The proposal next will go before the FDA; approval could take months
By Physician’s Briefing Staff HealthDay Reporter
THURSDAY, May 18, 2023 (HealthDay News) — A panel of advisers to the U.S. Food and Drug Administration voted Thursday to recommend the first respiratory syncytial virus (RSV) vaccine designed to protect infants.
The independent committee of experts voted to recommend the shot for pregnant mothers at 24 to 36 weeks of gestation. The FDA still needs to grant its approval, a process that could take months. The agency is not obligated to follow its advisers’ recommendations, but it usually does.
The Pfizer-made vaccine would only be the second one ever approved in the United States for RSV, NBC News reported. A vaccine made by GlaxoSmithKline was approved for adults ages 60 years and older earlier this month. However, 11 RSV vaccines for various age groups are being tested in ongoing clinical trials.
Safety data for the infant vaccine is “generally favorable,” according to the FDA. Trial participants had a slightly elevated rate of preterm births compared with the control group, according to the news report. However, the rate was still lower than that seen in the general population. The rate of preterm births among the 7,400 trial participants was 5.7 percent for those who received the vaccine compared with 4.7 percent of those who received a placebo and 10 percent in the general population. A trial by GSK for an infant vaccine was halted last year because of a higher preterm birth rate.
In a clinical trial for the vaccine, infants had an 82 percent lowered risk for severe disease in the first three months after birth, NBC News said. That dropped to 69 percent by six months. Infants also had a 51 percent lowered risk for developing respiratory disease so severe that it required a doctor’s visit. Vaccine side effects included fatigue, headache, muscle pain, and injection site pain in pregnant women.
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