Human papillomavirus vaccination rates still trail U.S. targets by a sizable margin, but some brand-new CDC guidelines could make a difference for Merck & Co.'s Gardasil vaccine. After an advisory committee backed cutting the dose schedule to two jabs from three, Director Tom Frieden quickly moved to make the change official.
For children 15 and under, two doses at least 6 months apart will protect against the cancer-causing virus, which is sexually transmitted, the Centers for Disease Control and Prevention said. Recipients aged 15 to 26 will still need to get three doses.
“This recommendation will make it simpler for parents to get their children protected in time,” Frieden said in a statement.
Merck and GlaxoSmithKline make the HPV vaccines Gardasil and Cervarix, respectively, but as of last month, the Merck product is the only one supplied in the U.S. market. Gardasil generated $1.9 billion in sales for Merck last year, far outearning Cervarix's $128 million. Both numbers pale in comparison to early sales estimates for the class, which ranged from $4 billion all the way up to $10 billion. U.S. uptake has been much slower than that in other countries, partly because of cultural attitudes toward sexually transmitted infections.
GSK pulled out of the U.S. HPV vaccine market recently "due to very low market demand," a spokesperson told FiercePharma.
CDC figures last year placed HPV vaccination rates at 40% for girls and 21% for boys, far short of a U.S. Department of Health and Human Services goal of 80% for both boys and girls by 2020.
According to trial data examined at several meetings of the CDC's Advisory Committee on Immunization Practices, two HPV vaccine doses in people aged 9 to 14 provided a similar or stronger immune response than three doses in people aged 15 to 26. CDC recommends children receive the vaccines at age 11 or 12.
The recommendation comes as authorities and industry work to address the low HPV vaccination rates in the U.S. due to factors including the sex stigma, safety concerns and doctors’ reluctance to give the vaccines a strong recommendation.
To the last point, the CDC is now encouraging docs to pitch the vaccines by emphasizing their cancer-fighting benefits rather than their ability to protect against sexually transmitted disease, the Wall Street Journal reports. HPV vaccines are recommended for preteens, often creating uncomfortable conversations that lead doctors to avoid strong recommendations.
Merck recently started an ad campaign that puts the onus on parents to get their children vaccinated to protect them from deadly HPV-related cancers.
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