FDA Approves HPV Vaccine Gardasil 9 for Certain Head and Neck Cancers

The Food and Drug Administration (FDA) has granted accelerated approval to expand the indication of Gardasil 9 (Human papillomavirus 9-valent vaccine, recombinant), a vaccine for the prevention of HPV, to prevent oropharyngeal and other head and neck cancers caused by certain HPV types.
 
BY Ryan McDonald
PUBLISHED June 15, 2020
The Food and Drug Administration (FDA) has granted an accelerated approval to expand the indication of Gardasil 9 (Human papillomavirus 9-valent vaccine, recombinant), a vaccine for the prevention of HPV, to prevent oropharyngeal and other head and neck cancers caused by certain HPV types.

“Today’s approval for the prevention of HPV-related oropharyngeal and other head and neck cancers represents an important step in Merck’s mission to help reduce the number of men and women affected by certain HPV-related cancers,” Dr. Alain Luxembourg, director of clinical research at Merck Research Laboratories, said in a press release from the manufacturer.
Gardasil 9 is contraindicated in people who have severe allergic reactions to yeast or have experienced a hypersensitive reaction to a previous dose of Gardasil 9 or Gardasil.

The vaccine, according to the release, does not eliminate the need for recipients to undergo screening for cervical, vulvar, vaginal, anal, oropharyngeal and other head and neck cancers.

The continued approval for this expanded indication may be contingent upon confirmation of an observed benefit in an ongoing clinical trial.
 
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