A few days ago, I reported that Dr Vinay Prasad, as the Director of the FDA’s Center for Biologics Evaluation and Research (CBER), issued a memo asserting that an internal review conducted by FDA staff members concluded that at least 10 children died “after and because of receiving” a Covid‑19 vaccine.
In a nutshell, Prasad argues that existing data on COVID-19 vaccination in children are too limited and methodologically biased (especially observational studies and myocarditis analyses) to reliably quantify benefits, compare risks with infection, or determine whether the vaccination program saved more children than it harmed. He also contends that VAERS underreporting, subjective causality judgments, and poor enforcement of post‑marketing studies mean current official conclusions understate vaccine‑related harms and overstate certainty about safety.
The memo was not the ranting of an “anti-vaxxer”, but a sound review by someone well credentialed to make a judgment on the information available.
Now the Food and Drug Administration (FDA) has announced an expansion of its probe that will cover multiple groups.
The Food and Drug Administration has expanded its investigation of deaths possibly linked to the Covid vaccine to include adults as well as children, according to a Trump administration official….“F.D.A. is doing a thorough investigation, across multiple age groups, of deaths potentially related to Covid vaccines,” Andrew Nixon, a spokesman for the Department of Health and Human Services, said on Tuesday.The broader review follows a memo in late November by Dr. Vinay Prasad, the F.D.A.’s top vaccine regulator, who informed staff members that the agency had linked about 10 children’s deaths to the Covid shots. He highlighted the dangers of myocarditis, or inflammation of the heart muscle, which the agency has for years cautioned is a rare but worrying side effect, especially among teenage boys and young men.
The mainstream media continues to insist the vaccine, which certainly hasn’t been “effective”, is safe nonetheless. This bit comes from CNN’s report on the announcement:
More than 700 million doses of Covid-19 vaccines have been administered in the US since they became available in late 2020, according to the World Health Organization. The shots have been extensively tested and continually monitored for safety, and serious side effects such as anaphylaxis or myocarditis have been generally rare.FDA regulations require health care providers to report deaths after vaccination to the Vaccine Adverse Event Reporting System (VAERS), even if it’s not clear that vaccination was the cause of death. Members of the general public can also submit events to the database, which federal agencies use to generate further study on vaccine safety.
In related news, FDA Commissioner Marty Makary says the Biden administration withheld data from the public on the risks of myocarditis from COVID-19 vaccines.
“We have done more to study myocarditis and to go back and look at deaths of people, of children from the Covid vaccine,” Makary told NBC News in an interview. “Internal data submitted on myocarditis, we found that the Biden administration was sitting on data on myocarditis in young people, and it was not made public.”…Myocarditis, an inflammation of the heart muscle, is a known — but small — risk of the mRNA Covid vaccines from Pfizer and Moderna, information that federal agencies have discussed openly since 2021.The FDA has not released its new findings publicly, nor has the agency published them in a peer-reviewed journal. On Wednesday, a dozen former FDA leaders issued a scathing denunciation of the new assertions.
It will be interesting to see what conclusion the new FDA team comes to after completing this probe. Stay tuned, as I sense 2026 will be an illuminating year.
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