Safety Concerns Over Merck's HPV Vaccine Gardasil Unfounded, CDC Officials Say

Main Category: Cervical Cancer / HPV Vaccine
Article Date: 10 Jun 2008 - 6:00 PDT

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Safety concerns over Merck's human papillomavirus vaccine Gardasil are unfounded, and reports of serious adverse events are unrelated to the vaccine, CDC officials recently said, the Dallas Morning News reports. According to the Morning News, about 5,000 reports have been filed by the public through a CDC- and FDA-administered database that monitors the safety of vaccines after they are licensed (Meyers, Dallas Morning News, 6/6).

Gardasil is approved by FDA for use by girls and women ages nine to 26. The vaccine in clinical trials has been shown to prevent infection with HPV strains 16 and 18, which together cause about 70% of cervical cancer cases, and to prevent infection with HPV strains 6 and 11, which cause about 90% of genital warts cases (Daily Women's Health Policy Report, 3/21).

John Iskander -- acting director of the Immunization Safety Office at CDC, which runs the database along with FDA -- said that the "safety of the vaccine is being very closely monitored," adding that fainting has been the strongest negative response to Gardasil. "There certainly have been high-profile suspected side effects, some reports of deaths," Iskander said, adding that those reports "have been investigated, and they don't appear to have been causally related." CDC's recommendations have not changed, and the vaccine will remain available, he said.

Barbara Loe Fisher -- co-founder and president of the National Vaccine Information Center, which has started warning about the possibility of adverse reactions to Gardasil -- said she is frustrated that CDC has "assumed safety" for the vaccine, which has been tested only in conjunction with the vaccine for Hepatitis B. According to the Morning News, girls often receive Gardasil at the same time as a meningitis vaccine, as well as a new booster that immunizes against tetanus, diphtheria and pertussis. Fisher said, "Not only was Gardasil put on the fast track and licensed quickly, but to say safety is assumed and you can give any vaccine with it is even more shocking." The Morning News mentions the case of a 14-year-old Dallas resident who had headaches and fainted before suffering a seizure and being diagnosed with epilepsy and who believes her symptoms are connected to the vaccine.

Joseph Bocchini, chair of the Committee on Infectious Diseases for the American Academy of Pediatrics, said, "From the data, we already know (the vaccines) would not be expected to interfere with each other in terms of antibody or safety." He added, "If we look at the number of doses given [versus] the reports, it's very clear that there are significant benefits that far outweigh potential risks at this time." Jennifer Allen, a spokesperson for Merck, on Thursday said that the company has conducted clinical trials for 10 years and that it remains confident in the vaccine (Dallas Morning News, 6/6).

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