to exposing corruption. ‘Taxpayers cover the upfront investment costs and shoulder any downside, while their executives and shareholders can capture the upside if their drugs pan out and are shoveling obscene amounts of money into their pockets throughout the process.’”

In Boost to CVS and Walgreens, U.S. Expands COVID-19 Vaccination Powers to Pharmacy Techs. Forbes reported:

“Pharmacy technicians will join their pharmacist colleagues in the effort to quickly immunize Americans against the Coronavirus once a vaccine against COVID-19 is approved by the U.S. government, perhaps by the end of the year.”

Protests in Brazil Support President in Anti-Vaccine Stance. The Star-Tribune reported:

“PoderData poll said this week the percentage of Brazilians who say they would take a coronavirus vaccine dropped to 63% in October from 85% four months earlier. The percentage rejecting the idea of taking a vaccine rose to 22% from 8% in July.”

Scientists Warn Americans Are Expecting Too Much From a Vaccine. Connecticut Mirror reported:

“The White House and many Americans have pinned their hopes for defeating the COVID-19 pandemic on a vaccine being developed at “warp speed.” But some scientific experts warn they’re all expecting too much, too soon.”

Britain Starts Accelerated Review for AstraZeneca’s Potential COVID-19 Vaccine. Reuters reported:

“AstraZeneca and Pfizer are among the frontrunners in the race to develop a vaccine for the coronavirus, with the race also including Johnson & Johnson and Moderna Inc. Their vaccine candidates are in late-stage trials, interim data from which are expected in the coming weeks.”

Government Minister Admits Vaccine That Crushes COVID ‘May Never Materialize.’ DevonLive reported:

“Business Secretary Alok Sharma promised a ‘steady but significant’ deployment of rapid coronavirus tests as he acknowledged a vaccine which can eradicate COVID-19 ‘may never materialize.’”

***

October 30, 2020

Professors Demand Transparency in COVID-19 Vaccine Trials. Yale Daily News reported:

“Five Yale law, medicine and public health professors, along with a national team of scientists, signed an open letter last week addressed to U.S. Secretary of Health and Human Services Alex Azar LAW ’91 calling for greater transparency in COVID-19 vaccine clinical trials.”

Black Americans Are the Most Hesitant to Get a COVID Vaccine. USA Today reported:

“Black Americans distrust the government so much they’re not participating in large numbers in COVID-19 clinical trials, and many say they won’t get a COVID-19 vaccine — at least not until many others get it.

States Say They Lack Federal Funds to Distribute Coronavirus Vaccine as CDC Tells Them to Be Ready by Nov. 15. The Washington Post reported:

“State health officials are expressing frustration about a lack of federal financial support as they face orders to prepare to receive and distribute the first doses of a coronavirus vaccine by Nov. 15, even though one is not likely to be approved until later this year. The officials say they don’t have enough money to pay for the enormous and complicated undertaking.”

Already, Pharmaceutical Companies’ Predictions About COVID-19 Vaccines Haven’t Come True. CNN reported:

“Dr. Paul Offit, a member of the U.S. Food and Drug Administration vaccine advisory committee, said pharmaceutical companies would be wise to stop making forecasts about their timelines.

“‘Companies should stop making predictions, because nature is very humbling,’ Offit said.”

No-fault Compensation for Vaccine Injury — the Other Side of Equitable Access to COVID-19 Vaccines. The New England Journal of Medicine reported:

“Wealthy governments that have invested in vaccine candidates have made bilateral agreements with developers that could result in vaccine doses being reserved for the highest-income countries — a phenomenon known as ‘vaccine nationalism’ — potentially leaving people in poor countries vulnerable to COVID-19.

COVID-19 Vaccine Won’t Be Available Until January, Fauci Says. Bloomberg reported:

“President Donald Trump, pharmaceutical industry leaders and some public-health officials had said previously that an immunization to prevent COVID-19 could be available before the Nov. 3 election. That date has been consistently pushed back, however, as clinical studies — which are running at unprecedented speed — started to hit a few hurdles.

Federal Government Says it Will Pay for Any Future Coronavirus Vaccine for All Americans. CNN reported: 

“The Centers for Medicare and Medicaid Services said it will pay for any COVID-19 vaccine that is authorized or approved by the U.S. Food and Drug Administration to allow for “broad vaccine access and coverage for all Americans.

“The agency also announced it will help cover a larger portion of the cost of new COVID-19 treatments that may be coming down the pipeline for Medicare recipients.”

Meet the Youngest Participants in COVID-19 Vaccine Trials: Teens and Tweens. NBC reported:

“Earlier this month, Pfizer became the first pharmaceutical company in the United States to receive approval from the Food and Drug Administration to test its vaccine on children as young as 12.”

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