Biologics

Expand mRNA Covid Vaccine Warnings: FDA

FDA is telling Pfizer and Moderna to expand the label Warnings for their mRNA Covid-19 vaccines (Pfizer’s Comirnaty and Moderna’s Spikevax) to describe the risk of a possible heart injury side effect, primarily in teen boys and young men. CBS News reports that the expanded Warning reflects findings from a study published in 2024 and new agency data.

The report says both vaccines previously had Warnings about how the risk of myocarditis and pericarditis looked to be higher in young men, generally within the first week after vaccination. The expanded Warnings will apply to males aged 16 to 25 for both vaccines, CBS says. The Warning estimates a case rate of 38 cases per million.

The report says it is unclear whether either company disputed the order. Spokespersons for the two companies did not respond to a CBS request for comment.

In an emailed statement to CBS, HHS spokesperson Andrew Nixon said, “Americans deserve radical transparency around the safety and efficacy of Covid vaccines and FDA is delivering on their promise to do just that. Spikevax and Comirnaty should take steps to ensure that individuals are aware of Covid vaccine-related adverse events resulting in myocarditis and pericarditis.”

As study results indicated, the new Warning says the heart issues improved over time in most people.

“It is not known if these heart MRI findings might predict long-term heart effects of myocarditis,” FDA says. “Studies are underway to find out if there are long-term heart effects in people who have had myocarditis after receiving an mRNA Covid-19 vaccine.”

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome