On Wednesday, August 31, the FDA issued emergency use authorizations
for new Pfizer and Moderna mRNA booster vaccines for COVID. The next
day, September 1, the CDC's advisory committee and CDC Director approved
the immediate rollout of the new vaccines. They will be administered in
the US starting this week.
Fastest Vaccine Rollout in World History
Surprisingly, more than a month before either agency had given its okay to the entirely new formulation, the federal government ordered 105 million doses from Pfizer and 66 million doses from Moderna.
The desired composition of the vaccine had only been formally
determined by FDA after its advisory committee had met on June 24, 2022.
The vaccines contain a mix of the old, original Wuhan strain vaccine
mRNA (now also referred to as the ancestral vaccine) and a new omicron
BA.4/5 mRNA coding for the omicron spike protein.
The total amount of mRNA for the Pfizer and Moderna booster vaccines
is the same as before: 30 mcg for Pfizer and 50 mcg for Moderna. Each is
composed of 50% omicron mRNA and 50% ancestral mRNA, and they are
termed bivalent vaccines.
The new vials and their boxes do not list the dose, hinting that the
decision regarding how much to use was made very recently. Even the
members of the CDC's advisory committee did not know the dosage of the
new bivalent vaccines until their September 1 meeting.
This is the fastest rollout of a new vaccine in world history. How
did it happen? Instead of this being a tale of human grit and ingenuity,
it is a tale of human weakness and recklessness. Let me ask again: how
did such a rapid vaccine rollout occur?
It occurred the only way it could
possibly occur: by bending the rules, creating a new regulatory playbook
and failing to obtain any human data for the new vaccines. The
manufacturers did not have to go through months-long trials, and FDA did
not have to pore over any human trial data, because there weren't any.
Let that sink in: the new BA.4/5 bivalent vaccines have only been tested
in mice, not humans.
Unexpected International Coordination
Here is an amazing fact: On the same day that the CDC gave its
approval to start the vaccine program, September 1, health agencies in
Canada, Switzerland and the European Union's FDA (the European Medicines
Association) also rolled out new, bivalent booster shot programs. Almost simultaneously, the UK authorized 2 different bivalent boosters on August 15 and September 3.
The UK has told people to expect the largest rollout in history for
the new bivalent boosters. And it has started the program by promising large bonuses to doctors if they manage to vaccinate every single resident of a nursing home by October 23.
These other countries are using an earlier omicron mRNA as the
template for their omicron-ancestral bivalent vaccines, while the US is
using the mRNA code for the later omicron variant BA.4/5 spike.
How Can You Get Complete Information on These Boosters?
How are the mainstream media telling this story? With their usual
spin, avoiding the sticky parts. Instead of helping you understand what
just happened, the New York Times asks,
"When should you get yours?" Not should you get it, just when should
you get it. The Herald Tribune tells you why you should get it.
STAT News says
it answers your questions, but it never asks the relevant questions
about why such a rapid, unprecedented rollout occurred — especially when
we are at practically historic lows for deaths and ICU stays due to COVID.
The Associated Press did slightly better, at least posing the question of whether you should get a new booster. But then its answers don't dig any deeper than its fellow media outlets.
It looks like you won't be getting the information you need to
understand the boosters and the process by which they were ushered in
from the major media.
So the Defender has reviewed FDA documents, attended the all day CDC advisory committee meeting on September 1, studied a review of the boosters published in the New England Journal of Medicine on August 31, and evaluated a study
of omicron boosters that were tested in non-human primates by Dr.
Fauci's Vaccine Research Center. We will provide you real science.
What Did FDA Say About Its Emergency Use Authorization for the New Boosters?
FDA did not convene its advisory committee before issuing the
authorizations, and it is not hard to guess why. Last year, its advisors
voted against
authorizing the ancestral boosters, because the data they were given
indicated the old vaccines were continuing to work well. Two top
officials at FDA who disagreed with the 2021 booster rollout resigned, hinting that the decision to issue boosters had been imposed on the FDA.
This year, FDA's VRBPAC (Vaccine and Related Biological Products
Advisory Committee) members have been complaining about being given less
and less data as they are asked to sign off on vaccine programs for
younger and younger ages.
VRBPAC member Dr. Paul Offit, a professor of pediatric infectious
diseases at the University of Pennsylvania and coinventor of a Rotavirus
vaccine said
last month that "the fix was in," implying that the committee's
deliberations were a sham, because the White House announced it was
purchasing the vaccine right after the meeting ended.
