A vaccine advisory committee for the Food and Drug Administration will review whether to recommend two vaccines for respiratory syncytial virus for approval next week as pharmaceutical giant Pfizer and rival drug manufacturer GSK vie to have the first RSV vaccine to hit the U.S. market.
The Vaccines and Related Biological Products Advisory Committee, the same group that reviews COVID-19 vaccines, will consider data for Pfizer's RSV vaccine, which is administered to pregnant women to protect infants, next Tuesday, followed by GSK's shot, which is designed for use in adults 60 years and older, on Wednesday. If the panel votes in favor of recommending the vaccines, it could pave the way for full FDA approval later this year.
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RSV is a common respiratory illness that typically causes cold-like symptoms, but it can be particularly dangerous for infants and older adults. An estimated 58,000 children under 5 years old and 60,000 to 160,000 adults 65 years and older are hospitalized each year due to an RSV infection, the Centers for Disease Control and Prevention said. Right now, there is no vaccine approved for the respiratory illness in the United States.
Pfizer said Tuesday that the FDA is reviewing its maternal RSV vaccine on an expedited basis, with the agency expected to make a decision on whether to greenlight the shot in August. The vaccine was 82% effective at preventing severe disease from RSV in infants during the first 90 days of life when given to pregnant mothers in the late second or third trimester, according to a late-stage trial.
"If approved, RSVpreF would help protect infants at their first breath from the devastating effects of this infectious disease, which though well-known, has been particularly evident throughout this RSV season,” said Annaliesa Anderson, Pfizer's senior vice president and chief scientific officer on vaccine research and development.
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The FDA has also granted priority review for GSK's RSV vaccine candidate and is set to take action by May. The vaccine was shown to be 94% effective against severe lower respiratory tract disease associated with an RSV infection in adults aged 60 and older, according to trial data.
The fast-tracked development of RSV vaccine candidates follows a particularly rough respiratory season. Children's hospitals reported an early rise in respiratory diseases, including RSV, among young children last fall, overwhelming their emergency rooms and filling pediatric beds.