FDA grants priority review for Pfizer’s RSV vaccine candidate for older adults
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The FDA has granted priority review to a biologics license application for Pfizer’s respiratory syncytial virus vaccine candidate, RSVpreF, for older adults, according to the company.
“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,” Annaliesa Anderson, PhD, senior vice president and chief scientific officer of vaccine research and development at Pfizer, said in a press release. “The FDA’s acceptance of the [biologics license application (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 or older.
Based on results that Healio covered in August, the vaccine demonstrated 66.7% (96.66% CI, 28.8%-85.8%) efficacy against RSV-associated lower respiratory tract illness and 85.7% (96.66% CI, 32%-98.7%) efficacy against severe RSV-associated lower respiratory tract illness. Additionally, the trial showed that the vaccine was well-tolerated with no safety concerns, according to Pfizer.
The CDC estimates that RSV results in up to 120,000 hospitalizations and 10,000 deaths among older adults in the United States each year.
Despite this burden, there are currently no approved prophylactic vaccines for RSV in older adults, with only supportive care available for patients, Pfizer noted in the release.
However, several companies are currently in late-stage development with RSV vaccines, including Bavarian Nordic, GlaxoSmithKline and Moderna.
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.
References:
- CDC. RSV in older adults and adults with chronic medical conditions. https://www.cdc.gov/rsv/high-risk/older-adults.html. Accessed Dec. 8, 2022.
- U.S. FDA accepts for priority review the Biologics License Application for Pfizer’s respiratory syncytial virus vaccine candidate for the prevention of RSV disease in older adults. https://www.pfizer.com/news/press-release/press-release-detail/us-fda-accepts-priority-review-biologics-license. Published Dec. 7, 2022. Accessed Dec. 8, 2022.
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