The Pregnancy Registry for GARDASIL®9 receives voluntary reports from
health care providers or from women/family members/friends about women who inadvertently
(prior to knowing they were pregnant) or purposefully (knowingly were vaccinated for protection
against HPV disease) received GARDASIL®9 during pregnancy. The women are enrolled and their
pregnancies are followed. Outcomes are obtained from participating clinicians.
GARDASIL®9 has been assigned to FDA Pregnancy Category B.
GARDASIL®9 was tested in developmental and reproductive toxicity studies in rats,
which included immunogenicity evaluation. The studies did not indicate direct or indirect harmful
effects with respect to pregnancy, fertility, embryonic/fetal development, parturition, or postnatal development.
HPV is not a teratogen, and there are no theoretical concerns or experimental data to suggest that HPV VLPs or aluminum
adjuvant affect the course of pregnancy or are teratogenic. Vaccination of pregnant subjects was prohibited in the clinical
studies for GARDASIL®9. In these clinical studies, women underwent urine or serum pregnancy testing prior to administration
of each dose of study vaccine. Thus, there are no studies that directly randomized pregnant women to receive GARDASIL®, GARDASIL® 9,
or placebo. Women who were found to be pregnant before completion of the 3- dose vaccine regimen were instructed to defer completion
of their vaccination regimen until resolution of the pregnancy.
Because there have been no adequate and well-controlled studies in pregnant women and because animal reproduction studies are not always
predictive of human response, GARDASIL®9 should be used during pregnancy only if clearly needed.
Health care providers are encouraged to report cases of prenatal exposure as early in pregnancy as possible to facilitate
the collection of prospective, unbiased information. Enroll your patient by completing the simple enrollment form available below. You will
be asked to complete a second Outcome of Pregnancy form at the end of the pregnancy. We provide you with a one-page patient consent form that
explains the Pregnancy Registry to your patient. We encourage you to review it with your patient and have her sign it before the end of her
pregnancy. All forms can be faxed (or mailed) to the Pregnancy Registry.
Criteria for enrollment include:
- A report of pregnancy from a patient or health care provider (U.S. residents only)
- Exposure to GARDASIL®9 at any time from 30 days prior to LMP through to pregnancy outcome
- Name of a health care provider (to confirm diagnoses and to obtain outcome information)
- Name of the patient or, if you wish to keep the report confidential, patient initials and one other patient identifier, like date of birth or chart number, to allow for follow-up at expected date of delivery
Information from the Registry is used to respond to inquiries from health care providers who call to request information on the use
of a product during pregnancy. Data may be published or used to update the pregnancy section of the product label, as appropriate. Dissemination
of data collected in the Registry is done without compromising individual patient confidentiality. Information from the Registry is shared, as required,
with regulatory authorities (e.g., FDA).
Reports of the aggregate data in the Registry are updated annually and are available to health care providers in the U.S. upon request.
(In countries outside of the U.S., information is available through the local Merck subsidiary). To request a report, call the 800 number below or
download and complete the attached Annual Report Request Form and fax it to the Registry. Please include your fax number and a report will be sent to
you within 3 business days.
Pregnancy Registry for GARDASIL®9