For years, it’s been common practice at the FDA to routinely approve upgraded versions of existing vaccines with an oversight process best described as rubber stamping.
But the days of the FDA quietly approving vaccines may be over – bright news for activists from the Medical Freedom Movement.
Earlier this week, Dr. Vinay Prasad, the man who replaced Peter Marks, the FDA’s controversial vaccine official, boldly overruled FDA regulators who had recommended all three COVID vaccines for all age groups, including healthy children.
While the approval process for vaccines gives regulatory bodies the opportunity to scrutinize products before they hit the market, in reality, this hardly ever happened. Today, however, FDA leadership is empowered to scrutinize vaccines to insure their safety.
More importantly, the current FDA is challenging the past orthodoxy of a “one-size-fits-all” approach. In its place: the empirical “gold standard” scientific analysis that HHS Secretary Robert F. Kennedy Jr. had been promising.
Dr. Prasad, the new head of the FDA’s Center for Biologics Evaluation and Research (CBER) – which regulates vaccines, blood products and more – explained this new approach both online and in a detailed memorandum.
In his memo, Dr. Prasad writes that in considering the approval of Moderna’s updated mRNA COVID vaccine (“SPIKEVAX”), the FDA must weigh the benefits of the product against its risks. Only then can a specific approval process result in a scientifically sound recommendation. “FDA has a statutory mandate to only approve products when we have substantial certainty that benefits outweigh harms,” Prasad writes in his memo. Referring to Moderna’s submission, he adds, “We do not have substantial certainty [that] benefits outweigh risks of healthy children.”
Dr. Prasad elaborates: “First, consider that COVID-19 severe disease, hospitalization, and death are extremely low at pediatric ages and have fallen, according to US CDC data from 2021-22 to the present.”
Dr. Prasad continues, “These rates are lower in healthy children than in children with risk factors. Notably, the applicant has agreed to a revised submission that focuses on children with risk factors, and FDA CBER has granted this approval.”
Hellbound and Down 