Dr. Offit was quoted last week as saying the mouse data were not
sufficient to roll out the new boosters. So FDA chose not to give him
and the other members a public venue where they would predictably
complain about FDA's laxity — what some might call recklessness,
insubordination or even gross malfeasance.
After all, according to the FDA's mission statement,
FDA "is responsible for protecting the public health by ensuring the
safety, efficacy, and security of human and veterinary drugs, biological
products, and medical devices." Not rubberstamping untested vaccines.
The FDA justified its authorizations using language that was probably intended to confuse the public. Here are several examples.
1. Everyone knows the term "safe and
effective," which is an official FDA stamp of approval for licensed
drugs and vaccines. However, by law the term cannot be used by FDA to
refer to unlicensed, experimental products, which is what all emergency
use authorized drugs and vaccines are. So FDA tried to hint at the
desired terminology without using it.
In its press release
on the new boosters, FDA used almost, but not quite identical
terminology, quoting Dr. Peter Marks, the director of FDA's vaccine
center: "We have worked closely with the vaccine manufacturers to ensure
the development of these updated boosters was done safely and
efficiently."
2. Dr. Marks also said, "The public can
be assured that a great deal of care has been taken by the FDA to ensure
that these bivalent COVID-19 vaccines meet our rigorous safety,
effectiveness and manufacturing quality standards for emergency use
authorization." Again, 'safe and effective' is implied but not exactly
stated.
3. What Dr. Marks expects the public to
miss is the fact that there are no quality standards for emergency use
authorizations (EUAs). The statute
authorizing EUAs simply requires that the known and expected benefits
outweigh the known and expected risks of the product. There are no
quality requirements at all, and FDA is not even required to inspect the
factories where EUA products are manufactured, as it must do for
licensed products.
Nor is it required to inspect the final product. So the FDA is
fooling us when it claims the standards are rigorous. Furthermore, Dr.
Marks and the FDA know that all EUA products have been granted an
extremely broad waiver of liability that covers Dr. Marks, the FDA, CDC,
HHS, the manufacturers, distributors, doctors, pharmacists, and
everyone involved in the vaccine program.
So they can tell us anything, because the public has no recourse to the courts to bring suit when an EUA product is involved.
4. FDA justifies its assessment that the
untested vaccines are safe using the following argument: "The safety
data accrued with the bivalent vaccine (original and omicron BA.1) and
with the monovalent Moderna COVID-19 Vaccine are relevant to the Moderna
COVID-19 Vaccine, Bivalent because these vaccines are manufactured
using the same process."
This is the same as claiming that almond butter is safe, so peanut
butter is safe too because it is manufactured using the same process. Is
that really the best excuse for failing to perform its regulatory
functions that FDA can offer?
What Happened at the CDC ACIP (Advisory Committee on Immunization Practices) Meeting on September 1?
CDC knew that it would have a hard time convincing the public to take
these vaccines, since almost everyone has already had COVID, the
earlier vaccine benefits were overpromised, the disease has become
milder, the vaccines do not prevent infection or transmission and the
fearfulness around COVID is mostly gone. Therefore, CDC needed to employ
new strategies.
One strategy was to invoke the 'bandwagon effect.' You try to
convince the public that everyone else is getting the shot, so they too
should jump on the bandwagon. A poll was presented at the ACIP meeting
that claimed that 72% of people that were eligible planned to get the
new boosters.
How likely is that to be true? Only 33% of the population has already
gotten a first booster, while 65% have said, 'No thanks.' And the
interest in COVID jabs is way down. Under 5% of preschoolers have received a COVID vaccine in the 3 months since they were authorized.
CDC implied to the ACIP that 49% of the public had been boosted, while its own statistics in the NY Times
say the actual number is 33%. Here is how CDC performed the calculation
to make it appear the boosters are more popular than they are:
sixty-seven per cent of the public is 'fully vaccinated' according to
the CDC. Forty-nine percent of those 67% (those who are fully
vaccinated) is 33%.
The federal government allocated a billion dollars
to buy advertising and guarantee positive news coverage (and suppress
bad news) to push the earlier COVID vaccines. One wonders how much will
be spent to push the new boosters.
