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Thursday, May 4 2023

Full Issue

FDA Clears A RSV Vaccine For The First Time

This fall, adults 60 and older in the U.S. will be able to get GSK's vaccine for respiratory syncytial virus, sold as Arexvy, after the FDA approved the shot Wednesday. Next steps are for the CDC to approve guidelines for use.

The Food and Drug Administration on Wednesday approved GSK鈥檚 vaccine for the respiratory syncytial virus, or R.S.V., for adults who are 60 and older, the company said. The vaccine, to be sold as Arexvy, appears to be the first in the world approved for sale to protect older adults from R.S.V., a potentially fatal respiratory illness. (Jewett, 5/3)

A shot developed by pharmaceutical giant GSK to protect older adults against the respiratory syncytial virus is the first to get a greenlight from the Food and Drug Administration. A Pfizer vaccine is following close behind and is under consideration for older adults and for pregnant people as a maternal vaccination that would protect newborn children. A monoclonal antibody treatment for babies, developed by Sanofi and AstraZeneca to offer vaccine-like protection during the winter RSV season, is also under consideration. (Johnson and Ovalle, 5/3)

The vaccine was authorized for people aged 60 and above by the US Food and Drug Administration, GSK said Wednesday. The UK drugmaker has touted the shot, called Arexvy to sound like RSV, as a potential blockbuster.聽(Ring, 5/3)

鈥淭his is a great first step ... to protect older persons from serious RSV disease,鈥 said Dr. William Schaffner, medical director of the National Foundation for Infectious Diseases, who wasn鈥檛 involved with its development. Next, 鈥渨e鈥檙e going to be working our way down the age ladder鈥 for what鈥檚 expected to be a string of new protections. (Neergaard, 5/3)

This is part of the Morning Briefing, a summary of health policy coverage from major news organizations. Sign up for an email subscription.
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