Merck's Gardasil leads to major HPV declines, but coverage holes remain: Study

In recent months, high-profile medical organizations have joined an effort to urge more vaccination against HPV, with the NCI’s Cancer Centers even calling the vaccines “tragically underused” and decrying low uptake in the U.S. as a “public health threat.” Now, those groups will have more firepower for their arguments as a new analysis--citing a decade’s worth of real-world data for Merck’s ($MRK) Gardasil--documented dramatic HPV reductions following vaccine introduction in various countries.

Led by the Royal Women’s Hospital at the University of Melbourne, Australia, the team looked at 58 studies in 9 countries from 2007 to February 2016, documenting a nearly 90% decrease in HPV incidence in countries with the highest vaccination rates. However, the team found that some countries have a ways to go with their vaccination programs, adding that “HPV-related disease remains a significant source of morbidity and mortality in developing and developed nations, underscoring the need” for such programs.

“The full public-health potential of HPV vaccination is not yet realized,” the team wrote in the abstract.

In areas with the best coverage, the analysis also found reductions of approximately 90% for genital warts, 90% for high-grade histologically proven cervical abnormalities and 60% for low-grade cytological cervical abnormalities. The data were gathered from PubMed and Embase, with the impact of Gardasil becoming “increasingly evident” over the course of the period. More than 205 million Gardasil doses had been distributed as of Dec. 31, 2015, the team noted.

The new analysis comes on the heels of an examination of HPV rates in the U.S. following vaccine introduction, released in February. That study found that HPV rates in teenage girls fell by nearly two-thirds since Gardasil’s introduction in 2006.

Also in February, all 69 of the National Cancer Institute's Cancer Centers joined together to issue a statement calling for higher uptake. ASCO, for its part, joined in the effort in May and published recommendations for oncologists to encourage vaccination.

To this point, factors hindering uptake for HPV vaccination include antivaccine campaigns, safety concerns, a sex stigma and pediatricians' reluctance to discuss the jabs. Merck's Gardasil franchise brought in $1.9 billion in sales last year, while GlaxoSmithKline's ($GSK) Cervarix reeled in about $128 million; the class was once forecast to reel in $4 billion to $10 billion by optimistic analysts.

According to the CDC’s numbers for 2015, just 40% of girls and 21% of boys in the U.S. have received the vaccines. An HHS 2020 initiative has set HPV vaccination goals for both boys and girls at 80%.

- here’s the study
- and Merck’s release

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