FDA Adds Oropharyngeal Cancer Prevention as Indication for HPV Vaccine

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FDA Adds Oropharyngeal Cancer Prevention as Indication for HPV Vaccine

From ADA

US – The Federal Drug Administration has added oropharyngeal and other head and neck cancers to the list of indications for the human papillomavirus vaccine.

Merck, the manufacturer of the Gardasil 9 vaccine, requested in December 2019 that the FDA add prevention of oropharyngeal and other head and neck cancers caused by the HPV types targeted by Gardasil 9 to the vaccine’s indications. The FDA approved the request in a letter June 12.

“Oropharyngeal cancer is the most common cancer caused by HPV in the U.S., and men are five times more likely to be diagnosed than women,” said Dr. Alessandro Villa, Ph.D., chief of the Sol Silverman Oral Medicine Clinic at the University of California, San Francisco, and a consultant to the American Dental Association Council on Scientific Affairs who has worked with the ADA on HPV and oral cancer initiatives. “Prophylactic HPV vaccination represents a safe and effective tool for the prevention of oropharyngeal cancers.”

The request to add oropharyngeal cancer prevention received accelerated approval, meaning the FDA approved it based on clinical evidence that the vaccine prevents oral HPV infections, but the company still needs to study the efficacy of the vaccine in preventing oral infections in men aged 20 to 45. The Centers for Disease Control and Prevention estimates 70% of oropharyngeal cancers in the U.S. are associated with HPV.

The ADA adopted a policy in 2018 that urges dentists to support the use and administration of the HPV vaccine, recognizing it as a way to help prevent infection of the types of HPV associated with oropharyngeal cancer. The policy was the result of a proposal that included input from the Council on Scientific Affairs, the Council on Advocacy for Access and Prevention and the Council on Dental Practice. An HPV workgroup led by ADA volunteers developed an evidence-based background report to help write the policy.

ADA staff and volunteers also published an umbrella review on the safety and efficacy of the vaccine in the April issue of The Journal of the American Dental Association. Dr. Villa was lead author on the review.

“The recent FDA approval of the HPV vaccine for head and neck cancer prevention represents an important step for the dental community that has always played a pivotal role in many preventive care campaigns, including cancer prevention,” Dr. Villa said.