WASHINGTON (dpa-AFX) - The U.S. Food and Drug Administration (FDA) is considering adding a 'black box' warning, its strongest type of safety alert, to COVID-19 vaccines, according to a CNN report.
It further noted that the idea is being pushed by Vinay Prasad, the FDA's top vaccine official. Notably, a black box warning appears at the top of a drug's safety label and is used only for the most serious risks, such as life-threatening side effects.
This discussion comes after the FDA recently updated warning labels on mRNA COVID-19 vaccines to note a rare risk of myocarditis and pericarditis, which cause inflammation and damage to the heart. While the current labels mention this risk, especially for males aged 12 to 24, a black box warning would raise it to the highest alert level.
Prasad has also suggested that future vaccine updates should require longer trials and more extensive data, which could slow updates for vaccines such as flu shots.
The FDA has not yet said whether a black box warning would apply to all COVID-19 vaccines, to specific age groups, or whether the proposal will go before an advisory committee. In short, the plan is not final yet and could still change, but it may be announced by the end of the year.
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