Particle.news
Download on the App Store
12 ARTICLES
·
last wk.

FDA Expands COVID Vaccine Warning Labels Following Senate Report on Delayed Risk Disclosures

A Senate investigation alleges federal health agencies withheld myocarditis risk information for months in 2021, prompting new FDA actions to address transparency concerns.

The FDA is telling Pfizer and Moderna to expand warning labels about the risk of a rare heart condition after Covid-19 vaccination.
Image
Image

Overview

  • The FDA has mandated expanded warning labels for Pfizer and Moderna COVID-19 vaccines, specifying myocarditis and pericarditis risks for males aged 16 to 25.
  • A Senate report released on May 21, 2025, claims U.S. health agencies delayed informing the public about myocarditis risks despite early warnings from Israel in February 2021.
  • Internal deliberations in May 2021 led to the CDC posting limited clinical guidance online rather than issuing a formal Health Alert Network warning about the risks.
  • The report alleges that White House officials distributed talking points to downplay myocarditis risks and avoid alarming the public, prioritizing vaccine uptake over transparency.
  • While studies confirm the vaccines’ benefits outweigh risks, the report has reignited debates over regulatory accountability and public trust in health agencies.