Merck & Co Inc's vaccine to prevent the world's most prevalent sexually transmitted infection sailed through a panel of US health experts, despite early fears of opposition from the Christian Right that it might lead to promiscuity and a false sense of security.
The drugmaker's efforts to educate Christian groups while touting the vaccine's top selling point -- prevention of cervical cancer -- helped win them over.
But Merck may ultimately find itself at loggerheads with those same groups as it seeks to make the vaccine mandatory for school admission, a step considered key for widespread acceptance and one that many of the groups oppose.
The vaccine, known as Gardasil, with an estimated $2 billion US market potential, targets four types of sexually transmitted human papilloma virus, or HPV, which is believed to cause more than 70 percent of cervical cancer cases and 90 percent of genital warts.
"We don't think it should be made mandatory for school attendance," said Peter Sprigg, vice president of policy at the Family Research Council, who attended the Food and Drug Administration (FDA) advisory panel meeting on Thursday.
That view is shared by evangelical Christian group Focus on the Family.
"We support the widespread availability of the vaccine, but we do oppose the mandatory vaccination for entry to public school," said Linda Klepacki, an analyst for sexual health for the group.
For Gardasil to be widely adopted, Merck must first win FDA approval. Then, it must garner widespread backing from the Advisory Committee on Immunisation Practices -- a group that advises the US Centers for Disease Control and Prevention on immunisation standards. Both Merck and analysts deem widespread backing likely.
States would then consider whether it should be included in the list of vaccinations required for school admission.
"This is a disease that is completely sexually transmitted," Klepacki said, unlike the mumps or measles, which can be transmitted by casual contact. "We believe that parents should have the final say on whether to vaccinate their children." Merck faces a host of product liability lawsuits over its withdrawn arthritis drug Vioxx and imminent generic competition for its cholesterol drug Zocor, so the company has a lot riding on the success of Gardasil.
If the FDA follows the unanimous recommendation of its expert panel, which is widely expected, Merck will launch Gardasil in June.
That would give Merck at least a one-year advantage over GlaxoSmithKline Plc, which is developing its own HPV vaccine called Cervarix.
Cervical cancer is the second-most-common cause of cancer deaths world-wide. There are nearly a half million diagnoses and 240,000 deaths each year, Merck said.
Glaxo has estimated the combined global market opportunity for the new vaccines would be $4 billion to $7 billion a year by 2010.
"The market isn't really going to develop quickly until state health departments start requiring it for school age children," A.G. Edwards analyst Al Rauch said, adding that the process would take two to five years. Merckool mandate.
"Obviously, we believe school requirements are a very positive intervention because they do help to increase access on a state-by-state level to vaccines, especially for something as important as cervical cancer," Merck spokeswoman Kelly Dougherty said.
She said Merck would give state health officials data and information about the vaccine -- the same approach it used to win initial backing from Christian groups.
The Family Research Council's Sprigg said Merck met extensively with his group to address concerns that the vaccine might encourage promiscuous behaviour by providing a false sense of protection against sexually transmitted disease.
"From the material being reported thus far, we are being told that they have not found that effect," Sprigg said, adding, "We are monitoring this."
Dr Gene Rudd of the Christian Medical and Dental Associations, which also supports the vaccine but opposes school mandates, said he believes states could resolve the matter by building in some wiggle room.
"Our position is to have an easy opt out," he said. "Make it mandatory in the sense that it is generally accepted, but parents can opt out." While Merck awaits FDA approval, it is getting the word out about Gardasil. The company started seeding the US market last month with an informational advertising blitz stressing the link between HPV and cervical cancer.
Merck said it would continue its education efforts while regulatory agencies around the world review the product. A US television and print campaign, with the tagline "Tell Someone," makes no mention of the company or the vaccine, but Merck is now considering how to integrate the vaccine into its promotional materials, said Bev Lybrand, vice president of marketing.
She said the campaign was "born out of the finding that very little awareness exists among women about HPV and its consequences."
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