MedicalResearch.com Interview with:
Pedro Moro MD MPH
Immunization Safety Office, Division of Healthcare Quality Promotion
National Center for Emerging and Zoonotic Infectious Diseases
Centers for Disease Control and Prevention
Medical Research: What is the background for this study? What are the main findings?
Dr. Moro: Gardasil® is a human papillomavirus (HPV) vaccine recommended for all girls and boys at age 11 or 12, and teens and young adults who did not get the vaccine when they were younger. Because there is limited safety data available on use of the vaccine during pregnancy, it is not currently recommended for pregnant women. However, some pregnant women will inadvertently receive Gardasil® because they do not yet know that they are pregnant at the time of vaccination.
The study reviewed non-manufacturer reports to the Vaccine Adverse Event Reporting System (VAERS) about pregnant women who received Gardasil®. VAERS is a national vaccine safety surveillance program co-administered by the Centers for Disease Control and Prevention (CDC) and the U.S. Food and Drug Administration (FDA). VAERS accepts reports of health problems that occur after any US-licensed vaccine (these are called adverse events). VAERS may also accept reports not describing any health problem but vaccination errors (for example, administration of a vaccine not recommended to a particular group of people like pregnant women). VAERS is an early-warning system and cannot generally assess if a vaccine caused an adverse event.
After reviewing all non-manufacturer reports of Gardasil vaccination during pregnancy, this study found no unexpected patterns of safety issues for pregnant woman who received Gardasil®, or for their babies. This finding is reassuring and reconfirms the safety of this vaccine for pregnant women, as was previously reported by the pregnancy registry maintained by Gardasil®’s manufacturer.
Medical Research: What should clinicians and patients take away from your report?
Dr. Moro: This study suggests that Gardasil® is safe for pregnant women.
HPV vaccines are not recommended for use in pregnant women, but if a woman learns she is pregnant after getting Gardasil®, there is no reason for concern.
Medical Research: What recommendations do you have for future research as a result of this study?
Dr. Moro: This study’s findings will serve as a baseline for future efforts to monitor the safety of Gardasil® in pregnancy. The new Gardasil 9 (human papillomavirus 9-valent vaccine) was recently licensed by FDA. Post-marketing surveillance will be conducted by CDC and FDA after the vaccine made available in the US. As inadvertent exposure during pregnancy may also occur with this vaccine, monitoring its safety in pregnant women will be an important activity conducted by CDC.