Cervarix and Pregnancy: An IntroductionCervarix® (Human Papillomavirus Bivalent [Types 16 and 18] Vaccine, Recombinant) is a vaccine approved to prevent cervical cancer and precancerous cervical lesions. It is approved for use in girls and women age 10 through 25, and, therefore, is likely to be given to some women who are unknowingly pregnant or who will become pregnant near the time of vaccination.
What Is Pregnancy Category B?The U.S. Food and Drug Administration (FDA) uses a category system to classify the possible risks to a fetus when a specific medicine is taken during pregnancy. Pregnancy Category B is given to medicines that have not been studied in pregnant humans but do not appear to cause harm to the fetus in animal studies.
Studies have shown that even very large doses of Cervarix did not cause any problems when given to pregnant rats.
During clinical trials for this vaccine, women were required to take a pregnancy test before each Cervarix dosage, and those who were pregnant were not given the vaccine. Of the women who became pregnant near the time of vaccination, a slightly increased risk of miscarriage (13.6 percent, versus 9.6 percent of women given a placebo injection) was seen, although it is unclear if this is actually related to Cervarix.
It is generally recommended that pregnant women not receive this vaccine, since the full risks are unknown. They should wait until after giving birth, if vaccination is desired.
Pregnancy and Cervarix: Final ThoughtsIf there is any chance that you may be pregnant, tell your healthcare provider before you get this vaccine. If you become pregnant near the time of vaccination, consider having your healthcare provider report your case to the Cervarix Pregnancy Registry, which was set up by the manufacturer to monitor fetal outcomes. This information will be valuable in the future for women in the same situation.
Gardasil and Pregnancy There are some situations where it is generally considered safe to take Gardasil, and pregnancy is one of them. The U.S. Food and Drug Administration has classified Gardasil as a pregnancy Category B medication, which means that it does not appear to cause harm to the fetus in animal studies. However, as the full risks of its use are unknown, Gardasil is generally not recommended during pregnancy. It is recommended to wait until after pregnancy to get the Gardasil injections. Gardasil and Pregnancy Category BThe U.S. Food and Drug Administration (FDA) uses a pregnancy category system to classify the possible risks to a fetus when a specific medicine is taken during pregnancy. Pregnancy Category B is given to medicines that have not been studied in pregnant humans, but do not appear to cause harm to the fetus in animal studies.
However, it is important to note that animals do not always respond to medicines in the same way that humans do. Therefore, a pregnancy Category B medicine may be given to pregnant women if the healthcare provider believes that the benefits to the pregnant woman outweigh any possible risks to the unborn child.
Recommendations for Using Gardasil During Pregnancy
If you are pregnant or thinking about becoming pregnant, let your healthcare provider know. Your healthcare provider will consider both the benefits and the risks of taking Gardasil during pregnancy before making a recommendation for your particular situation.
If you have been exposed to Gardasil during pregnancy, the manufacturer (Merck & Co.) has set up a Pregnancy Registry to monitor fetal outcomes. Women exposed to Gardasil during pregnancy are encouraged to report this exposure by calling (800) 986-8999.
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