FDA approves first vaccine for pregnant women to prevent RSV in infants

23 Aug 2023 • The U.S. Food and Drug Administration (FDA) has approved Abrysvo (Respiratory Syncytial Virus Vaccine), making it the first vaccine authorized for pregnant individuals to prevent lower respiratory tract disease (LRTD) and severe LRTD caused by respiratory syncytial virus (RSV) in infants from birth through 6 months of age. The vaccine is given as a single injection into the muscle and is recommended for use between the 32nd and 36th weeks of gestation. The approval is based on ongoing international clinical studies that assessed the safety and efficacy of Abrysvo. In a clinical study involving around 3,500 vaccinated pregnant individuals and 3,500 who received a placebo, Abrysvo reduced the risk of severe LRTD by 81.8% within 90 days after birth and by 69.4% within 180 days after birth. For pregnant individuals between 32 and 36 weeks of gestation (around 1,500 receiving Abrysvo and 1,500 receiving placebo), the vaccine decreased the risk of LRTD by 34.7% and severe LRTD by 91.1% within 90 days after birth, compared to placebo. Within 180 days after birth, the risk of LRTD was lowered by 57.3%, and severe LRTD by 76.5%, with Abrysvo compared to placebo. Safety evaluations included two studies, one involving approximately 3,600 pregnant individuals and the other with around 100 participants in each group. Common side effects reported by vaccinated pregnant individuals included injection site pain, headache, muscle pain, and nausea. Source: FDA | Read full story

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