HPV vaccine manufacturing is expanding to meet growing global demand – precision vaccines

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(precision vaccinations)

New Jersey-based Merck today reaffirmed its commitment to providing broad equitable access to its human papillomavirus (HPV) vaccines. The Company has made significant investments in vaccine manufacturing and recently expanded its facility in Elkton, VA to support this commitment.

Merck expects HPV vaccine supply to double between 2020 and 2023 as the company continues to expand capacity at existing facilities and as new facilities come online.

Merck previously committed to expanding manufacturing capacity at existing manufacturing facilities and building new facilities to meet unprecedented global demand for its HPV vaccines.

“As we continue to ramp up production of our HPV vaccines, we are prioritizing access in countries with a high disease burden, including countries eligible for Gavi and UNICEF support,” commented Dr. Priya Agrawal, Global Lead for HPV Vaccines at Merck. in a press release dated April 4, 2022.

“Through our long-term agreement with UNICEF, we plan to provide 91.5 million doses of our HPV vaccines to Gavi-supported countries from 2021 to 2025.”

“And beyond this agreement, we’ve been offering additional doses as needed to meet growing demand.”

Merck’s lead U.S. FDA-approved HPV vaccine, GARDASIL 9, is indicated for:

  • Women aged 9 to 45 for the prevention of cervical, vulvar, vaginal, anal, oropharyngeal and other head and neck cancers caused by HPV types 16, 18, 31, 33, 45, 52 and 58 caused; cervical, vulvar, vaginal, and anal precancerous or dysplastic lesions caused by HPV types 6, 11, 16, 18, 31, 33, 45, 52, and 58; and genital warts caused by HPV types 6 and 11,
  • Men aged 9 to 45 for the prevention of anal, oropharyngeal and other head and neck cancers caused by HPV types 16, 18, 31, 33, 45, 52 and 58; anal precancerous or dysplastic lesions caused by HPV types 6, 11, 16, 18, 31, 33, 45, 52 and 58; and genital warts caused by HPV types 6 and 11.

The indication of oropharyngeal and head and neck cancer is approved under accelerated approval based on efficacy in the prevention of HPV-related anogenital disorders.

According to Merck, further approval for this indication can be made dependent on the verification and description of the clinical benefit in a confirmatory study.

In addition, vaccination with GARDASIL 9 does not obviate the need for vaccine recipients to undergo screening for cervical, vulvar, vaginal, anal, oropharyngeal and other head and neck cancers, as recommended by a healthcare provider.

Previous HPV vaccine news is posted at PrecisionVaccinations.com/HPV.

Note: The press release has been edited for clarity and manually curated for mobile readers.

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