Pfizer’s Maternal RSV Vaccine Effective at Preventing Severe Infections in Newborns, FDA Says, But Flags Potential Risk of Preterm Birth

May 16, 2023

(CNN) – Scientists have been working on an effective RSV for young children for roughly 60 years, so there’s plenty of excitement around the prospect of having a candidate get so close to the finish line. But the news isn’t all rosy. Safety data published in an agency analysis Tuesday also showed a slightly higher proportion of preterm birth in babies whose moms got the experimental RSV vaccine compared with those who got a placebo: 5.7% vs. 4.7%, respectively. The difference between the groups was not statistically significant, meaning it could have been due to chance. (Read More)