CDC says that 224 million Americans are 'fully vaccinated.' The ACIP
members were told that of this number, 210 million are already eligible
for the new boosters. The government has bought 171 million bivalent
booster doses so far (105 million from Pfizer and 66 million from
Moderna) which can be used for those aged 12 and up.
FDA and CDC have yet to allow the rollout of new bivalent boosters
for children under twelve, who have in the past received lower dose
COVID vaccines than adults. But the agencies said they plan to do so
within weeks.
Another testy issue for the ACIP committee was the question of how
long these boosters will work, and how frequently they will be
recommended. The ACIP members are responsible for giving advice on all
vaccines, and they don't want the COVID vaccines to sour the public on
other vaccines.
Although a recommendation to give the bivalent boosters 4 months
after an earlier dose had once been floated, the ACIP committee was
asked to approve the boosters when at least 2 months had passed since a
prior dose. CDC's Dr. Twentyman said that CDC is no longer counting the
total number of doses. She said that even if a person has received 4 or 5
prior COVID vaccinations, a new bivalent booster "should not be
denied," as long as 2 months have passed since the last dose.
How Long Will It Work?
According to this week's NEJM article,
"increased neutralizing antibody titers, as well as clinical effectiveness, have been shown to wane by four months after a third messenger RNA immunization. After a fourth messenger RNA immunization, protection against infection with SARS-CoV-2 omicron has been reported to wane after just 4 weeks, although protection against severe disease lasts longer.
Hybrid immunity from both vaccination and infection provides greater and more durable protection than either alone."
Four weeks! Antibody titers sink 4 weeks after the 4th dose. No
wonder CDC is allowing, and may encourage, such frequent boosters.
The COVID vaccinators have coined a new term, hybrid immunity,
riffing off hybrid electric cars. It refers to the improved immunity a
vaccinated person has if they also got the disease! As if being
vaccinated but getting the disease anyway is to be normalized as
desirable. After CDC spent two years denying that natural immunity — the
kind people get after infection — even exists, CDC is now trying to
take a lemon vaccine, add natural immunity, call it hybrid immunity and
make lemonade!
How Was This Rollout Justified?
Omicron variants have been present since last November, and it was
soon discovered that both vaccine-induced and natural immunity due to
earlier variants were very limited for omicron variants, because they
are so different from the ancestral strain. The health agencies and
manufacturers have been testing omicron vaccine prototypes for up to 9
months.
Most of those tests involved BA.1 and BA.2 omicron strains. However,
90% of current cases are caused by omicron BA.5, which is genetically
far from BA.1 and BA.2.
But there was some human data (involving a few hundred subjects each)
for several of the earlier omicron vaccine prototypes, so the health
agencies decided to simply pretend that mRNA designed for BA.1 and BA.2
was close enough to BA.5 that the data were comparable.
Since 50% of the vaccine contents would be the old vaccine, FDA
claimed it had already established the safety and efficacy of that half.
Then, to round things out, there were data from mice, which generated
comparable antibody levels to the new vaccines as they had to older
vaccines. And of course, we can rely on mice to behave exactly like
people, right? After all, they have been 'humanized' to contain a human
ACE-2 receptor.
No, we cannot rely on mice. We cannot even rely on nonhuman primates
as a model for vaccines, as every species reacts uniquely and
unpredictably to infections and to vaccinations. But mice data do bulk
up FDA's authorization 'package' so it looks like FDA did a more
thorough review.
Having Discussed How Long This Booster Might Last, One Needs to Ask How Well It Might Work
Predictions from Nature
magazine and Dr. Fauci's NIAID Vaccine Research Center (VRC) at the NIH
are that the new vaccines will not improve on the old vaccines.
According
to the VRC, "a study in nonhuman primates showed that an omicron
specific messenger RNA vaccine was not better than the original
messenger RNA-1273 [ancestral Moderna] vaccine for protection against
omicron challenge."
Nature
notes, "an analysis [posted August 26] suggests that updated boosters
seem to offer much the same protection as an extra dose of the older
vaccines — particularly when it comes to keeping people out of
hospital."
Neither of these studies was discussed at the ACIP meeting. No
discussion was provided regarding why and how the bivalent vaccines were
chosen.
The reason why the omicron vaccines won't stimulate a good omicron
response is attributed by the NIAID VRC authors to antigenic priming,
also known as original antigenic sin. This means that the immune system
has been programmed to respond over and over again to the first
coronavirus infection or vaccine it encountered, even when it encounters
different coronavirus antigens later.
