FDA official says coronary heart issues which may be related to gunshots are uncommon

A health care worker administers a dose of Pfizer-BioNTech Covid-19 vaccine to a child at a pediatrician in Bingham Farms, Michigan, USA on Wednesday, May 19, 2021.

Emily Elconin | Bloomberg | Getty Images

Inflammation of the heart in adolescents and young adults who have received Covid-19 vaccines appears to be very rare, and it remains unclear whether the problem is actually related to the shots, said Food and Drug Administration’s top vaccine regulator Dr. Peter Marks, on Thursday.

The Centers for Disease Control and Prevention’s vaccine safety group announced last week it was looking at a condition called myocarditis, which is inflammation of the heart muscle in “relatively few” people who have received Covid vaccinations.

Myocarditis can affect the heart muscle and electrical system, “reducing the ability to pump and causing fast or abnormal heart rhythms,” according to the Mayo Clinic.

The cases predominantly occurred in adolescents and young adults and usually occurred within four days of the shot, according to the CDC. The condition has been seen more frequently in men and most cases appear to be mild, the agency said, although officials are following up on patients.

“We still don’t know if this is really vaccine-related,” said Marks, director of the FDA’s Center for Biologics Evaluation and Research, during a virtual Q&A event with the COVID-19 Awareness and Justice Project of vaccines.

The CDC is coordinating its investigation with the FDA, which recently approved the Pfizer BioNTech vaccine for adolescents ages 12-15. The vaccine has been available to Americans 16 and over since December. Moderna and Johnson & Johnson vaccines are available for ages 18 and over.

Health experts say it is common to find rare side effects when a vaccine or drug is administered to the general population. If myocarditis is found to be related to the Covid vaccine, the risk is negligible compared to the risks of infection with Covid-19.

Marks, who has been with the FDA for nearly a decade, added Thursday that the “handful” of reported cases were “very mild, lasted a day or two,” and usually occurred after a second dose.

“My kids are a little older, but I wouldn’t hesitate to vaccinate my kids just because it’s a pretty rare finding and we don’t really know yet if it’s really related to the vaccines,” he said.