The FDA has approved Abrysvo (Pfizer), a respiratory syncytial virus (RSV) vaccine, for the prevention of lower respiratory tract disease (LRTD) caused by RSV in individuals ages 18 to 59. This approval marks the unadjuvanted bivalent RSV prefusion F (RSVpreF) vaccine as the first and only RSV vaccine designated for adults under 50 years of age who are at high risk for LRTD caused by RSV. 1
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The study authors noted that approximately 9.5% of Americans ages 18 to 49 have an underlying chronic medical condition that increases their risk of developing RSV-related LRTD and being hospitalized. These include obesity, diabetes, chronic obstructive pulmonary disease (COPD), heart failure, chronic kidney disease, and asthma. But that number rises to 24.3% for Americans ages 50 to 64. According to the study authors, Abrysvo may provide protection against RSV-LRTD because RSV fusion proteins are the primary target of neutralizing antibodies.
Abrysvo has previously received FDA approval for the prevention of RSV-LRTD in individuals 60 years of age and older, infants up to 6 months of age, and pregnant individuals between 32 and 36 weeks of gestational age. 2
At its June 2024 meeting, CDC’s Advisory Committee on Immunization Practices (ACIP) recommended updating its RSV vaccine recommendations for adults 75 and older and adults 60 to 74 who are at high risk for severe illness. It was resolved. R.S.V. Maternal immunization was recommended at the September 2023 ACIP meeting. 1, 3
“RSV is a significant threat to young people with certain chronic illnesses. After decades of vaccine research by the scientific community and Pfizer, we are now reducing the burden of RSV in this high-risk adult population.” “We have an opportunity to do that,” said Aamir Malik, U.S. chief commercial officer and executive vice president of Pfizer. In a news release.1
This approval follows the Phase 3 MONeT clinical trial (NCT05842967) that evaluated the safety, tolerability, and immunogenicity of Abrysvo in adults with chronic underlying health conditions who face an increased risk of RSV-related disease. Granted based on positive results. 1
Previous data showed that Abrysvo was well tolerated throughout the study; a single 120 μg dose of Abrysvo produced a long-lasting neutralizing response to protect against RSV-A and RSV-B. Ta. Two individuals showed RSV-A and RSV-B neutralizing responses. The study authors said the results were inferior to those shown in the phase 3 RENOIR study (NCT05035212), which evaluated the efficacy of Abrysvo in adults 60 years and older. 3
“We are proud that with this approval, ABRYSVO is now the only RSV vaccine targeted at adults aged 18 to 49 who are at high risk for the disease, expanding its existing indication for older adults and pregnant women.” Malik he said in a news release. .1
References 1. U.S. FDA approves Pfizer’s RSV vaccine ABRYSVO® for adults ages 18-59 who are at high risk for the disease. Pfizer. News release. October 22, 2024. Accessed October 23, 2024. https://www.pfizer.com/news/press-release/press-release-detail/us-fda-approves-pfizers-rsv-vaccine-abrysvor- Adults-ages -18.2. A single dose of Ferruggia K. Abrysvo may provide immune protection against RSV in immunocompromised patients. Pharmacy Times. August 22, 2024. Accessed October 23, 2024. https://www.pharmacytimes.com/view/single-dose-of-abrysvo-could-provide-immune-protection-against-rsv-in-immunocompromized-individuals.3. Ferruggia K. New ACIP recommendations for RSV vaccines aim to meet challenges through shared clinical decision-making. Pharmacy Times. August 30, 2024. Accessed October 23, 2024. https://www.pharmacytimes.com/view/new-acip-recommendations-for-rsv-vaccines-aim-to-solve-challenges-with-shared-clinical-decision – Under construction.
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