FDA Updates Warnings on COVID-19 Vaccines
WASHINGTON (AP) — On Wednesday, the Food and Drug Administration (FDA) announced it has broadened warnings regarding the two primary COVID-19 vaccines, focusing on a rare heart-related side effect primarily observed in young men.
This side effect, called myocarditis—a kind of heart inflammation that is usually mild—rose as a concern after the vaccines became widely available in 2021. Both Pfizer and Moderna had already informed doctors about this issue in their prescribing information.
Back in April, the FDA reached out to both companies, asking them to enhance the warnings with more specific details and to include a wider group of patients. While the FDA has the authority to mandate label changes, the process tends to be more of a negotiation with the manufacturers.
The updated warning indicates a risk of myocarditis at about 8 cases per million people vaccinated with the 2023-2024 COVID shots, particularly for those aged between 6 months and 64 years. The label specifies that incidents have been most notably reported in males between 12 and 24, expanding from the previous indication that focused mainly on 12- to 17-year-olds.
This FDA update seems to clash with previous conclusions made by scientists from elsewhere in the U.S. government.
The Centers for Disease Control and Prevention (CDC) previously found no increased risk of myocarditis in their vaccine injury monitoring databases for COVID-19 shots dating back to 2022. They emphasized that cases generally resolve quickly and are usually less severe than those linked to COVID-19 itself, which can also result in myocarditis.
The FDA’s announcement coincided with a meeting of new vaccine advisers appointed by Health Secretary Robert F. Kennedy Jr., who discussed the ongoing use of COVID-19 vaccines for various groups, including pregnant women. This meeting marked the first gathering of the CDC advisory panel since Kennedy dismissed all 17 previous members and formed a new group that includes several individuals known for anti-vaccine viewpoints.
The label change is part of a broader trend under Kennedy’s administration to limit or undermine vaccine usage. FDA Commissioner Marty Makary and a senior colleague recently narrowed the scope of annual COVID-19 shots, limiting them to seniors and higher-risk individuals. They’ve also hinted that seasonal adjustments to the vaccines may warrant additional testing.
Some experts believe the new warning is misguided.
“It’s valid to discuss the myocarditis risks from the vaccine, but what they’re recommending is not the right course of action,” commented Dr. Robert Morris, a public health expert at the University of Washington. “We really ought to be studying which individuals are more susceptible to myocarditis to find ways to predict and lessen that risk.”
Makary and others at the FDA gained visibility during the pandemic for claiming that the federal government overstated the advantages of COVID-19 boosters while downplaying significant side effects, including myocarditis.
Prior to joining the government, Makary, along with two of his current FDA colleagues, authored a 2022 paper arguing that mandating booster shots for younger people would lead to more vaccine-related injuries than it would prevent hospitalizations from COVID-19. This assertion went against the consensus of many prominent vaccine and public health professionals, including those at the CDC.
