Analysis Results Show Reductions in HPV-Related Diseases After Using Merck’s Gardasil

An updated systematic literature review examining the effectiveness and global impact of HPV vaccination using the human papillomavirus quadrivalent vaccine recombinant, types 6, 11, 16, and 18 (Gardasil, Merck) highlighted that the use of the human papillomavirus quadrivalent vaccine led to reductions in the rates of high- and low-grade cervical lesions and reductions in certain non-cervical HPV-related disease and HPV infection in men and women.

The review included 138 peer-reviewed studies published between March 1, 2016, and March 31, 2020, and details the effectiveness and impact of the human papillomavirus quadrivalent vaccine through immunization programs in 23 countries. The updated systemic literature review studies looked at the pre-specified criteria lesions, genital warts, and HPV infection, with the literature search expanded to include peer-reviewed observational studies between January 2007 and March 2020 on additional endpoints of anal and oral HPV infections, anal and oropharyngeal lesions, and recurrent respiratory papillomatosis.

Previous real-world analyses were based on 58 peer-reviewed studies published between January 1, 2007, and February 29, 2016, across Australia and New Zealand, Europe, and North America.

In the United States, the human papillomavirus quadrivalent vaccine is indicated for use in females aged 9 to 26 years for the prevention of anal, cervical, vaginal, and vulvar cancers caused by HPV types 16 and 18; genital warts caused by HPV types 6 and 11; and dysplastic or precancerous lesions caused by HPV types 6, 11, 16, and 18. Additionally, the vaccine is approved for use in males aged 9 to 26 years for the prevention of anal cancer caused by HPV types 16 and 18, for the prevention of anal dysplasia and precancerous lesions caused by HPV types 6, 11, 16, and 18, and for the prevention of genital warts caused by HPV types 6 and 11.

The human papillomavirus quadrivalent vaccine 9 is indicated in females aged 9 to 45 years for the prevention of anal, cervical, vaginal, vulvar, oropharyngeal, and other head and neck cancers caused by HPV types 16, 18, 31, 33, 45, 52, and 58; and dysplastic or precancerous lesions caused by HPV types 6, 11, 16, 18, 31, 33, 45, 52, and 58.

Further, the human papillomavirus quadrivalent vaccine 9 oropharyngeal and head and neck cancer indication are approved under accelerated approval based on effectiveness in preventing HPV-related anogenital disease.

However, the human papillomavirus quadrivalent vaccine and the human papillomavirus quadrivalent vaccine 9 do not eliminate the need for vaccine recipients to undergo screening for anal, cervical, vaginal, vulvar, oropharyngeal, and other head and neck cancers as recommended by health care providers.

Both the human papillomavirus quadrivalent vaccine and the human papillomavirus quadrivalent vaccine 9 are contraindicated in individuals with hypersensitivity, including severe allergic reactions to yeast or after a previous dose of the human papillomavirus quadrivalent vaccine or the human papillomavirus quadrivalent vaccine 9.

The most common local and systemic adverse events (AEs) in females for the human papillomavirus quadrivalent vaccine 9 were erythema, headaches, injection site pain, and swelling. In males, the most common AEs were erythema, injection site pain, and swelling. Additionally, for the human papillomavirus quadrivalent vaccine, the most common AEs were bruising, dizziness, erythema, fever, headache, injection site pain, nausea, pruritis, and swelling .

Reference

Reductions in certain types of HPV-related cervical and non-cervical diseases in women and men observed with real-world use of Merck’s Gardasil® in systematic literature review of 138 studies. Merck. November 7, 2022. Accessed November 21, 2022. https://www.merck.com/news/reductions-in-certain-types-of-hpv-related-cervical-and-non-cervical-diseases-in-women-and-men-observed-with-real-world-use-of-mercks-gardasil-in-systematic-literature-review-of-138-studies/