FDA reverses course, will review Moderna’s mRNA-based flu shot

Moderna says FDA will now consider its new mRNA flu shot after initial refusal

Moderna announced the change Wednesday, about a week after revealing that the FDA’s vaccine chief was refusing to review the new vaccine, made with Nobel Prize-winning mRNA technology.

Why Moderna Stock Just Popped

Key PointsThe FDA refused last week to consider Moderna's application to sell a flu vaccine in 2026-2027.Today, the FDA changed its mind. 10 stocks we like better than Moderna › Vaccine specialist Moderna (NASDAQ: MRNA) stock soared 5.5% through 12:55 p.m. ET Wednesday after The Wall Street Journal reported that the U.S. Food and Drug Administration will accept (note: "accept," but not automatically "approve") Moderna's application to sell a new…

US says that it will review Moderna flu vaccine it previously declined

The pharmaceutical giant expressed optimism that its new flu shot would be available this year, after approval concerns.

FDA does U-turn, will review Moderna's mRNA flu shot after shocking rejection

Trump admin's vaccine chief overruled FDA scientists to initially reject the shot.

Moderna says FDA will now review its new flu vaccine, reversing earlier decision

With the reversal from the FDA, Moderna said it is aiming to make the vaccine available for the 2026-27 flu season.

FDA to review Moderna’s mRNA flu vaccine after initial rejection

Moderna announced the Food and Drug Administration (FDA) will review its new mRNA flu vaccine, changing course less than two weeks after the agency said it refused to accept Moderna’s application.  In an announcement on Wednesday, Moderna said the FDA had reversed course and would review the vaccine with a “revised regulatory approach.” FDA says it won’t review  The process began last week, when Moderna submitted a review proposal to the FDA for…