Therapy Areas: Vaccines
Reductions in Certain Types of HPV-Related Cervical and Non-Cervical Diseases in Women and Men Observed with Real-World Use of US Merck's Gardasil in Systematic Literature Review of 138 Studies
7 November 2022 - - US-based pharmaceutical company Merck (NYSE: MRK) is highlighting an updated systematic literature review examining the global impact and effectiveness of HPV vaccination using Gardasil [Human Papillomavirus Quadrivalent (Types 6, 11, 16 and 18) Vaccine, Recombinant], which was published online in the journal Expert Review of Vaccines, the company said.

This systematic review observed that use of Gardasil led to reductions in the rates of high-grade (precancerous) and low-grade cervical lesions, as well as reductions in certain non-cervical HPV-related diseases and HPV infection in women and men.

The systematic review included 138 peer-reviewed studies, published between March 1, 2016, and March 31, 2020.

It details the impact and effectiveness of Gardasil through immunization programs in 23 countries, across Africa, Asia, Europe, Australia, South America and North America and builds on a prior review of real-world data published in 2016.

The previous real-world analysis was based on 58 peer-reviewed studies published between Jan. 1, 2007, and Feb. 29, 2016, across Australia/New Zealand, Europe and North America.

Studies examining Gardasil 9 (Human Papillomavirus 9-valent Vaccine, Recombinant) were not included in this review.

In the US, Gardasil is indicated for use in females 9 through 26 years of age for the prevention of cervical, vulvar, vaginal and anal cancers caused by HPV types 16 and 18; genital warts caused by HPV types 6 and 11; and precancerous or dysplastic lesions caused by HPV types 6, 11, 16 and 18.

Gardasil is also approved for use in males 9 through 26 years of age 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.

Gardasil is contraindicated in individuals with hypersensitivity, including severe allergic reactions to yeast, or after a previous dose of Gardasil.

Gardasil is no longer marketed in the United States. Gardasil 9 was approved in the United States in 2014.

In addition to the inclusion of real-world data from more countries compared to the previous review published in 2016, longer-term effects of HPV vaccination were also observed, including reductions in certain types of cervical high-grade (precancerous) lesions.

Studies included in this review reported reductions in vaccine-targeted low-grade and high grade (precancerous) cervical lesions in females.

The greatest reductions were observed in younger age groups (14-17 years), with up to 73% reduction in CIN3+ (cervical pre-cancerous lesions) among vaccinated females.

Consistent with the previous review, declines in the incidence of anogenital warts continue to be observed within vaccine-targeted female age groups, with larger decreases (up to 88%) observed in younger age groups.

Sixteen studies reporting on non-cervical disease endpoints were also evaluated in this review. There is no routinely recommended screening for the detection of non-cervical HPV-related diseases and cancers.