Long-Term Follow-up Data on Sustained Immunogenicity and Safety for GARDASIL®9 Published in Pediatrics
Retrieved on:
Tuesday, September 5, 2023
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The oropharyngeal and head and neck cancer indication is approved under accelerated approval based on effectiveness in preventing HPV-related anogenital disease.
Key Points:
- The oropharyngeal and head and neck cancer indication is approved under accelerated approval based on effectiveness in preventing HPV-related anogenital disease.
- Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.
- As part of the primary objective of immunogenicity, data showed sustained HPV-antibody responses at 10 years after the third dose in boys and girls.
- With the exception of cervical cancer, there is no routinely recommended screening for the detection of HPV-related cancers.