MD REPORTS

MD REPORTS

No 'black box' warning for Covid mRNA vaccines

The FDA has rejected its strongest safety warning for Covid mRNA vaccines despite acknowledging that children were killed by the products.

Maryanne Demasi, PhD's avatar
Maryanne Demasi, PhD
Dec 16, 2025
∙ Paid

After days of speculation, the US Food and Drug Administration (FDA) has ruled out placing a black box warning on Covid-19 mRNA vaccines — despite an internal recommendation to do so.

The decision did not come via a press release or formal FDA announcement.

Instead, it surfaced during a televised Bloomberg interview with FDA Commissioner Marty Makary, who said the agency has “no plans” to apply its strongest safety warning to Covid mRNA vaccines.

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