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).
However, the approval has renewed debate over the need for women up to age 45. “For a lot of the older women in that age range, the vaccine may not be at all necessary. We have to avoid calling it a cervical cancer vaccine, because there has not been enough follow up to know if it will really be changing the cancer rates, McGill University epidemiologist Abby Lippman tells The Montreal Gazette. “The benefits are still not known right now, in terms of how long protection lasts.”
Meanwhile, an advocacy group was angered and pointed to an April 6 press release from Merck that noted the ‘limitations of use and effectiveness for Gardasil was updated to state that Gardasil has not been demonstrated to prevent HPV-related CIN 2/3 (cervical intraepithelial neoplasia) or worse in women older than 26 years of age.’
“All medical consumers should be concerned and demand to see the research proving Gardasil safety and efficacy,” Leslie Carol Botha of SANEVax wrote us. “Where is the research Merck? Canadian women should be demanding to see this research as well. Obviously, Health Canada is not representing their welfare. How can the vaccine not be effective in the U.S. and yet is effective in this age group of women across our northern border? For that matter why is the vaccine not effective in 26 year olds and effective for 25 year olds?”