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Pfizer’s RSV vaccine candidate accepted for FDA priority review for use in older adults

A phase 3 study showed the vaccine was 85.7% effective in those with three or more symptoms


Pfizer’s Biologics License Application (BLA) for its its respiratory syncytial virus (RSV) vaccine candidate, PF-06928316 or RSVpreF, for the prevention of lower respiratory tract disease caused by RSV in adults aged 60 years and over has been accepted by the US Food and Drug Administration (FDA) for priority review.

RSV is a contagious virus characterised by several mild, cold-like symptoms. Although most people recover within a week or two, the virus can be dangerous, especially for infants and older adults.

In the US alone, it is estimated that RSV infections in older adults account for approximately 60,000 to 120,000 hospitalisations and 6,000 to 14,000 deaths each year.

There are currently no prophylactic, therapeutic, or vaccine options for older adults and the medical community is limited to offering only supportive care for adults with the illness.

Pfizer’s application is supported by results from the phase 3 RENOIR trial, a global, randomised, double-blind, placebo-controlled study designed to assess the efficacy, immunogenicity, and safety of a single dose of RSVpreF in adults aged 60 years and over.

The study showed the vaccine was 85.7% effective among participants with three or more symptoms, and 66.7% for two or more symptoms, according to an interim analysis carried out by an external data monitoring panel in August this year. Moreover, the vaccine was well-tolerated and no safety concerns were observed.

Commenting on the FDA’s decision, Annaliesa Anderson, senior vice president and chief scientific officer, vaccine research and development, Pfizer, said: “With no RSV vaccines currently available, older adults remain at-risk for RSV disease and potential severe outcomes, including serious respiratory symptoms, hospitalisation, and in some cases, even death.

"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 company also announced last month that its bivalent RSV prefusion vaccine candidate was found to be effective in preventing severe infections in infants after being given to expectant mothers, according to an interim analysis from the phase 3 MATISSE trial.

Based on these positive results, the company stopped the trial early and, at the time of the announcement, outlined its plans to submit a BLA to the FDA by the end of 2022, followed by submissions to other regulatory authorities in the coming months.

Article by
Emily Kimber

8th December 2022

From: Research, Regulatory



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