Health Officials Report Pain, Fainting Among Girls Receiving Merck's HPV Vaccine Gardasil

Main Category: Cervical Cancer / HPV Vaccine
Article Date: 08 Jan 2008 - 6:00 PDT

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U.S. health officials in recent months have received reports of pain and fainting among teenage girls who receive Merck's human papillomavirus vaccine Gardasil, the AP/International Herald Tribune reports (Stobbe, AP/International Herald Tribune, 1/3). Gardasil in clinical trials has been shown to be 100% effective in preventing infection with HPV strains 16 and 18, which together cause about 70% of cervical cancer cases, and about 99% effective in preventing HPV strains 6 and 11, which cause about 90% of genital warts cases(Daily Women's Health Policy Report, 10/5/07).

According to health officials, about 230 cases of vaccine-related fainting among girls were reported between 2005 and July 2007. Between 2002 and 2004, there were about 50 reports of fainting. About 180 of the cases reported between 2005 and July 2007 followed a dose of Gardasil, which reached the market in 2006. In addition, some girls say the pain associated with the vaccine is short-lived, but others say it is uncomfortable driving with or sleeping on the injection arm for up to a day after receiving the shot. Merck officials attribute the pain partly to the virus-like particles in the shot. Premarketing studies showed more reports of pain from Gardasil than from a placebo, and patients reported more pain when given shots with more of the particles.

However, it is unclear whether the pain associated with Gardasil is connected with the increase in reported fainting cases, Barbara Slade, an immunization safety specialist at CDC, said. Teens tend to faint from needles, so Gardasil's three-dose regimen for adolescents would be expected to cause more cases of fainting, she added.

Preliminary studies indicate 10% to 20% of adolescents have received at least one dose of Gardasil. Researchers said those rates are because of reasons other than worries about pain, including:

• The vaccine's $120 per dose cost;
  
  
• Limited initial supplies; and
  
  
• Mixed feelings among some parents and doctors about a vaccine that targets a virus that can be sexually transmitted (AP/International Herald Tribune, 1/3).

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