FDA Panel Backs Pfizer’s Maternal RSV Vaccine Despite Safety Concerns

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1. Pfizer's maternal RSV vaccine receives support from the FDA's advisory committee despite safety concerns.

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2. The committee votes in favor of the vaccine's efficacy and safety, with a 10-4 verdict.

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3. The vaccine, known as Abrysvo, has been evaluated in five clinical trials involving over 4,100 expectant mothers.

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4. Questions were raised about the numerical imbalance in preterm births between the vaccine and placebo groups.

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5. CDC scientists and FDA presentations were given during the hearing.

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6. The CDC director expressed comfort in voting for the vaccine, highlighting the benefits for preterm infants.

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7. The FDA is expected to make a decision before the end of August.

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8. Pfizer's briefing document showed high efficacy rates for Abrysvo in preventing severe respiratory infections.

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9. Safety data indicated mild or moderate adverse reactions, with rare occurrences of serious adverse events.

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10. The FDA flagged the numerical imbalance in preterm births but acknowledged the overall favorable safety profile of the vaccine.

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