Looks Like a “Black Box” Warning Will Be Put on Covid-19 Vaccines

The US Food and Drug Administration (FDA) plans to add a black box warning on COVID-19 vaccines by the end of the year. The FDA is within the Department of Health and Human Services (HHS), run by Secretary Robert F Kennedy. The FDA commissioner reports to the HHS Secretary.

A black box warning would highlight risks, such as serious possible side effects that would include myocarditis or sudden unexpected deaths, to be weighed against benefits. The plan has not been finalized, and the FDA has not officially announced the change.

An FDA memo from late November this year stated that after an analysis of 96 VAERS-reported pediatric deaths (2021–2024), at least 10 children died due to the mRNA COVID-19 vaccines, primarily via myocarditis. The memo, by Dr. Vinay Prasad, the FDA’s chief medical officer, an internal review of those 96 reports concluded “no fewer than 10” were related to vaccination.

Nonetheless, many health experts have since argued that there is no basis for the warning.

Many medications have these warnings. Opioids do, vaccines like the smallpox vaccines do.

Critics say there is no reason for this extreme warning, the most serious warning the FDA issues for medications.

However, if there are ten dead children out of 96 because of the COVID-19 vaccine, there could be more.