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Pfizer Touts 85% Effectiveness Of RSV Vaccine For Adults, Seeks FDA Approval

In a Phase 3 trial, Pfizer’s vaccine demonstrated 85.7% efficacy against respiratory syncytial virus (RSV), defined by three or more symptoms in older adults.

Pfizer said Thursday that its vaccine against respiratory syncytial virus (RSV) is in late-stage studies effective in older adults and will seek approval from the FDA and other regulatory agencies around the world.

RSV is estimated About 14,000 deaths occur annually in the elderly in the United States, and treatment is limited. No vaccine.

According to an interim analysis conducted by an external data monitoring panel, the vaccine was 66.7% effective in preventing RSV-associated lower respiratory tract disease defined by 2 or more symptoms (96.66% CI, 28.8%-85.8%) .

Vaccine efficacy was 85.7% (96.66% CI, 32.0%–98.7%) for the endpoint of more severe disease, defined as 3 or more symptoms.

It was also found to be safe and well tolerated.

Phase 3 clinical trial (NCT05035212) RENOIR (iNOlder adult Immunized against RSV disease) investigated RSVpreF, a bivalent RSV prefusion F vaccine candidate, in adults 60 years and older . A bivalent vaccine candidate consists of two preF proteins selected to optimize protection against RSV A and B strains.

RENOIR is a global, randomized, double-blind, placebo-controlled study designed to evaluate the efficacy, immunogenicity and safety of a single vaccine dose. To date, approximately 37,000 participants have been enrolled and randomized to receive 120 mcg of RSVpreF or placebo in a 1:1 ratio. About 40,000 adults continue to be enrolled in the Southern Hemisphere, Pfizer said in a statement.

Each year, an estimated 336,000 older people are hospitalized for RSV worldwide, of which 177,000 occur in the United States.

The company said it plans to present the results of the interim analysis at a future medical conference and will submit the results for peer review in scientific journals.

“Scientists and researchers have been working to develop an RSV vaccine for more than half a century, with little success. Step, working with the FDA and other regulatory agencies, said Annalisa Anderson, Ph.D., senior vice president and chief scientific officer of Vaccine Research and Development at Pfizer.

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Pfizer Touts 85% Effectiveness Of RSV Vaccine For Adults, Seeks FDA Approval