FDA Rejects Moderna Jab for Healthy Children

By Adam Garrie, Louis Conte, and Staff of The MAHA Report

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.”

Dr. Prasad’s reasons for rejecting the Moderna vaccine include:

• Is there substantial certainty of a net clinical benefit to vaccinating healthy children with this mRNA vaccine? CBER OCDs answer is, at the present time, with best available information, no.

• Moderna has never shown a reduction in severe COVID-19, hospitalization, ICU stays or death in a randomized study in children.

• Moderna has not shown that COVID-19 vaccination reduces long covid or transmission in any setting at any age with high quality data. Neither has the applicant nor a third party shown fewer missed days of school with high quality data.

• Vaccinating these individuals (healthy kids with natural immunity) carries massive uncertainty as to whether benefits outweigh risks.

• Although COVID-19 vaccines have been given to billions of individuals and the harms have been studied in depth, no one knows if these products have harms that only materialize 10 or 20 years later, as such is a necessary limit of time. It is ignorant to claim that unknown long term risks are not possible.

• Antibodies are not gold standard science, and one cannot be certain of net clinical benefit merely because antibodies are increased. Vaccine doses can increase antibodies, but fail to further improve clinical outcomes.

• Randomized trials measuring clinical outcomes will be required to approve these products for healthy individuals.

• FDA is ultimately accountable to the American people, and Americans have overwhelmingly stated that they feel the evidence to vaccinate a healthy child with a COVID-19 mRNA product is not enough to compel them to act. CBER OCD, after careful examination of the scientific evidence, agrees with the vast majority of Americans.

Reflecting on Prasad’s bold move at the FDA, and Kennedy’s “wins” at HHS, MAHA PAC co-founder Tony Lyons said, “The bottom line is things are moving in the right direction. Secretary Kennedy has always said that we must return gold star science to HHS. When the data is out, he will move accordingly.”

Continued Lyons, “Kennedy is being true to his word. Do you think any previous FDA would have rejected the approval of any vaccines, let alone covid vaccines? We don’t think so! This is a massive step forward.”