By Ed Silverman
Less than a month after the FDA refused to approve the Gardasil vaccine for preventing HPV in women ages 27 to 45, Health Canada has gone in the other direction and issued an endorsement. Although Canada is a smaller market than the US, the approval is a notable step for Merck, which has been counting on a larger demographic target to boost sorely needed vaccine revenue.
In the US, Merck has been repeatedly frustrated in trying to widen the market for Gardasil. Last year, the FDA postponed a decision about approval for women ages 26 to 45 after Merck had submitted additional data. The submission was made after the agency three years ago refused to approve the vaccine for this same age bracket and, instead, sought data on a 48-month study (back story).
In Canada, Gardasil is now approved to treat girls and women nine through 45 years of age for preventing cervical cancer, vulvar and vaginal cancers, precancerous lesions and genital warts caused by HPV strains 6, 11, 16, 18. Previously, the vaccine was approved in girls and women nine through 26 (see here). The agency did not make a former announcement, although Merck issued a press release (read this).