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Pfizer says RSV vaccine candidate is safe and effective in older people

Pfizer says RSV vaccine candidate is safe and effective in older people

 


August 25, 2022

1 minute read


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Pfizer reported Thursday that its vaccine candidate against respiratory syncytial virus was nearly 86% effective in preventing serious illness in a Phase III clinical trial in older adults.

Based on data from an early analysis of the Phase 3 RENOIR trial, Pfizer said it will seek FDA approval in the fall and prepare submissions to other regulatory agencies.

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Pfizer.

RENOIR is evaluating the efficacy and safety of a single dose of RSVpreF, a bivalent RSV prefusion F vaccine candidate, in a global, randomized, double-blind, placebo-controlled trial in 37,000 adults aged 60 years and older. was evaluated.

In a planned interim analysis, the vaccine was 66.7% effective against RSV-related lower respiratory tract disease (96.66% CI, 28.8%-85.8%) and 85.7% effective against RSV-related lower respiratory tract disease ( 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 been working to develop an RSV vaccine for more than half a century, with little success. Annalisa Anderson, doctorate, Pfizer Senior Vice President, Vaccine Research and Development and Chief Scientific Officer, said: “These findings are an important step in our effort to protect against RSV disease.”

According to the CDC, RSV causes 177,000 hospitalizations and 14,000 deaths in the United States each year. According to Pfizer, there are more than 336,000 cases annually among older adults worldwide. RSV is also the most common cause of bronchiolitis and pneumonia in infants.

Despite this high burden, there are no licensed vaccines or recommended treatments for RSV. recently covered After the next years of inactivity death of two infants After receiving an investigational vaccine in 1966.

Among other vaccine candidates currently in development, Moderna announced earlier this year that it had initiated a Phase 3 trial of an investigational messenger RNA-based vaccine for RSV, building on the success of its COVID-19 mRNA vaccine. did.

References:

CDC. Respiratory syncytial virus infection (RSV) – RSV trends and surveillance. https://www.cdc.gov/rsv/research/us-surveillance.htmlAccessed 25 August 2022.

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