FDA approves Pfizer’s RSV vaccine for older adults
James Spargo | June 1, 2023 | News story | Research and Development | FDA, Infections and infestations, Pfizer, RSV, Vaccine
Global pharmaceutical company Pfizer has announced that the US Food and Drug Administration (FDA) has approved its respiratory syncytial virus (RSV) vaccine for the prevention of lower respiratory tract disease (LRTD) caused by RSV in patients aged 60 years or older.
Abrysvo is a bivalent RSV prefusion F (RSVpreF) vaccine which is unadjuvanted and composed of two preF proteins which have been chosen to optimise protection against RSV A and B strains.
The FDA’s decision was based on data from the global, randomised, double-blind, placebo-controlled phase 3 RENOIR (NCT05035212) trial, designed to assess the efficacy, immunogenicity and safety of a single dose of the vaccine. The trial is still ongoing, with interim results having been published in The New England Journal of Medicine.
Annaliesa Anderson PhD, senior vice president and CSO of Vaccine Research and Development at Pfizer, commented: “A vaccine to help prevent RSV had been an elusive public health goal for more than half a century. Today’s approval is a monumental step forward in delivering on Pfizer’s commitment to help alleviate the significant burden of RSV in higher-risk populations, which includes older adults. Abrysvo will address a need to help protect older adults against the potentially serious consequences of RSV disease. We are extremely grateful to the clinical trial participants, study investigator teams and our dedicated Pfizer colleagues for their roles in making this vaccine available.”
Edward E Walsh MD, professor of Medicine at 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. Today’s 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.”
James Spargo
Related Content
EndoCyclic New Drug application approved by US FDA for endometriosis treatment
EndoCyclic Therapeutics’ Investigational New Drug (IND) application for its lead programme, ENDO-205, has been approved …
Naobios partners with SGS to manufacture RSV challenge agent
Contract Development and Manufacturing Organisation (CDMO) Naobios has partnered with SGS, a testing, inspection and …
Canada awards CSL Seqirus with influenza pandemic vaccine contract
CSL Seqirus has been awarded a contract committing it to manufacturing and delivering influenza vaccines …
