Engerix-B and Pregnancy

Because it is not a "live" vaccine, Engerix-B (hepatitis B vaccine) is not expected to cause problems in a developing fetus. However, more research is needed to determine if a pregnant woman can safely receive Engerix-B. If you are pregnant and at high risk for hepatitis B, your healthcare provider may recommend that you get the vaccine, as the benefits would outweigh any risk.

Engerix-B Vaccine Information

Is Engerix-B Safe While Pregnant?

Engerix-B^® (hepatitis B vaccine) is a vaccine used to prevent hepatitis B. It is approved for all age ranges; however, it is unknown if this vaccine is safe for use in pregnant women.

What Is Pregnancy Category C?

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 C is given to medicines that have not been studied in pregnant humans but that do appear to cause harm to the fetus in animal studies.

In addition, medicines that have not been studied in any pregnant women or animals are automatically given a pregnancy Category C rating.

The effects of Engerix-B on a developing fetus are unknown. It is not expected to cause significant or serious problems, since it is a recombinant vaccine, not a live vaccine. However, because it has not been adequately studied in pregnant women, the possibility of problems cannot be ruled out.

Final Thoughts on Pregnancy and Engerix-B

Your healthcare provider may recommend that you receive Engerix-B during pregnancy if the potential benefits outweigh the risks.

For instance, this vaccine may be recommended for pregnant women who are at high risk for contracting hepatitis B. Be sure to discuss the potential benefits and risks in your unique situation with your healthcare provider.