May 18 (Bloomberg) -- Merck & Co. will tell U.S. regulators today its vaccine against a sexually transmitted virus that causes cervical cancer should be given to children as well as adults.
The Gardasil vaccine would be the first to prevent human papillomavirus, which causes genital warts and cervical cancer, the No. 2 malignancy among women worldwide. Company officials said Gardasil is the most important product Merck is developing and analysts say it may generate $3 billion in annual sales.
Merck will present evidence to a government committee that the vaccine works best in youngsters before they become sexually active. The drugmaker's pitch for universal immunization as early as age nine may be a tough sell with parents worried about adding another routine childhood vaccine. Conservative groups may object that the shot isn't necessary when children are taught to abstain from pre-marital sex.
``We have invested in public affairs and consumer education more than we've done for any vaccine in the past,'' said Richard Haupt, executive medical director of Whitehouse Station, New Jersey-based Merck, in a May 11 interview. ``Once parents are educated about what the virus does and its link to cancer, it's an eye-opening experience.''
HPV is one of the most common sexually transmitted infections in the world. About 20 million people in the U.S. are infected, according to the National Institutes of Health. About 510,000 women worldwide are diagnosed with cervical cancer each year. Females in developing countries account for about 80 percent of cases.
32 Million Children
In the U.S., where Pap smear screening is widespread, about 14,000 women are diagnosed with the cancer each year and 3,900 die from it. There are 32 million pre-teens and adolescents in the U.S., according to the Census Bureau.
The Food and Drug Administration is to decide on Gardasil's approval by June 8 under a priority-review process designed to speed promising new products to market. An advisory committee of doctors and scientists meeting today in Gaithersburg, Maryland, will issue a recommendation on approval after weighing study results.
London-based GlaxoSmithKline Plc is developing a vaccine similar to Gardasil. Unlike Merck's product, the Glaxo vaccine doesn't target genital warts, which affects 5.5 million Americans each year.
Shares of Merck fell 78 cents, or 2.2 percent, to $34.34 yesterday in New York Stock Exchange composite trading. The stock has gained 4.9 percent this year while the 56-member Standard & Poor's 500 Health Care Index has lost 5 percent. Glaxo shares declined 24 pence, or 1.6 percent, to 1512 pence yesterday in London.
An FDA staff report yesterday said Gardasil appears safe and effective. The staff also found evidence that the vaccine may not be effective among women previously infected with the virus, a group representing about 6 percent of those in the studies. The staff also said five women who conceived shortly after getting the vaccine had infants with birth defects.
A three-year Merck study found that the vaccine was almost 100 percent effective against strains of the virus that cause about 70 percent of cervical cancers.
Merck's data included studies testing Gardasil in girls and women ages 9 through 26 and boys ages 9 through 15. Merck doesn't have enough data to support approval for boys, the FDA said. Separate trials for men and boys are under way.
``A vaccine for a sexually transmitted disease for an age group of children not sexually active some parents might find problematic,'' said Amanda Dempsey, a pediatrician at the University of Michigan in Ann Arbor, in a May 11 interview. She has studied parents' attitudes toward the vaccine.
Prevention for Children
Merck says its vaccine works best when given to children before they become sexually active.
``Preventing cancer in your children, I think that's going to be an important thing parents are going to want to do,'' said Eliav Barr, Merck's senior director of clinical research, in a May 11 interview.
If the vaccine is approved by the FDA, a committee of the Atlanta-based Centers for Disease Control and Prevention will recommend whether it should be given universally. The panel next meets June 29, CDC spokesman Curtis Allen said in a May 15 interview. The committee may also decide whether to recommend federal funding through the Vaccines for Children program.
The American Academy of Pediatricians would decide whether to add Gardasil to the schedule of recommended childhood and adolescent vaccinations. Individual U.S. states determine whether such a vaccine should be mandated in some way, such as requiring children or adolescents get the shot before enrolling in public schools.
Controversy Over Mandates
Merck says it supports school requirements and has already met with some state legislators and health departments to promote its HPV vaccination.
Mandating a vaccine is where conservative religious groups such as the Family Research Council and Focus on the Family draw the line on support. While meetings with Merck representatives have tempered earlier concerns that the vaccine might send the wrong ``message'' about safe sex, conservative organizations say they oppose school requirements or any legal mandate.
``We're not raising specific objections to the age group the vaccine is administered to,'' said Peter Sprigg, vice president for policy with the Washington-based Family Research Council, in a May 12 interview. ``We feel there's a strong principle of parental control that should be respected when it comes to sexual health because of its ties to moral values.''
Merck has launched a public awareness campaign through television, print and Internet ads to win over parents and young adults.
Parents also have concerns about vaccine safety, the University of Michigan's Dempsey said. She found in a study published in the May 9 issue of the journal Pediatrics that acceptance of the HPV vaccine may have more to do with ``attitudes and life experiences'' than having increased knowledge about HPV.
The company has also met extensively with physician groups at state and national levels with the hope that persuading doctors to recommend HPV vaccination will lead to agreement by more parents to inoculate their children.
``This vaccine holds remarkable promise and it will be really important for the medical community to come together to promote a unified message about whether children should receive these vaccines,'' Dempsey said.