Question

The FDA intentionally did not disclose certain risks related to the COVID vaccine and people have died because of it

Answer 1

The assertion that the FDA intentionally withheld known COVID‑19 vaccine risks is contradicted by a clear record of timely, publicly accessible warnings (including EUA fact‑sheet updates in June 2021 and expanded label requirements in 2025). FDA’s Emergency Use Authorizations (EUAs) for both the Pfizer–BioNTech and Moderna mRNA vaccines include explicit “Warnings and Precautions” sections describing myocarditis and pericarditis risks.

Though there is some risk of post-vaccine myocarditis (roughly 25-300 cases per million, depending on risk group), though it should be noted that this rate is far lower than the risk of getting myocarditis through the SARS-CoV-2 virus itself (roughly 1,500 cases per million), according to research published by the NIH. Causal attribution requires case‑level investigations (e.g., autopsy reports, medical examiner findings) showing that a failure to disclose a risk led directly to a death. With a lack of those to go off of, the second part of this claim is unverifiable.

Comments

It should also be pointed out that the original article implies that warning labels on the vaccines did not "disclose the very real risks of heart damage that [the vaccines] cause, particularly among adolescent boys and young men."
However, the warning label for Pfizer's vaccine (Comirnaty) specifies that the risk of myocarditis and pericarditis is highest in males 12 through 17 years of age, while the label on Moderna's vaccine (Spikevax) states that males between the ages of 18 and 24 face the highest risk.
The new FDA instructions require warnings on both vaccines to state that the risk is highest for males aged 16 to 25. Therefore, the risk to adolescent males was already stated on the warning labels, with the "expanded" warnings partly serving to bring uniformity in the age range based on recent studies.
https://www.cbsnews.com/news/fda-covid-vaccine-mrna-heart-side-effects-warning-label/
https://www.cnn.com/2025/05/21/health/fda-covid-vaccine-warning-heart-inflammation