WASHINGTON (Reuters) - Merck & Co’s Gardasil vaccine appears to be safe and effective in preventing genital warts in young men and boys, a U.S. medical reviewer said in documents released on Friday.
A U.S. Food and Drug Administration staff reviewer said the company’s data showed the vaccine, already approved for use in girls and young women, was effective in preventing the warts caused by certain strains of the human papillomavirus.
The company is seeking the FDA’s permission to market Gardasil for males between 9 and 26 years old, the same age rage currently approved for females.
The FDA released the staffer’s memo ahead of an advisory panel meeting on Wednesday to discuss whether to approve the new use. The agency usually follows its panelists’ recommendations.
The FDA posted the documents on its website here
Reporting by Susan Heavey; Editing by Lisa Von Ahn