The Novafix

On Tuesday, June 7, the Vaccines and Related Biological Products Advisory Committee (VRBPAC) will consider evidence supporting emergency use of Novavax COVID-19 Vaccine.  The outcome of these proceedings is nearly certain.  The committee’s endorsement will be followed by a swift EUA letter from the FDA and recommendation by the CDC.  The only uncertainty is how many times committee members will contradict previous statements in their sycophantic rush to fawn over this new all-protein vaccine.

FDA webmasters have already been hard at work, excavating a location for the new vaccine’s authorization documents.  Click here today and you will see the placeholder for the Novavax Recipient-Caregiver Fact Sheet.  Next week, the same link will bring up the actual documents.

Wall Street is also lining up behind the new vaccine.  According to a recent article published on Nasdaq.com, “So far, in all previous global regulatory approvals in other regions, there has been ‘minimal to no debate’ on the highly effective and safe credentials of the vaccine as shown in the 3 large-scale Phase 3 studies. And going by previous examples of such EUA FDA panels, following a positive vote by VRBPAC panelists, Mamtani [an analyst working for B. Riley Financial] expects a ‘prompt FDA approval.’”

The article continues, “Accordingly, Mamtani reiterated a Buy rating on NVAX shares, backed by a $181 price target. Investors stand to take home about 227% gain, should the target be met over the next 12 months.”  This is Mr. Mamtani’s recommendation, not mine.  I am a practicing pathologist and do not give financial advice.  I only reference this article to restate a previous point—this is about the money.

The fix is in.  As Wall Street proclaims this new vaccine “highly effective and safe,” expect committee members to opine at length that the new vaccine is new technology.  Since it does not use mRNA, it should be readily accepted by the unvaccinated holdouts by removing their objection to gene therapy.  Obsequious committee members will heap praise on the company for producing this missing piece to the pandemic puzzle.

Their praise will create a contradiction that undermines the committee’s credibility.  If the war on pandemic requires another vaccine, then the vaccines currently available must not be the panacea we were told previously.  To believe what the committee will say this week, we must stop believing that what the committee said previously about mRNA vaccines being “safe and effective.”  Maybe they are not safe enough or not effective enough.  Otherwise, why would a new vaccine meet requirements for emergency use authorization?  And if we must stop believing something they have said before, why should we believe them now?  This is not science.  This is politics.

Tuesday’s committee discussion will not recognize any of the problems with the Phase 3 trial published in the New England Journal of Medicine earlier this year.  They will not consider the failure of vaccine to reduce all-cause mortality, the high number of short-term adverse effects, or the elimination of the control group after two months.  They will simply parrot the study’s conclusion of “safe and effective” without critical examination of the study’s flaws, and without mentioning that the study that was funded by the vaccine maker.

By the end of the week, a new vaccine will be available to Americans.  The new vaccine will not met rigorous approval standards, but it will have the same manufacturer liability exemptions as the other EUA vaccines.  Novavax stands to make a lot of money with minimal risk.  However, there is little evidence that this new vaccine will create a health benefit for Americans.