March 19, 9:52 PMVaccines ExaminerNorma Erickson
Gardasil is not recommended for use during pregnancy because there have been no adequate and well controlled studies in pregnant women.
Merck has therefore, established a Gardasil Pregnancy Registry to collect information the outcomes of pregnancies where the women were inadvertently received Gardasil at any time during their pregnancy, or up to 1 month prior to becoming pregnant.
Reproductive toxicology studies were conducted prior to the release of Gardasil to the public and, according to Merck, none of these studies showed any evidence of impaired fertility or harm to the fetus. These studies were conducted on animals. Animal studies do not necessarily predict human response.
During the human clinical trials, each subject was required to take a pregnancy test prior to each individual Gardasil innoculation. If she was found to be pregnant, she was advised to postpone further injections until the resolution of the pregnancy.
During these trials, according to Merck, 2266 women became pregnant during the trials with almost the same number in the Gardasil group as in the placebo group. Congenital anomalies occurred in both groups at a rate they say is consistent with their age group.
The criteria for inclusion in the Gardasil Pregnancy Registry is as follows: