Doctors Say 'Wait And See' Before Prescribing Gardasil In Boys
FDA panel recommends approval for Gardasil in boys but experts advise caution.
Sept. 11, 2009 — -- Gynecologists and pediatricians largely supported a U.S. Food and Drug Administration advisory panel's vote on Wednesday to approve the vaccine Gardasil for use in males aged 9-26 to protect against genital warts. But some say a conservative approach should be taken in vaccinating boys until more evidence is in.
The panel's recommendation on Gardasil and males comes just weeks after research in the New England Journal of Medicine raised questions about the lack of clear-cut evidence that a vaccine for cervical cancer is effective. Other studies have raised questions about serious side effects from HPV vaccines like Gardasil.
The votes are non-binding, but the FDA usually follows an expert panel's advice.
Merck, the company that manufactures the vaccine, which protects against four common strains of the human papilloma virus (HPV) and has been approved to prevent genital lesions and cervical cancer in women, has consistently presented strong evidence supporting the vaccine's efficacy in males.
But lacking key information about the vaccine's duration and potential to protect against cancer in males, experts are adopting a wait-and-see attitude towards the drug until the FDA and some professional societies make formal recommendations for Gardasil use.
"[The data] looked very convincing so I wasn't really surprised that the recommendation was favorable," said Dr. Kevin Ault, associate professor of Gynecology and Obstetrics at Emory University. "It's true that [genital warts] are not cancer but they're difficult to treat and socially stigmatizing. That might be a trigger for more widespread use."