Moderna said the Food and Drug Administration will now review its experimental mRNA flu vaccine, after the agency earlier declined to take it up. The FDA plans to make a final decision by August 5.
The FDA’s previous decision came amid HHS Secretary Robert F. Kennedy Jr.’s skepticism regarding the mRNA technology, which was used to develop the COVID-19 vaccines.
The new decision surprised investors and doctors. If approved, Moderna can offer the shot for the upcoming flu season. It seeks full approval for adults aged 50 to 64, and faster approval for those 65 and older.
The vaccine is important for the company’s growth. It wants to launch a combined Covid-flu shot and aims to break even by 2028.
CEO Stephane Bancel said the company hopes to give older Americans another option to protect themselves from the flu. Moderna’s shares rose more than 6% after the news.