A vaccine designed to protect babies against RSV from birth by immunizing pregnant people has been granted priority review by the Food and Drug Administration, Pfizer announced on Tuesday, potentially bringing the game changing shot to market months ahead of schedule in a boon to parents as the race to secure approval for the first shot targeting the common, but potentially lethal, infection intensifies.
Pfizer said the FDA granted the firm priority review for its vaccine candidate designed to protect newborns and infants up to six months of age against severe disease and complications from respiratory syncytial virus, known commonly as RSV.
The decision means the agency aims to review the application within six months instead of the standard 10.
The FDA has set an “action date” on the vaccine for August, Pfizer added.
The FDA reserves priority review for drugs that promise “significant improvements” over existing efforts to combat “serious” diseases and no RSV vaccine has ever been approved in the U.S.
Annaliesa Anderson, senior vice president and chief scientific officer for vaccine research and development at Pfizer, said the maternal vaccine “would help protect infants at their first breath from the devastating effects of this infectious disease.”
WHAT TO WATCH FOR
Though Pfizer’s maternal shot could be the first RSV vaccine that protects children to be approved in the U.S., it is unlikely to be the first RSV vaccine to be approved for the disease. While researchers have struggled for decades to develop an RSV vaccine without success, pharma firms are now racing to usher a number of promising candidates through the approval process. Pfizer and GlaxoSmithKline appear to be the two top contenders for first place with vaccines designed for use in older adults, who are also at risk from RSV.
Pfizer is the only firm with a maternal vaccine—used in pregnant people to protect the infant from birth—in late stage development but it is not the only product that promises to protect young children against RSV. The FDA is currently evaluating an antibody injection from Sanofi and AstraZeneca that helps neutralize RSV in the bloodstream. The shot, not technically a vaccine, was approved in Europe in December. The FDA is expected to decide in the third quarter of 2023 and AstraZeneca said it is aiming to roll the shot out for the 2023/2024 RSV season.
RSV is a common respiratory virus that infects almost all people by the time they are two years old. For most, the infection will cause nothing more than mild, cold-like symptoms like a runny nose, coughing, sneezing and fever, according to the CDC, and will be easily shrugged off. For very young infants, older adults and people with compromised immune systems, however, RSV can be deadly. In young children, particularly those under two years of age, inflammation of the airways triggered by infection can be enough to close them off or make breathing harder. Though RSV does not kill large numbers of children in the U.S. each year—it kills between 100 and 300 children under five annually—it does hospitalize many, and the numbers can overwhelm strugglinghospitals, which happened last year. Globally, RSV is the biggest killer of young infants after malaria. The disease claims far more adult lives each year and is responsible for 14,000 deaths in adults aged 65 and over every year in the U.S.
By Robert Hart, Forbes Staff