September 14, 2009
A Food and Drug Administration advisory panel has said GlaxoSmithKline's human papillomavirus (HPV) vaccine Cervarix is safe and effective for females ages 10-25. The committee voted 11-1 in favor of Cervarix's safety and 12-1 in support of its efficacy. FDA typically follows its expert panels' recommendations.
Some advisers called for monitoring of miscarriages, which were reported at a higher rate around the time of Cervarix vaccination compared with a control group given hepatitis A shots, while others urged tracking of muscle and neurological problems reported in a small number of patients.
"The data we have seen are reassuring," said panel member Dr. Lisa Rider of the National Institutes of Health. However, "I think we do need very strong post-marketing studies" of autoimmune conditions that could cause neurological problems, she added.
Glaxo said Cervarix's approval could come as early as this month. It would compete with Merck & Co.'s HPV vaccine Gardasil, which won FDA clearance in 2006. Though Cervarix is already approved for use in 98 countries, Glaxo's initial application for sale in the US market stalled in 2007. Both vaccines are designed to protect against strains of the STD that are responsible for the majority of cervical cancer cases. Gardasil also targets two other HPV strains that cause genital warts.
Glaxo pledged that it would track potential complications and miscarriages after FDA approval.