How well did the old vaccine work? The CDC slide below, presented by
CDC's Dr. Link-Gelles, is not well labeled, but it shows that whether
you got two or three doses of the old vaccine, during the omicron period
efficacy in all age groups was under 40% at three months. By six months it hovered around zero efficacy (no benefit), and after that it was negative (harmful) for most ages.
Negative efficacy means that the vaccinated are more prone to being
infected with COVID than the unvaccinated. This is consistent with what
we are seeing from the UK and some other countries: the vaccinated
become more likely to get COVID. And it is this effect that the public
health agencies are probably trying to stave off, or hide, with
perpetual boosters.
It appears the public here and in many other countries is being
misled to receive an untested (or in other countries a BA. 1 or 2
minimally tested) shot on the false promise it will be so much better
than the older vaccine. The regulators know it is unlikely to be better,
but their public relations engines are revved up to convince us
otherwise.
How Safe Are the New Vaccines?
That is anybody's guess, because you cannot assess human safety from
animal models, since they don't predict the human response. What was
done to evaluate the safety of the bivalent vaccines?
Reactogenicity
Reactogenicity is a word that refers to short term vaccine adverse
reactions, like fever, redness, fatigue or muscle aches. According to
the CDC briefers, the degree of reactogenicity from the omicron
prototype vaccines was comparable to that from the older, 'ancestral'
COVID vaccines.
There were no data on more serious side effects, and Dr. Shimabukuro
of CDC said there was no way to assess the risk of myocarditis due to
the small number of subjects who received the prototype vaccines.
However, if you look at Pfizer's chart
prepared for the ACIP members below, you will notice that there was
greater reactogenicity (more acute side effects) seen after the omicron
prototype vaccines than seen after the older vaccines. This may be a
signal that more severe reactions will result from the newer vaccines,
but there is no way to be sure.
Myocarditis
Presenters to the ACIP claimed that myocarditis was less common after
booster shots of the old vaccine than after the second dose of the
initial series. However, slide 39
shown by Dr. Shimabukuro, which was quickly passed over, showed the
opposite. For 16-17 year-old boys and girls, and for men aged 30-39, the
chance of myocarditis was increased after a booster. (See below.)
So there is no reason to think the boosters will be any safer than
the second dose, in terms of myocarditis. That risk, by the way, was
about 1 in 2,000 young men aged 18-24 after their second dose in one
Kaiser study.
Dr. Shimabukuro also said that if you get vaccinated soon after
recovering from COVID, increased side effects, at least short-term, are
to be expected — but "there is a lack of evidence that it places you at
increased risk of myocarditis." I am not reassured by the lack of
evidence. In fact, pediatric cardiologist Dr. Kirk Milhoan last week reviewed all the evidence that Dr. Shimabukuro couldn't find.
Getting vaccinated soon after recovering from COVID is foolhardy, and
any officials mandating the shots after recovery are putting those in
their charge at even greater risk of adverse reactions, including
myocarditis.
Some scientists, including Dr. Barouch in last week's NEJM, assert
that myocarditis is "far more frequent" after a case of COVID than it
is after vaccination. But he cited not a single source for this claim.
Pediatric cardiologist Kirk Milhoan reviewed
all the recent literature on the question of myocarditis rates after
infection versus after vaccination. It appears that the vaccine puts you
at more risk of myocarditis than a COVID infection does, but there are
many different factors that influence risk, including age, gender,
whether you already had COVID and how recently, and the type of vaccines
received.
Moderna vaccines are more likely to cause myocarditis than Pfizer. Receiving a Moderna vaccine after an initial Pfizer vaccine raises the risk even more than getting 2 Moderna vaccines. See Table 2 from an important study of myocarditis in 4 Nordic countries.
France, Germany, Sweden, Norway, Finland, Denmark and Iceland have all halted Moderna COVID vaccinations for young males.
An ACIP member asked whether the Jynneos monkeypox vaccine, which can
also induce myocarditis, could be given together with the new bivalent
vaccines? Would this increase the myocarditis risk? The surprising
response was, "Read the briefing book," which may have meant that this
was not to be discussed in public.
Speaking of what could be discussed in public, any discussion of
pregnancy and COVID vaccination was forbidden at the ACIP meeting.
