At
Science-Based Medicine Dr. David Gorski wrote, " Specifically, through his useful idiots at the FDA, RFK Jr. is working to weaponize VAERS data to justify making vaccines harder to approve. In this case, the useful is an old “friend” of the blog,
Dr. Vinay Prasad, the medical oncologist turned COVID-19 contrarian turned antivax-adjacent who is
now in charge of the Center for Biologics Evaluation and Research (CBER), the center at the Food and Drug Administration responsible for approving and regulating vaccines and biologics..."
Dr. Gorski continued, "Does anyone remember Biden-era pandemic-era Dr. Prasad? One of his main complaints about The Powers That Be at FDA and CDC was a “lack of transparency” in how the CDC developed its recommendations and the FDA approved vaccines and evaluated adverse events due to vaccines. This story, more than anything else, shows that, under the guise of “greater transparency” what Dr. Prasad is doing is anything but transparency and basically boils down to, “Trust me, bro.” Indeed, one of the first things that struck me about these stories and about Dr. Prasad’s email, the full text of which is
now widely available, is the utter lack of transparency and the arrogance and dismissiveness of its author." Dr. Gorski quoted a portion of a story at WaPo:
Vinay Prasad, an FDA official whose approach to vaccine policy has been championed by Health Secretary Robert F. Kennedy Jr., told agency officials that the FDA will rethink its framework for annual flu shots, examine whether Americans should be receiving
multiple vaccines at the same time and require vaccine makers to show far more data to prove the safety and value of their products. For instance, Prasad said that pneumonia vaccine makers must demonstrate that their products reduce pneumonia, at least after they become available in the market, rather than just generate antibodies to fight infections.
Prasad also wrote that the new approach means the agency will have strict requirements for authorizing new vaccines for pregnant women. He concluded his lengthy email by maintaining that he was open-minded about next steps.
“I remain open to vigorous discussions and debate,” Prasad wrote to his team, adding that staff who did not agree with the core principles of his new approach should submit their resignations.
Now there’s the arrogant, dismissive Dr. Prasad we’ve all come to know and detest! Just listen to him! He proclaims himself to be open to “vigorous discussion and debate”; that is, unless you disagree with the core principles of his new approach, in which case you should resign. Indeed, this email is quite consistent with previous reports of the
vindictiveness and paranoia with which Dr. Prasad runs CBER, which have led to a hemorrhaging of career scientists.
To recap, yes,
myocarditis among young people was an adverse event noted in Israel and the US within a few months of the rollout of the mRNA-based COVID-19 vaccines. This discovery, according to Dr. Prasad in his email, was “missed” by the CDC and FDA (it wasn’t). Dr. Angela Rasmussen provides a nice
summary, describing a study in which Høeg and Prasad dumpster-dove into the VAERS database:
In reality, Høeg and colleagues estimated a rate of myocarditis in adolescent boys receiving the second dose of an mRNA vaccine to be
more than twice the rate (162/million vaccines) calculated by
an actually qualified team led by vaccine safety experts from CDC (71/million vaccines). Both studies used data from VAERS, although the CDC inclusion criteria were more stringent than Høeg’s, and thus more likely to exclude cases that were not relevant to assessing the risk of myocarditis from vaccination.
Prasad and Høeg also evidently ignored data showing that
vaccine-induced myocarditis rates have declined further in the years since Høeg’s initial study, as well as data showing that
the risk of myocarditis is much, much higher from COVID infection than vaccination.
I
also deconstructed the Høeg/Prasad study, characterizing it as
typical VAERS dumpster-diving, a continuation of a common antivax trope of
weaponizing VAERS to portray vaccines as dangerous. I also have to tip my hat to our own Dr. Jonathan Howard for steering me to this paper, which suggests that myocarditis after vaccination might actually be less common than thought..."