Committee of FDA advisers votes to recommend approval of Pfizer's maternal vaccine to protect infants from the respiratory virus known as RSV
The decision now goes to the FDA. If the agency ultimately approves the vaccine, it will be the first to protect babies against RSV – a goal scientists have been working toward for decades. The maternal vaccine is a single-dose shot would be given to a pregnant people late in pregnancy. It would trigger the development of antibodies that are passed on to the fetus and provide protection for about the first 6 months of the baby’s life.
The safety conversation One topic that came up in the FDA advisers’ discussion was the vaccine’s safety data. The most common side effects in the trials were minor and included fatigue, headache, muscle pain and pain at the injection site. The data also showed a slightly higher proportion of preterm birth in babies whose moms got the experimental RSV compared with those who got a placebo: 5.7% vs. 4.7%, respectively.
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