FDA Seeking Expanded Warning Labels for COVID-19 Vaccines
WASHINGTON — The Food and Drug Administration has directed Pfizer and Moderna to expand warning labels on their COVID-19 vaccines to include risks of a heart injury side effect associated with the mRNA shots.
According to letters to Pfizer (and its vaccine partner BioNTech) and Moderna dated April 17 and posted on the agency’s website Wednesday, the risk of the side effect is primarily run by teenage boys and young men.
The request is based on findings from a study published last year and new data gathered by the industry.
The existence of the letters was first reported by The Washington Post.
They apply to Pfizer and BioNTech’s Comirnaty vaccine and Moderna’s Spikevax vaccine.
Both vaccines previously carried warnings about the risk of potential heart-related side effects, including myocarditis (an inflammation of the heart muscle) and pericarditis (inflammation of the membrane surrounding the heart).
The requested change in the labels for both vaccines will now say the warning applies to males ages 16-25.
The rate of myocarditis and pericarditis was around eight cases per million doses for children and adults under 65 years old after use of that season’s vaccines, the FDA said.
The publication of the letters on the FDA’s website is just the latest action it has taken regarding the COVID-19 vaccine in the past two weeks.
On Friday the agency announced it would limit access to COVID-19 vaccines going forward to people 65 and older and people with at least one health condition who are at high risk of becoming seriously ill if they are infected.
It also directed that the manufacturers conduct clinical trials to show whether the vaccines benefit healthy younger adults and children.
The new iterations of the COVID-19 vaccines are expected to be available in the fall. It is estimated that more than 100 million Americans will still be eligible for the shots under the new framework.
Dan can be reached at [email protected] and @DanMcCue
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