GSK’s HPV Vaccine, Cervarix, No Longer Available in US

Nick Mulcahy

October 24, 2016

GlaxoSmithKline (GSK) will no longer market its human papillomavirus (HPV) bivalent vaccine, Cervarix, in the United States, according to an industry newsletter report last week.

Cervarix protects against infection from HPV types 16 and 18.

The decision cedes the US market to Merck and its 9-valent human papillomavirus vaccine (Gardasil 9), which protects against infection from HPV types 16, 18, 31, 33, 45, 52, and 58.

"GSK recently made the decision to stop supplying Cervarix in the US due to very low market demand," a company spokesperson told the newsletter Fierce Pharma.

GSK's vaccine sales in the United States last year accounted for only £3 million of the £88 million ($107 million) worldwide sales total. The numbers are a small fraction compared to Merck's global sales total of $1.9 billion for Gardasil, according to the news story.

The GSK news came in the same week that the US Advisory Committee on Immunization Practices (ACIP) recommended a revised schedule for HPV vaccination in some children. Children and adolescents aged 15 years and younger now need just two, not three, doses of the vaccine, the ACIP said.

The ACIP is an expert panel that advises the Centers for Disease Control and Prevention (CDC). It said that the reduction in doses is appropriate because of the vaccine's enhanced immunogenicity in preteens and adolescents aged 9 to 14 years. In addition to dropping the third dose for the under-15 age group, the recommendation expands the interval from the first to the second dose from 1-2 months to 6-12 months.

CDC Director Tom Frieden, MD, MPH, approved the committee's recommendations.

Earlier this month, the US Food and Drug Administration approved adding a two-dose schedule for the 9-valent HPV vaccine Gardasil 9 for children and adolescents aged 9 to 14 years.

In 2015, about 63% of US girls and about 50% of boys received at least one HPV shot, according to data from the CDC's National Immunization Survey–Teen.

Many organizations, including the American Society of Clinical Oncology, have recommended HPV vaccination. Merck also recently initiated a direct-to-consumer ad campaign to encourage parents to have their children vaccinated.

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