Multiple committee members asked for information on pregnancy, but the
briefers steadfastly refused to provide any. Nothing on
hospitalizations, deaths, fetal outcomes.
The ACIP members were told they would be briefed on this at a future
meeting. Dr. Miller, representing Moderna, said they were in the process
of enrolling a total of 800 pregnant women in a study. Which would
someday be completed. The only conclusion I can draw is that the CDC
doesn't like the results they have now. And they plan to delay providing
them to the public for as long as possible.
Yet CDC established a pregnancy registry
for the COVID vaccines nearly 18 months ago. CDC and FDA must have data
on many thousands of pregnancies. Every woman who receives a COVID
vaccine dose must provide information on whether she is pregnant before
she can be vaccinated, and CDC collects all this information.
Furthermore, there are thousands of VAERS reports on adverse pregnancy
outcomes.
FDA required
Pfizer/BioNTech to study the effect of the vaccine in pregnancy when it
issued a license for Comirnaty on August 23, 2021. FDA also required
additional vaccine safety studies in children and additional studies of
myocarditis at the same time. The problem is that these studies won't be
completed for up to five years, long after billions of doses have been
given and the vaccines will be long out of date.
It is difficult to justify why FDA would ask for these studies to
take so long. Was FDA requesting such long study durations in order to
delay its vaccine safety assessment until after the vaccines are no
longer in use?
The only conclusion I can draw is that FDA and CDC don't like the
safety results they already have. And they plan to withhold the bad news
for as long as possible.
Long COVID
The committee was also interested in long COVID. Might the vaccines
prevent this dread complication? CDC was mum. The CDC briefer claimed
that CDC does not have "systematic data" on long COVID. Nor has CDC
developed a case definition for long COVID. Why has CDC delayed
investigating this critically important complication?
The NY Times revealed
in February 2022 that CDC conceals the bulk of the public health data
it collects. According to the Times, "Much of the withheld information
could help state and local health officials better target their efforts
to bring the virus under control."
You are not going to find a more public indictment from the NY Times of our Centers for Disease Control than that.
Does vaccination fail to prevent long covid? Does it cause long
covid? FLCCC founder and esteemed intensive care physician Dr. Paul
Marik has postulated that both long COVID and many COVID vaccine
injuries are due to the same thing: the prolonged presence of spike
proteins in the circulation.
If true, there may be considerable overlap between the symptoms and
pathology of long COVID and vaccine injuries, and CDC may be trying to
conceal this, or perhaps be seeking a way to claim that all the vaccine
injuries are due to COVID.
FDA Revoked All Pfizer and Moderna Emergency Use Authorizations for the Old Boosters on August 31
This was sudden and unexpected. Appointments had to be cancelled,
because starting on August 31 the old vaccines were limited to use in
only young children or for the initial series. The FDA did not withdraw
or recall the licensed Comirnaty and Spikevax vaccines, which have also
been approved as a booster dose. Is this a tacit acknowledgement that
there is no licensed Comirnaty or Spikevax available in the US?
Might the FDA have rolled out the new vaccines so quickly to justify
removing most of the old vaccines from use, soon after reports began
circulating about their contents containing undisclosed and possibly
harmful materials?
Conclusions
- The FDA and CDC have cooperated to issue emergency use
authorizations and rollout new, bivalent Pfizer and Moderna COVID
vaccines this week, without any human trials, which is unprecedented.
- These vaccines continue to enjoy extraordinary protection from
liability, while the recipient has no access to the legal system in the
case of injury.
- There is no evidence that the new vaccines are safe, while there is
limited evidence that they may be more harmful than earlier COVID
vaccines — but in the absence of human testing, there is no way to truly
predict their safety. Safety data are being concealed by the federal
health agencies. Messaging by them is misleading.
- There is no evidence the new bivalent vaccines will be more
effective than the older vaccines, and existing evidence suggests that
any efficacy they provide will persist no longer than 1 to several
months.
- COVID vaccines appear to increase susceptibility to COVID infections, on average starting 6 months after an inoculation.
- Perpetual boosters briefly stave off the negative efficacy that
develops a few months after a COVID vaccination. This may be why
frequent boosters are being pushed. But frequent boosters may also weaken overall immunity and may even contribute to rising mortality rates in the US and UK.
- There is international coordination regarding bivalent boosters, and
a major effort will be undertaken to get them into arms, despite
historically low levels of severe COVID. Why?
No comments:
Post a Comment