FDA will now review flu vaccine it had rejected

Driving the news: Moderna said on Wednesday that the review is proceeding after it met with regulators and amended its application.

• The new proposal seeks full approval for people age 50 to 64, and accelerated approval for those 65 and older, with a requirement for an additional study in older adults once the vaccine is on the market.

What they're saying: "We appreciate the FDA's engagement in a constructive Type A meeting and its agreement to advance our application for review," Moderna CEO Stéphane Bancel said in a statement.

• "Pending FDA approval, we look forward to making our flu vaccine available later this year so that America's seniors have access to a new option to protect themselves against flu."

Between the lines: The development came after FDA commissioner Marty Makary's defended the initial decision at a Tuesday event hosted by the drug industry trade group PhRMA, arguing Moderna's study design was flawed.

• But Makary sounded a conciliatory note, saying the rejection was "part of a conversation" with the company.
• "Discussions with the company led to a revised regulatory approach and an amended application, which FDA accepted," Department of Health and Human Services spokesperson Andrew Nixon said on Wednesday.
• "FDA will maintain its high standards during review and potential licensure stages as it does with all products."

Editor's note: The story has been updated with HHS comment.