New shot designed to protect babies against leading cause of hospitalization is expected to be available this fall.
A Pfizer Inc. PFE, +0.95% vaccine designed to protect babies from respiratory syncytial virus, or RSV, got a green light Monday from the U.S. Food and Drug Administration — a key milestone for infant health as well as for the pharmaceutical giant’s future growth strategy.
The regulatory approval for Pfizer’s shot, called Abrysvo, comes after a decades-long quest to shield infants from the virus, which has been recognized as a major cause of hospitalizations since the 1950s, Dr. William Gruber, Pfizer’s senior vice president for vaccine clinical research and development, told MarketWatch. The maternal shot is expected to be available in the third quarter of 2023.
Pfizer has said it could see peak sales of about $2 billion from its RSV vaccine, which is part of its broader respiratory-vaccine portfolio that the company expects will help drive future growth as it loses market exclusivity for some other major products in the coming years. A CDC advisory committee on immunizations earlier this month recommended that all babies under 8 months, born during or entering their first RSV season, get a dose of Beyfortus. Children between the ages of 8 months and 19 months who are at higher risk of severe RSV should also get a Beyfortus dose for their second RSV season, the CDC said.
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