Pfizer’s RSV vaccine gets USFDA approval
US pharmaceutical giant Pfizer announced recently that the United States Food and Drug Administration (FDA) has approved its respiratory syncytial virus vaccine, marketed as Abrysvo for preventing lower respiratory tract disease caused by RSV in older people of 60 years and above
In a media statement, the company informed that the FDA approval came after considering the results of the critical Phase 3 clinical trial RSV vaccine efficacy study in older adults, a global, randomised, double-blind, placebo-controlled trial that evaluated the efficacy, immunogenicity, and safety of a single dose of the vaccine in individuals 60 and older.
Commenting that a vaccine to help prevent RSV had been an elusive public health goal for more than half a century, Senior Vice President and Chief Scientific Officer, Vaccine Research and Development, Pfizer Dr Annaliesa Anderson said, “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,” she added.
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The trial enrolled approximately 37,000 participants, randomised to receive the vaccine 120 μg or placebo in a 1:1 ratio, the results of which were recently published in The New England Journal of Medicine.
Pointing out that the trial is continuing during the second consecutive RSV season, Prof Edward E. Walsh, Professor of Medicine at the University of Rochester Medical Centre and principal investigator of the trial, 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,” he added.
It may be recalled that on March 24, 2022, Pfizer announced the FDA granted Breakthrough Therapy Designation for Abrysvo for the prevention of lower respiratory tract disease caused by RSV in individuals 60 years of age and older, which was followed by the FDA’s acceptance of Abrysvo’s Biologics License Application (BLA) under priority review for older adults in November 2022.
