(Reuters) – Pfizer RSV vaccine for pregnant women showed no higher risk of pre-term or early births in a recent study. The analysis, published Monday, examined real-world data on vaccine safety and efficacy.
The vaccine Abrysvo was approved by the U.S. Food and Drug Administration last year. #PfizerRSVvaccine It targets women in their second or third trimesters to prevent RSV infections in newborns.
However, some experts had raised concerns over a higher number of pre-term births among participants taking the Pfizer shot compared to those who received a placebo in the company’s clinical trial.
Researchers from Weill Cornell Medical College in New York conducted the retrospective study in women who were 24 to 36 weeks into pregnancy, and found no significant statistical difference between the vaccinated women’s pre-term birth rate of 5.9% compared with unvaccinated women’s 6.7%.
Health regulators however recommended a narrower gestational window, said Annette Regan, from the University of San Francisco’s School of Nursing and Health Professions, in an editorial accompanying the study. #PfizerRSVvaccine
“Despite the need for further research and surveillance, results from this study should offer initial reassurance to regulators, policymakers, health care professionals, and pregnant patients,” Regan wrote in the article published in JAMA.
In most of the continental U.S., the Centers for Disease Control and Prevention (CDC) and the Advisory Committee on Immunization Practices (ACIP) recommend the vaccine for women who are 32 to 36 weeks pregnant between September and January.
The study analyzed electronic health records of women across two New York City hospitals who gave birth between September last year to late January. The Pfizer RSV vaccine study’s results provide crucial insights for healthcare professionals.
