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Pfizer’s experimental respiratory syncytial virus (RSV) vaccine is 82 percent effective in preventing severe infections in babies when given to mothers in the second half of pregnancy, according to trial details published Wednesday that confirm preliminary data from the study.
The final data from the study, which was stopped early when it was clear the vaccine was effective, was published in the New England Journal of Medicine.
Pfizer in November released the results of preliminary trials on the vaccine, which is currently being reviewed by health regulators in the United States and Europe. The US Food and Drug Administration is expected to rule on its use in August.
FDA approval could make Pfizer’s shot the first maternal vaccine available to prevent the disease in babies.
Sanofi and AstraZeneca are developing a single-dose antibody, nirsevimab, to prevent RSV in infants, which is also under FDA review.
Pfizer’s vaccine, RSVpreF, met one of the two main goals of the late-stage study. It is nearly 82 percent effective in preventing severe lower respiratory tract illness, such as very low oxygen levels or needing ventilator support, in babies in the first 90 days of life.
Pfizer said severe illness occurred within three months in six infants whose mothers received the vaccine, compared with 33 infants in the placebo group who developed serious RSV infections. The company evaluated 3,570 babies as part of the study.
The shot was 69.4 percent effective in preventing severe infections in the first 180 days. Severe illness occurred within six months in 19 infants born to mothers in the vaccine group, compared with 62 infants in the placebo group.
The shot failed to meet the second major goal of reducing non-severe disease in infants.
About 58,000 to 80,000 children younger than five years old are hospitalized for RSV infection each year in the United States, according to government data, and infants are among those most at risk for severe disease.
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