The US Food and Drug Administration will need the Pfizer/Biontech and Moderna Covid-19 vaccines to use extended warning labels with more information about the risk of rare heart disease after vaccination.
Previous labels of the vaccine warned of the risk of heart disease called myocarditis, myocardial inflammation, pericarditis, and inflammation of the outer lining of the heart. The new label extends that warning to a specific age group.
Research consistently shows that mRNA covid-19 vaccines are safe and effective, and that millions of people are getting them without serious incidents. Some studies have found that Covid-19 infection itself is at a higher risk of myocarditis or pericarditis than vaccines.
The CDC told an independent vaccine advisor last month that the study showed that COVID-19 vaccinations from 2020 to 2022 showed a statistically significant increased risk of myocarditis. However, the incident is rare and “there is no increase in risk observed at doses administered in the following years,” the agency said.
In rare cases, in cases where someone has had heart inflammation after vaccination, the CDC told the advisor that acute myocarditis usually resolves quickly.
The vaccine already carries a warning that the highest risk of these heart problems was observed in men between the ages of 18 and 24, in Pfizer’s case, in 12-17 people. New warnings for both vaccines are for men ages 16 to 25.
In a letter to Pfizer and Modanya currently posted online on April 17, the agency said analytical data on commercial health claims indicates that there are eight cases of myocarditis and/or pericitritis per million doses given to people between the ages of six months and 64.
Cases were more common among men ages 16 to 25 within 7 days of vaccination, but still rare, with around 38 cases of myocarditis and/or pericititis per 100 doses among this group.
A spokesman for the U.S. Department of Health and Human Services said Wednesday that the move aims to increase “radical transparency.” Neither Pfizer nor Moderna responded to requests For comments.
The vaccine was developed during the first Trump administration, experiencing what the CDC says is “the most intensive safety analysis in US history,” and agencies continue to monitor vaccine management data for efficacy and potential issues.
Longtime anti-vaccine activist, US health and welfare secretary Robert F. Kennedy Jr., falsely claims the Covid-19 vaccine is “the deadliest vaccine ever made.”
During a hearing of the U.S. Senate Homeland Security and Government Subcommittee, Sen. R-Wisconsin, Sen. R-Wisconsin, claimed that the Biden administration underestimated vaccine risks and delayed the acquisition of information on those risks.
One witness, Hawaii Gov. Josh Green, in his testimony, said the US vaccine safety surveillance system worked “accurately” by detecting rare cases of myocarditis.
“The data was published, the warnings were updated and clinical guidance was revised accordingly,” Green said. “Nevertheless, some continue to promote misleading interpretations, unverified claims, or anecdotes, suggesting that vaccines are broadly unsafe.”
The FDA has taken recent steps to limit Covid-19 vaccines in certain groups.
On Tuesday, the FDA said it would change the type of evidence it accepts from vaccine manufacturers to approve updated Covid shots that could be restricted to those qualifying for the latest shot. The vaccine is expected to be available in the fall, but only for adults over the age of 65 and those with underlying conditions at high risk for severe Covid-19 infection.
In an editorial published in the New England Journal of Medicine, FDA Commissioners Dr. Marty McCurry and Dr. Vinai Prasad, the new directors of the FDA’s Center for Biology Assessment and Research, state that there is no sufficient evidence that healthy children and adults are gaining clinically meaningful benefits from regular Covid-19 shots, and civil servants want to see more Playvo Control Trials.
On Thursday, the FDA’s vaccine advisors (the Vaccine and Related Biological Products Advisory Committee) will meet to discuss the selection of coronavirus strains for the Covid-19 vaccine this fall.
CNN’s Brenda Goodman contributed to this report.