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The US Food and Drug Administration (FDA) has approved a new respiratory syncytial virus (RSV) vaccine for the prevention of lower respiratory tract disease caused by RSV in individuals 60 years and older.
Abrysvo is unadjuvanted and composed of two preF proteins selected to optimise protection against RSV A and B strains and was observed to be safe and effective in a Phase 3 clinical trial that included approximately 37,000 participants.
In the late-stage study, Abrysvo, was 67% effective among those aged 60 and older with two or more symptoms of RSV, and 85.7% against severe illness defined by three or more symptoms.
It comes a month after the FDA approved GSK’s Arexvy vaccine for people aged 60 and older.
RSV is a contagious virus and a common cause of respiratory illness worldwide. The virus can affect the lungs and breathing passages of an infected individual, potentially causing severe illness or death. Each year in the US it is estimated that between 60,000 and 160,000 older adults are hospitalised and between 6,000 and 10,000 die due to RSV infection.
RENOIR trial results
The FDA’s decision is based on the data from the pivotal Phase 3 clinical trial RENOIR (RSV vaccine Efficacy study iN Older adults Immunized against RSV disease). RENOIR is a global, randomised, double-blind, placebo-controlled study designed to assess the efficacy, immunogenicity, and safety of a single dose of the vaccine in adults 60 years of age and older.
RENOIR has enrolled approximately 37,000 participants, randomised to receive the vaccine or placebo in a 1:1 ratio. The results were recently published in The New England Journal of Medicine. RENOIR is ongoing, with efficacy data being collected in the second RSV season in the study.
Professor Edward E. Walsh, University of Rochester Medical Center, and principal RENOIR investigator, said: “This past RSV season demonstrated the serious consequences and potential health risks this virus poses for older adults.
“The FDA approval of Abrysvo recognises significant scientific progress, and importantly helps provide older adults potential protection against RSV and an opportunity to improve community health by helping prevent the disease.”
The US Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices (ACIP) will meet on June 21, 2023, to discuss recommendations for the appropriate use of RSV vaccines in older adults. Pending the outcome of this meeting, Pfizer anticipates supply availability in Q3 2023 ahead of the anticipated RSV season this fall.
Earlier this month, Pfizer also announced it would be initiating multiple clinical trials evaluating the vaccine in healthy children ages 2-5; children ages 5-18 with underlying medical conditions; adults ages 18-60 at high-risk due to underlying medical conditions; and adults ages 18 and older who are immunocompromised and at high-risk for RSV.
In February 2023, it was announced that the European Medicines Agency (EMA) accepted for review Pfizer’s Marketing Authorization Application (MAA) under accelerated assessment for the RSV vaccine as submitted for both older adults and maternal immunisation to help protect infants against RSV.
The formal review process by the EMA’s Committee for Medicinal Products for Human Use (CHMP) currently is ongoing.
Sanofi and partner AstraZeneca in November gained European marketing authorisation for their antibody treatment nirsevimab for preventing RSV in newborns and infants.