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.

The federal agency tasked with regulating drugs in the United States has said it will review a flu vaccine application from the pharmaceutical giant Moderna, one week after it declined to do so in an unusual move.

Moderna announced on Wednesday that the Food and Drug Administration (FDA) had accepted a revised application seeking full approval for a new flu shot to be offered to patients between the ages of 50 and 64 and expedited approval for those over 65.

“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,” CEO Stephane Bancel said in a statement.

He also expressed thanks for the FDA’s “engagement” on the issue.

The FDA’s decision to accept Moderna’s application marked an abrupt reversal from its earlier stance. On February 10, Moderna revealed that the FDA had denied its application to review the new flu vaccine for use among older adults.