Mandating the human papillomavirus
Overall, the proportions of pregnancies with an adverse outcome were comparable in subjects who received Gardasil and subjects who received placebo.
The FDA has classified the HPV vaccine as a pregnancy Category B, meaning there is no apparent harm to the fetus in animal studies.
HPV vaccines are approved for use in over 100 countries, with more than 100 million doses distributed worldwide.
Extensive clinical trial and post-marketing safety surveillance data indicate that both Gardasil and Cervarix are well tolerated and safe.
HPV vaccines have not been causally related with adverse pregnancy outcomes or adverse effects on the fetus.
However, data on vaccination during pregnancy is very limited and vaccination during the pregnancy term should be delayed until more information is available.
While there is no indication for intervention for vaccine dosages administered during pregnancy, patients and health-care providers are encouraged to report exposure to vaccines to the appropriate HPV vaccine pregnancy registry.
The FDA and CDC have reminded health care providers that, to prevent falls and injuries, all vaccine recipients should remain seated or lying down and be closely observed for 15 minutes after vaccination.
In the Gardasil clinical trials, 1,115 pregnant women received the HPV vaccine.
Gardasil has been shown to also be effective in preventing genital warts in males.
As with females, the vaccine should be administered before infection with the HPV types covered by the vaccine occurs.
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In 2018, the Food and Drug Administration released a summary basis for regulatory action and approval for expansion of usage and indication for the 9 valent HPV vaccine to include men and women 27 to 45 years of age.