Federal advisors today decided not to press for the routine use of Gardasil in boys to become part of the childhood immunization schedule to protect against genital warts caused by HPV.
The Advisory Committee on Immunization Practices (ACIP), part of the CDC which convened in Atlanta, voted it is fine if parents want to get their sons vaccinated, but Gardasil will not be added to a list of routine vaccinations.
Gardasil, produced by Merck & Co. protects against four strains of humanpapillomavirus (HPV), two of which cause warts and two that cause cervical cancer.
It is recommended for use in girls as young as 11, before they become sexually active.
Earlier this month, the Food and Drug Administration (FDA) approved Gardasil for the prevention of genital warts in males ages nine through 26.
Merck had wanted the drug to be routinely recommended for boys. A federal recommendation means health insurers are more likely to pay for male vaccinations, though the “permissive use” for boys recommendation could still add some $200 to $300 million in annual Gardasil sales by 2015, reports Bloomberg.
Last year sales fell five percent.
Though genital warts are rare in men, the thinking is that males can transmit the virus to females. But the cost of giving the vaccine to males outweighs any benefit, found researchers from the Harvard School of Public Health.
Bloomberg reports that Merck took issue with the ruling Wednesday.
"Approximately 75 to 80 percent of males and females will acquire one or more types of HPV in their lives and HPV-related diseases cause significant personal and public health burden for both men and women," Merck spokeswoman Pam Eisele told Bloomberg. "As such, we believe there is value in vaccinating both young men and women with Gardasil to help protect them from certain diseases caused by HPV."
HPV is a common virus and CDC reports there are about 40 different types of genital HPV some if which can cause cervical cancer or warts. Upward of 80 percent of the adult population is exposed and the body's immune system fights off the virus.
Gardasil was first approved by FDA in 2006 for use in females, though it has not been without controversy. At least 44 girls have died shortly after receiving the vaccine as registered in the VAERS adverse reaction site within the FDA.
Meanwhile in a blow to Merck & Co, rival HPV vaccine, Cervarix (GlaxoSmithKline) received approval from ACIP for use in females. The ACIP did not issue any recommendation on which vaccine doctors should promote, though the CDC says Gardasil also protects against genital warts and cancer of the vagina and vulva.
GSK says its HPV vaccine is more effective. #