A new study published in BMJ Open reported pregnant women vaccinated with Pfizer’s Abrysvo RSV vaccine were more likely to experience preterm births.
The first peer-reviewed post-authorization safety analysis of Pfizer’s respiratory syncytial virus (RSV) vaccine found that the average time between vaccination and preterm birth was three days. Two-thirds of the cases occurred within a week of immunization.
The findings confirm concerns raised during clinical trials for the drug, which also found a higher number of preterm births among women who took the vaccines.
When Pfizer reported its clinical trial results, the vaccine maker said that although there were higher preterm birth rates in the vaccine group than the placebo group, the numbers weren’t statistically significant.
Some members of the U.S. Food and Drug Administration’s (FDA) vaccine advisory committee said they had serious safety concerns about the vaccine based on the clinical trial data.
In 2023, the FDA approved the vaccine despite the concerns and even though four committee members voted against approving the drug…
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