Pfizer's RSV vaccine rush gets FDA boost with priority review

Pfizer is rushing to get its respiratory syncytial virus (RSV) vaccine out the door and into arms. A priority review from the FDA will certainly help.

The pharma giant announced Wednesday that U.S. regulators have accepted the application for RSVpreF to prevent lower respiratory tract disease caused by RSV in people 60 years and older. The agency has also granted a coveted priority review, which means a decision on the vaccine’s approval will arrive four months earlier than normal.

That sets a decision date for May, Pfizer said. RSVpreF was previously granted a breakthrough-therapy designation for the older adult population in March.

Pfizer has put forward evidence from a phase 3 trial called RENOIR, which enrolled 37,000 people and found the vaccine outperformed placebo at protecting against RSV-associated lower respiratory tract illness. The shot also protected against more severe illness.

If approved, RSVpreF could become the first RSV vaccine for older adults. Joining Pfizer in the race for an RSV vaccine are GSK, Johnson & Johnson, Bavarian Nordic and Moderna, which all have vaccines in the works for varying populations. GSK's shot for the same over 60 population similarly was granted a priority review and has a May due date for an FDA decision

As Pfizer awaits the regulatory nod, RSV is coursing through the U.S. along with the flu and COVID-19, a situation that has been referred to as a “tripledemic.” Centers for Disease Control and Prevention Director Rochelle Walensky, M.D., said Monday that the rate of flu and RSV is higher than the year before, when many limited social interactions and masked due to the ongoing COVID-19 pandemic. She urged Americans to wear masks and get a flu shot to prevent illness over the winter.

Editor's note: This story was amended at 1:36 p.m. ET on Dec. 8 to note that GSK also has a regulatory decision due in May.