Health
RSV vaccine Abrysvo approved for high-risk adults aged 18-59
The Food and Drug Administration (FDA) has approved Abrysvo® (RS virus [RSV] Active immunization for prevention of lower respiratory tract disease (LRTD) with vaccines RSV Targeted at people ages 18 to 59 who are at high risk for LRTD due to RSV.
The expanded approval was based on data from a randomized, double-blind, placebo-controlled trial. MONeT trial (ClinicalTrials.gov identifier: NCT05842967) included 681 adults aged 18 to 59 with chronic lung, cardiovascular, kidney, liver, neurological, hematologic, or metabolic disease. Study participants were randomly assigned 2:1 to receive a single dose of Abrysvo or a placebo.
Results showed that Abrysvo met common immunogenicity endpoints and demonstrated non-inferior neutralizing responses against RSV-A and RSV-B. Phase 3 RENOIR study Abrysvo in adults over 60 years. Additionally, one month after administration of Abrysvo, RSV-A and RSV-B neutralizing titers increased by at least 4-fold compared to prevaccination.
The most common side effects reported in individuals aged 18 to 59 years were injection site pain, myalgia, joint pain, and nausea.
“RSV is a significant threat to young people with certain chronic conditions,” said Aamir Malik, Pfizer's U.S. chief commercial officer and executive vice president. “With this approval, we are proud that Abrysvo has achieved the only approval. respiratory syncytial virus vaccine It targets and expands its reach to adults aged 18 to 49 who are at high risk for the disease. Existing indications for the elderly and pregnant women”
This article was first published MPR
References:
- US FDA approves Pfizer's RSV vaccine Abrysvo® For adults ages 18-59 who are at high risk for the disease. News release. Pfizer. October 22, 2024. https://www.businesswire.com/news/home/20241018199265/en/US-FDA-Approves-Pfizer%E2%80%99s-RSV-Vaccine-ABRYSVO%C2%AE-for-Adults-Aged-18- Up to age 59, when the risk of disease increases.
- Abrisvo. Attached document. Pfizer; 2024. Accessed October 23, 2024. https://labeling.pfizer.com/ShowLabeling.aspx?id=19589.
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