The Food and Drug Administration (FDA) has directed BioNTech and Moderna to expand the warning labels on the COVID-19 vaccine to include warnings for heart inflammation.
The letters, made public on May 21, were dated April 17 and urge the vaccine developers to add, “Following administration of the 2023-2024 Formula of mRNA COVID-19 vaccines, the highest estimated incidence of myocarditis and/or pericarditis was in males 16 through 25 years of age” to the label.
“In accordance with section 505(o)(4) of the FDCA, we are notifying you that based on the new safety information … we believe that the new safety information should be included in the labeling for mRNA COVID-19 vaccines,” the letters state.
“Americans deserve radical transparency around the safety and efficacy of COVID vaccines and the FDA is delivering on their promise to do just that. Moderna and Pfizer should take steps to ensure that individuals are aware of COVID vaccine-related adverse events resulting in myocarditis and pericarditis,” Health and Human Services spokesperson Andrew Nixon told CBS News in an emailed statement.
The public release of the letters comes as a report released by Senator Ron Johnson (R-WI) reveals that Biden administration officials “withheld crucial health information” from the Senate Permanent Subcommittee on Investigations. The report “highlights records the Subcommittee has reviewed regarding HHS’s awareness of and response to cases of myocarditis—a type of heart inflammation—following COVID-19 vaccination,” it says.
Documents obtained by the committee “contain evidence of the Biden administration’s efforts to downplay and delay warning the public about the risks of myocarditis associated with the mRNA COVID-19 vaccines.”
