May 18, 2006
Cervical Cancer Vaccine Faces Review
By Lisa Richwine
WASHINGTON -- A new vaccine to protect women and girls from a sexually transmitted virus that causes cervical cancer comes under scrutiny on Thursday when a U.S. advisory panel considers whether to back approval.
The vaccine, made by Merck & Co. Inc., is designed to prevent infection with common types of the human papilloma virus, or HPV, which causes warts and most cervical cancer.
The second-biggest cancer killer in women, cervical cancer is blamed for about 300,000 deaths worldwide each year, including almost 4,000 in the United States.
The shot could reduce annual deaths from the disease to about 90,000 if it were used globally, the company said in a summary released ahead of the advisory panel meeting.
"A vaccine targeting common HPV types is urgently needed," Merck said.
The Merck immunization fights four HPV types believed to cause more than 70 percent of cervical cancer and 90 percent of genital warts. Data so far show a three-dose series of shots given over six months prevented early-stage cervical cancer and precancerous lesions for at least 2.5 years without major side effects, Merck said.
The company is seeking approval to sell the vaccine, called Gardasil, based on studies in women and girls ages 9 to 26.
FDA staff who reviewed Merck's data agreed the vaccine seemed safe and effective and spotted no major safety concerns, according to an analysis released on Wednesday.
Some analysts project annual sales topping $2 billion if Gardasil wins FDA approval, which is widely expected.
A panel of outside experts is expected to vote on Thursday on whether to recommend FDA approval of Gardasil. The agency usually follows advice from its expert panels.
A final FDA decision is expected by June 8, putting Merck ahead of a potential rival vaccine by GlaxoSmithKline Plc. and its U.S. partner MedImmune.
Merck and France's Sanofi-Aventis would market Gardasil through a joint venture in Europe if it wins clearance there. Merck licensed the vaccine technology from Australian company CSL Ltd.
Gardasil is a key product for Merck as it faces thousands of lawsuits alleging harm from withdrawn arthritis drug Vioxx and upcoming generic copies of cholesterol drug Zocor.
Vaccine supporters had feared conservative groups would fight immunization for young girls against a sexually transmitted virus, but many organizations have voiced support as long as the shots are not mandatory for school attendance.
"The decision of whether to vaccinate a minor against this or other sexually transmitted infections should remain with the child's parent or guardian," Focus on the Family said in a statement.