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.

In that interview, Makary confirmed that the FDA's own safety and epidemiology centre had formally recommended a boxed warning — a step reserved, under FDA rules, for drugs with "special problems, particularly ones that may lead to death or serious injury."

That recommendation was ultimately rejected.