The FDA had given Pfizer and Moderna until May 17 to propose changes to the labels of their COVID-19 vaccines or challenge the agency’s directive. The products’ labels already include myocarditis warnings, albeit for different age groups.
The FDA has requested that Pfizer and BioNTech and Moderna update the labels of their COVID-19 vaccines to reflect their associated risks of cardiovascular complications.
In separate letters to Pfizer/BioNTech and Moderna, which were sent on April 17 but posted online on Wednesday, the regulator flagged the “persistence of abnormal cardiac magnetic resonance imaging findings that are a marker for myocardial injury” in patients who had been given the companies’ respective COVID-19 vaccines.
These cases, alongside documented cases of myocarditis and/or pericarditis, constitute what the FDA called “new safety information” that “should be included in the labelling for mRNA COVID-19 vaccines,” as per the letters.
The FDA gave Pfizer/BioNTech and Moderna 30 calendar days from the date of the letter—or until May 17—to submit proposed labelling changes or contest the agency’s requirement for the safety update.
Both vaccines already have warnings reflecting this risk, however. The label for Pfizer/BioNTech’s Comirnaty notes that the risk of myocarditis and pericarditis is “highest in males 12 through 17 years of age,” while the label for Moderna’s Spikevax cautions that the risk of these complications is “highest in males 18 through 24 years of age.”
The FDA in its letters seeks to refine this age range for both vaccines, asking the companies to adjust their labelling to say “the highest estimated incidence of myocarditis and/or pericarditis was in males 16 through 25 years of age.”
Myocarditis and pericarditis—the inflammation of the heart muscle and heart lining, respectively—have long been known to be a side effect of mRNA COVID-19 vaccines.
This FDA’s request comes amid much disturbance in the COVID-19 space, triggered largely by policy changes by the new Trump administration. On Tuesday, the FDA unveiled a new risk-based framework for approving new COVID-19 vaccines, putting a particular focus on seniors over 65 years and high-risk individuals six months through 64 years of age. These populations, according to the CDC, are more at risk for obesity, mental conditions like depression and cardiovascular health risks that put them at higher risk of COVID-19 infections.
In a town hall meeting to discuss these changes, newly appointed Center for Biologics Evaluation and Research director Vinay Prasad focused on the alleged public distrust sown by the current guidelines. “We have launched down this multi-year campaign of booster after booster after booster and distrust of the American public, and we do not have gold standard science to support this for average-risk, low-risk Americans,” he said.
Last week, the FDA finally approved Novavax’s COVID-19 shot after a six-week delay, but—seemingly in keeping with these new guidelines—with notable restrictions. Novavax’s Nuvaxovid is only indicated for older adults 65-plus, and individuals aged 12 through 64 with “at least one underlying condition that puts them at high risk for severe outcomes from COVID-19.”
