- On Wednesday, Pfizer Inc PFE detailed late-stage study results for its RSV vaccine in the New England Journal of Medicine detailing late-stage study results for its RSV vaccine.
- Pfizer in November released initial trial results on the vaccine currently under review by health regulators in the United States and Europe. The FDA is expected to decide on its use by August.
- FDA approval could make Pfizer's shot the first maternal vaccine available to prevent the disease in infants.
- Pfizer's vaccine, RSVpreF, was 81.8% effective in preventing severe lower respiratory tract illness in infants in the first 90 days of life.
- Related: FDA Fuels Respiratory Syncytial Virus Vaccine Race While Backing GSK's Candidate Soon After Pfizer's.
- Severe illness occurred within three months in 6 infants whose mothers received the vaccine, compared with 33 infants from the placebo group who contracted serious RSV infections.
- The company evaluated 3,570 infants as part of the study.
- The shot was 69.4% 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 a second main goal of reducing non-severe illness in infants.
- Non-severe lower respiratory tract illness occurred within 90 days after birth in 24 infants of women in the vaccine group and 56 infants in the placebo group, giving vaccine efficacy of 57.1%, not meeting the statistical success criterion.
- Price Action: PFE shares are up 0.77% at $41.87 during the premarket session on the last check Thursday.
© 2024 Benzinga.com. Benzinga does not provide investment advice. All rights reserved.
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