Friday, September 24, 2021

Nutshell version of the boosters, FDA and CDC

Back in June and July, I told you about the charade going on in the media and at CDC to make Americans think a decision on booster doses would be made based only on the Science. Supposedly our public health agencies were pushing back against Pfizer. Below I explain how the charade finally played out.

1.  Marion Gruber, the #2 person in CBER, who has been there for decades and her deputy, Phil Krause, announced their resignations in August, just after Biden administration announces its plan to offer third vaccine doses beginning the week of September 20. Both FDA's Acting Commissioner and CDC's Director signed off on [the] White House announcement in August.

2.  FDA issued a license for the Pfizer vaccine on Aug 23, for only two doses, while permitting a third dose only for those who are immunocompromised.  FDA failed to hold an advisory committee meeting around this decision.

3.  FDA is caught out for a "bait and switch": licensing Comirnaty when only the EUA vaccine, named Pfizer-BioNTech, is actually available in clinics.  The "license" provides legal cover for mandates, while the EUA provides broad liability cover to the manufacturer. I was the first person to publicly identify this fraud.

4.  FDA schedules an advisory committee meeting for Sept. 17, the Friday before Biden's Sept. 20 date to start offering boosters to the public.

5.  Gruber and Krause publish an article in the Lancet noting boosters are not necessary.

6.  Pfizer presents to the FDA vaccine advisory committee a very small and inadequate data collection to justify the requested broad license expansion for boosters, almost as if they don't want it.  Or perhaps they were told it would be a shoe-in.  Israeli data are presented to buttress the argument for boosters.  The advisory committee votes against the broad expansion of boosters to the general population, 16-2.  And this is a hand-picked committee, most of whom are temporary members, chosen, it seems, to help usher in the shots with the least difficulty.

7.  A new question is quickly created and put to the advisory committee, asking whether they will approve boosters for those over 65 and those at high risk of severe disease.  They give a unanimous vote yes.

8.  FDA leadership has the right to make decisions that go against the advisory committees, but there is a political and prestige cost when this is done. On Wednesday evening 9/22/21, just before the CDC's advisory committee, the ACIP (Advisory Committee on Immunization Practices) was to vote on which demographics would get a recommendation for a booster dose, the FDA announced its decision to go against its advisory committee and, with weasel words I explained yesterday, opened the booster dose to a broad swathe of Americans.  However, the FDA did not license the vaccine for this; instead, FDA expanded the EUA.

6.  On 9/23/21 the ACIP committee met, were briefed, and were posed 4 questions to vote on.  They assented to 3, but, like the FDA advisory committee, refused to approve a recommendation for a broad expansion of the third dose. (It should be noted that all members of both advisory committees work at medical schools, where a third dose would probably become mandatory in the near future.)

7.  Unlike the FDA, which issues the rules for drugs and vaccines and does not always follow its advisory committees' guidance, the CDC claims to allow its advisory committee to make the decisions about how vaccines should be used.  I could not recall a time that the CDC Director had tried to overrule its advisory committee.  Helen Branswell of Stat says it happened only once before, in 2003 over the smallpox vaccine.  But on 9/24/21 CDC Director Walensky overruled the advisory committee to broaden the recommendation for a third dose to practically all Americans aged 18 and over. 

The 2003 decision to vaccinate Americans for smallpox, which had been wiped out in 1977, was totally political, designed to scare Americans into going to war against Iraq, where no smallpox was ever found. The civilian vaccination program soon died, after only 40,000 Americans were injected, due to myocarditis, heart attacks, heart failure and deaths. This is an earlier example of how political programs are hidden under the guise of healthcare.

How will CDC be able to hide behind ACIP's skirts, claiming that ACIP makes the vaccine decisions, when this time ACIP didn't?  As an example, this MMWR report shows that the Recommendations normally come directly from the ACIP, not from the CDC or its Director.

8.  The Biden administration eventually got what it said it wanted, but at the cost of revealing it didn't give a damn about the Science.  Both the FDA and CDC leadership were forced to publicly ignore the evidence as well as their own advisers.

9.  A usual suspect was trotted out to applaud the tyrants:

"American Medical Association President Gerald E. Harmon, M.D., applauded Walensky's leadership and said that his organization believes the recommendation "is a critical step to preserve our nation’s health care capacity and prevent illness among those who have continued to put their own health and safety at risk to care for patients."'

As I noted a few days ago, Harmon, a 2-bit family practitioner from South Carolina, rode to fame and fortune as a flight surgeon by exposing and punishing anthrax vaccine refusers with an iron hand, eventually making Major General. This is a 'leader' who knows on which side his bread is buttered.

10.  Lots of boosters are coming, since the US Government and other governments have already purchased them.  New vaccines are a super conduit for graft and corruption.They are sold for several times more than what they cost to make; the profits are incalculable; and so there is an awful lot of money available to pay for "lobbying," i.e., lobbing cash at politicians.

11.  I like Stat's headline for this story:  Biden’s chaotic messaging on Covid-19 boosters is pitting the White House against the government’s scientific advisers. The WaPo's headline isn't bad:  Changes in booster shot guidance leads to confusion, chaos for doctors and the vaccinated.

12.  However, the bottom line is that virtually any adult could already go to a drug store and get a booster.  "Pharmacies, where over 70 percent of vaccine doses are being given, won’t require additional documentation."


Anonymous said...

I love these big picture summaries of what is going on! Thank you!

Anonymous said...

Good News?
Reven Holdings Announces Successful Completion of the First Part of RPI015 Clinical Trial Evaluating Its Lead Anti-sepsis Drug Candidate RJX in Hospitalized High-risk COVID-19 Patients.

12 hospitalized adult patients with symptomatic high-risk COVID-19 pneumonia and abnormally elevated inflammation markers in the blood were treated with daily intravenous infusions of RJX in combination with standard of care. Nine (9) of the 12 patients, including 3 patients with hypoxemic respiratory failure, showed rapid clinical recovery with normalization of the blood oxygen levels and abnormally elevated inflammation markers. They were discharged from hospital between 3-14 days (median = 5 days). All patients tolerated their RJX infusions without any side effects.

Anonymous said...

Had we done with polio what we're doing now with Covid -- IPV (non-sterilizing) use only with virus circulating in the United States -- it is very likely the virus would have mutated, escaped the vaccine and killed millions in America. Every single so-called expert knows damn well why we didn't do that with polio and how dangerous it is to attempt it. Indeed where polio still circulates but money is scarce they use OPV only (which is sterilizing) and accept the risk of the rare but possible active case it can cause for this exact reason.

Again: This is not a "new idea"; it was in fact the only rational path of action and known decades ago, forming the very basis of our polio vaccination strategy. This combination strategy was necessary for polio but not for measles, for example, as the measles vaccine is sterilizing.


Anonymous said...

Can you imagine if we had a Govt, that really cared about it's people, 'IVERMECTIN'?
Time to hold people accountable -- personally.?

Hospital administrators, doctors, politicians, Fauci, both past and present Directors of the CDC, the FDA, school administrators, college provosts, CEOs who have been jab-happying their employees and every single screaming Karen on social media.

Anonymous said...

Just an FYI, the FDA Fact Sheet was Revised on 09/22/2021, looks like similar INFO is still in their?

Meryl Nass, M.D. said...

I think the fact sheet was revised to account for the FDA decision on the Pfizer applicaiton that same day.