Cervarix and Pregnancy
Although the FDA considers Cervarix a pregnancy Category B medication, the full risks of using this vaccine during pregnancy are still unknown. Therefore, it's generally recommended that women who are expecting wait until after giving birth to get vaccinated. Before receiving Cervarix, tell your healthcare provider if there is any chance you could be pregnant.
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 9 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.