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  • Ritu Shah

Biologics licensure application (sBLA) to add a new indication for 9-valent HPV Vaccine-FDA approved

Greetings,


Here is some information on HPV vaccine:


Last Friday,FDA approved a supplemental biologics licensure application (sBLA) to add a new indication for 9-valent HPV vaccine: prevention of oropharyngeal and other head and neck cancers caused by HPV types targeted by the vaccine.  The updated label is here:  https://www.fda.gov/media/90064/download


  • FDA based this additional indication on existing data showing prevention of HPV vaccine type persistent infections and attributable pre-cancerous lesions at genitourinary sites and also considered preliminary evidence from published studies suggesting that HPV vaccination can prevent oral persistent infection with HPV vaccine targeted types. No new studies or data beyond those previously reviewed to support indications already approved for 9vHPV were reviewed under the sBLA.

  • FDA has required that Merck conduct a post-licensure confirmatory trial of 9vHPV in adult men. Enrollment of men aged 20–45 years started in early 2020 and the trial is scheduled to be complete in 2024. The main endpoint is oral persistent infection with vaccine targeted types. The study will also evaluate immunogenicity and safety.

  • The current ACIP recommendation for HPV vaccine is routine vaccination at age 11 or 12 years and catch-up vaccination through age 26 years.  ACIP recommends shared clinical decision-making regarding potential HPV vaccination for persons aged 27 through 45 years. Modeling and cost effectiveness evaluations used for ACIP policy considerations have assumed high efficacy for prevention of cancers caused by HPV vaccine targeted types, including oropharyngeal cancer. We do not anticipate that the additional indication will impact current ACIP recommendations.





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