The FDA has called for Pfizer and Moderna to update the safety information on their mRNA COVID-19 vaccines to include warnings on the incidence of myocarditis and pericarditis, according to two letters shared on the agency’s website.
Dated April 17, the letters appeared on the FDA website May 21, hours before a scheduled Senate Homeland Security and Governmental Affairs Committee hearing investigating whether health officials “downplayed and hid” adverse outcomes related to COVID-19 vaccines, according to a May 21 CBS News report.
The nearly identical letters instruct the drug manufacturers to replace current warning language with the following:
“Based on analyses of commercial health insurance claims data from inpatient and outpatient settings, the estimated incidence of myocarditis and/or pericarditis during the period 1 through 7 days following administration of the 2023-2024 Formula of mRNA COVID-19 vaccines in individuals 6 months through 64 years of age was approximately 8 cases per million doses. The highest estimated incidence was in males 16 through 25 years of age (approximately 38 cases per million doses).”
The warning labels are also required to include information on the cardiovascular outcomes of patients diagnosed with mRNA COVID-19 vaccine-associated myocarditis based on a study published Sept. 6, 2024, in eClinicalMedicine. Two corrections to the study, which study authors classified as “typographical errors,” were published May 21.
Pfizer and Moderna had 30 days from the date of the letters to respond to the FDA with proposed changes or a rebuttal statement.
Becker’s has reached out to Pfizer and Moderna and will update this article if more information becomes available.
