Image 01 Image 03

FDA Expands Probe Into COVID Vaccine Linked Deaths to Cover Adults

FDA Expands Probe Into COVID Vaccine Linked Deaths to Cover Adults

In related news, FDA Commissioner Marty Makary claims Biden administration withheld data on heart risk from Covid vaccines.

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.

DONATE

Donations tax deductible
to the full extent allowed by law.

Comments


 
 0 
 
 1
Peter Moss | December 11, 2025 at 2:40 pm

I know it’s purely anecdotal but I’ve never felt the same since I did two rounds of the Moderna vaccine.

I caught COVID in New Orleans just before Mardi Gras and thought I was going to die. I got the shot and I was *certain* I was going to die. Fortunately for me, I didn’t.

I said to anyone who’d listen back in 2020 that the consequences of our government’s actions to the pandemic would be worse than the pandemic itself.

I think my prediction has held up.


 
 0 
 
 0
Joe-dallas | December 11, 2025 at 2:49 pm

I never got the covid vax primarily due to my personal health / fitness level.

I never perceived that covid would be a risk to me greater than a mild flu (which turned out to be correct) .

Covid was a risk to the elderly and as such, taking the vax was reasonable for that sub group of the population. For most everyone else, taking the covid vax was providing very limited protection likely impaired a more robust long term immunity from natural infection.

The risk of heart issues from catching covid vs from the vax is definitely happening, though based on the research that I have seen, there is slightly higher risk of heart issues from natural infection than from the vax, though the increase in risk is not statistically significant. Further, the risk either way is extremely low. As such, the hype on this issue is overblown.


 
 0 
 
 0
rhhardin | December 11, 2025 at 3:03 pm

The vax was effective for the variant it was designed for. It was to reduce the average number of cases a given case infects to less that one point zero. Then the epidemic dies out, mathematical fact. They immunized the population starting in December 2020 and by May 2021 the original variant was essentially gone, without most of the population having been infected. Delta was starting up but not widespread yet.

The vax had no benefit for other variants and that was idiotic to push.


 
 0 
 
 0
Ironclaw | December 11, 2025 at 3:13 pm

Long overdue, in fact they should have looked at this sort of thing before giving authorization.

Leave a Comment

Leave a Reply

You must be logged in to post a comment.

This site uses Akismet to reduce spam. Learn how your comment data is processed.