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FDA Is Reportedly Preparing a Black Box Warning for COVID-19 Vaccines

The reported label change remains under internal review with key details on scope and timing unresolved.

In May, the FDA said it was requiring safety warnings in the prescribing information for the Covid-19 vaccines from Pfizer and Moderna.
President Donald Trump delivers remarks during the Congressional Ball at the White House on Thursday.
One study estimated that in their first year of use, Covid-19 vaccinations averted almost 20 million deaths around the world.
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Overview

  • CNN, as relayed by Reuters, reports the FDA intends to add its most serious safety warning to COVID-19 shots.
  • The proposal is being led by Dr. Vinay Prasad, the agency’s chief medical and scientific officer and head of CBER, according to the report.
  • The plan is not final, and it is unclear whether any warning would apply to mRNA vaccines only or to all products and age groups, with unveiling expected by year-end.
  • HHS said on Dec. 9 that the FDA is investigating deaths potentially related to COVID-19 vaccines across multiple age groups as part of a safety review.
  • Pfizer, Moderna, Novavax and HHS did not immediately respond to Reuters’ requests for comment.