TUESDAY, Nov. 24 (HealthDay News) -- There is no evidence that vaccination with the quadrivalent human papillomavirus (HPV) vaccine is harmful to the fetus, but vaccination during pregnancy is still not recommended, according to two studies published in the December issue of Obstetrics & Gynecology.
Suzanne M. Garland, M.D., of the Royal Women's Hospital in Parkville, Australia, and colleagues combined data from five randomized controlled trials comprising 20,551 women aged 15 to 45 years who received either the quadrivalent HPV vaccine or placebo, and found that among the 1,796 women in the vaccinated group and 1,824 women in the placebo group who became pregnant during the trials, there was no difference between the two groups in terms of pregnancy outcome.
Adrian Dana, M.D., of Merck Research Laboratories in West Point, Pa., and colleagues analyzed post-marketing data on pregnancy outcomes among the 451 live births resulting from 517 reports of pregnancy, and found that among women who were exposed to the quadrivalent HPV vaccine during pregnancy, the prevalence of miscarriages and major birth defects was the same as those in unexposed women.
"Because of the limited number of reports with known outcomes to date, no definitive conclusions can be made about the potential effects of exposure to HPV6/11/16/18 vaccine during pregnancy," Dana and colleagues conclude. "The HPV6/11/16/18 vaccine is not recommended for use in pregnant women. Monitoring of the safety of the vaccine in pregnancy continues and the approach is multifaceted."
Both studies were supported by Merck. Several co-authors of the Australian study received funding from Merck & Company Inc. Several co-authors of the U.S. study are employees of Merck & Company Inc.
Abstract - Garland
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Abstract - Dana
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