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.”