Food and Drug Administration (FDA) Commissioner Marty Makary on Monday denied recent reports suggesting plans for his agency to add a black box warning onto COVID-19 vaccines.
CNN reported last week that the FDA was considering adding a black box warning onto the COVID-19 vaccine, citing two sources familiar with agency plans. A black box warning is the highest safety-related warning that the FDA can assign to a product.
Makary on Monday dismissed these reports.
“When it comes to the black box warning, we have no plans to put that on the COVID vaccine,” said Makary.
“The safety and epidemiology center within the FDA did recommend that,” he added. “It was a recommendation formally put out. But some of our scientists and leadership, like Dr. Vinay Prasad have said it may be different today than it was in the first year of COVID when the shot came out. Because when you have those two doses three months apart, that’s when you see the side effects go way up like myocarditis in young people.”
Myocarditis, inflammation of a heart muscle, is a rare but serious side effect of COVID-19 vaccinations. It occurs more frequently among young men. The potential side effect has caused alarm among vaccine skeptics. Infectious disease experts have argued that COVID-19 infections have a significantly higher risk of causing myocarditis than the vaccines.
According to a meta-analysis put out this year by Pfizer, maker of the COVID-19 vaccine Comirnaty, the risk of myocarditis due to COVID-19 infection is about 42 times higher than myocarditis due to vaccination.
“Now that it’s annual, you may not see that same prevalence. So, we don’t want to extrapolate findings to today if it’s not transferable,” Makary noted.
The FDA last week launched an investigation into a possible link between COVID-19 immunizations and deaths. Makary on Monday said the investigation is looking into whether information on these deaths should be public.
“We believe they should, but we wanted to make sure that, in fact, there was truly a link between the COVID shot and the death before we make it public,” he said.