August 25, 2022
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Pfizer reported Thursday that its vaccine candidate for respiratory syncytial virus was nearly 86% effective in preventing severe illness in a phase 3 clinical trial of older adults.
Based on the data, which were from an early analysis of the phase 3 RENOIR trial, Pfizer said it will seek FDA approval in the fall and will prepare submissions for other regulatory authorities.
Pfizer.
RENOIR was a global, randomized, double-blind, placebo-controlled study of 37,000 adults aged 60 years or older that assessed the efficacy and safety of a single dose of the bivalent RSV prefusion F vaccine candidate, RSVpreF.
In a planned interim analysis, the vaccine demonstrated 66.7% efficacy against RSV-associated lower respiratory tract illness (96.66% CI, 28.8%-85.8%) and 85.7% efficacy against severe RSV-associated lower respiratory tract illness (96.66% CI, 32 %-98.7%), Pfizer reported in a news release. It was also determined to be safe in this population.
“Scientists and researchers have worked to develop RSV vaccines with little success for over half a century,” Annaliesa Anderson, PhD, senior vice president and chief scientific officer of vaccine research and development at Pfizer, said in the release. “These findings are an important step in our effort to help protect against RSV disease.”
In the United States, RSV infections are responsible for 177,000 hospitalizations and 14,000 deaths in older adults each year, according to the CDC. There are more than 336,000 annual cases among older adults globally, according to Pfizer. RSV is also the most common cause of bronchiolitis and pneumonia among infants.
Despite this high burden, there are no approved vaccines or recommended treatments for RSV, although vaccine development has picked up recently after years of inactivity following the death of two toddlers after receiving an investigational vaccine in 1966.
Among other vaccines candidates currently in development, Moderna announced earlier this year that it had begun a phase 3 trial of an investigational messenger RNA-based vaccine for RSV, building on the success of its COVID-19 mRNA vaccine.
References:
CDC. Respiratory syncytial virus infection (RSV) – RSV trends and surveillance. https://www.cdc.gov/rsv/research/us-surveillance.html. Accessed on Aug 25, 2022.
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