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.

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…

FDA Agrees to Review Moderna mRNA Vaccine

The FDA has now agreed to review an application from Moderna concerning its mRNA influenza vaccine after previously denying the company’s effort. Moderna held a Type A meeting with the FDA and proposed a “revised regulatory approach for its investigational seasonal influenza vaccine candidate, mRNA-1010,” a press release explains. Under the company’s revised proposal, it now seeks full approval for adults ages 50-64 and an accelerated approval f…