US to Review Moderna Flu Vaccine After Previous Decline

Moderna Announces Revised Flu Vaccine Application to FDA

The pharmaceutical giant Moderna has submitted a revised application to the US Food and Drug Administration (FDA) seeking full approval for its new flu shot, which is expected to be available later this year. The company announced that the FDA had accepted the revised application, pending further review.

According to CEO Stephane Bancel, the company looks forward to making its flu vaccine available to patients aged 50-64 and those over 65, with expedited approval for the latter group. Bancel expressed gratitude for the FDA’s “engagement” on the issue.

The decision marks an abrupt reversal from the FDA’s earlier stance, which had denied Moderna’s application to review the new flu vaccine for use among older adults. The company had previously stated that the agency’s rejection was “inconsistent with previous written communications.”

Moderna undertook a 40,000-person clinical trial focused on adults aged 50 and older, which concluded that its new vaccine was more effective than a standard shot. In response to the FDA’s initial rejection, Moderna agreed to conduct another study once the new flu shot is available.

The FDA aims to reach a decision on the revised application by August 5. The company’s flu shot utilizes mRNA technology, which has been subject to criticism from some quarters.

Source: Al Jazeera