FDA Grants Priority Review to Pfizer’s RSV Vaccine Candidate for Older Americans

The US Food and Drug Administration (FDA) today granted priority review to a biologics license application (BLA) for Pfizer’s respiratory syncytial virus (RSV) vaccine candidate, RSVpreF, for older adults, according to a company press release.

The BLA for RSVpreF was submitted for the prevention of lower respiratory tract disease caused by RSV in persons aged ≥60 years.

“With no RSV vaccines currently available, older adults remain at-risk for RSV disease and potential severe outcomes, including serious respiratory symptoms, hospitalization, and in some cases, even death,” said Annaliesa Anderson, PhD, senior vice president and chief scientific officer of vaccine research and development at Pfizer, in the statement. “The FDA’s acceptance of the BLA for our RSV vaccine candidate is an important regulatory milestone in Pfizer’s efforts to help protect older adults against RSV and demonstrates additional progress toward what has been an elusive public health goal – reducing the overall burden associated with this infectious disease.”

The BLA submission was based on findings from the phase 3 RENOIR trial—an international, randomized, double-blind, placebo-controlled study that evaluated the efficacy and safety of a single dose of RSVpreF in adults aged ≥ 60 years.

Based on results that Patient Care Online previously reported on in August, RSVpreF demonstrated 85.7% efficacy in older patients with severe RSV-associated lower respiratory tract illness (LRTI-RSV), defined by ≥3 symptoms. Also, the results showed that the vaccine was well tolerated and there were no safety concerns.

According to estimates from the US Centers for Disease Control and Prevention, RSV results in up to 120 000 hospitalizations and 10 000 deaths among older adults in the US each year. However, there are currently no approved prophylactic vaccines for RSV in older adults, with only supportive care available for patients, noted Pfizer.

The priority review designation for RSVpreF will shorten the standard BLA review period by 4 months. The FDA is expected to make a decision regarding Pfizer’s application in May 2023, which follows the FDA’s Breakthrough Therapy Designation of RSVpreF in older adults in March 2022, noted the company.