FDA approves extensive use of Gardasil 9 to include individuals aged 27 to 45

The US Food and Drug Administration today approved an additional application for the 9-valent human recombinant papillomavirus (HPV) vaccine, expanding the approved use of the vaccine to women and men aged 27 to 45 years. Gardasil 9 prevents certain cancers and diseases caused by the nine HPV types covered by the vaccine.

"Today's approval represents an important opportunity to contribute to the prevention of HPV-related diseases and cancers in a broader age group," said Peter Marks, MD, Ph.D., director of FDA Center for Biologics Evaluation and Research. "Centers for Disease Control and Prevention have stated that HPV vaccination before being infected with the types of HPV covered by the vaccine could prevent more than 90% of these cancers, or 31,200 cases each year , to develop oneself".

According to the CDC, about 14 million Americans are infected each year with HPV; approximately 12,000 women are diagnosed and approximately 4,000 die from cervical cancer caused by some HPV viruses. In addition, HPV viruses are associated with many other forms of cancer in both men and women.

Gardasil, a vaccine approved by the FDA in 2006 to prevent certain cancers and diseases caused by four types of HPV, is no longer distributed in the United States. In 2014, the FDA approved Gardasil 9, which covers the same four types of HPV as Gardasil. as five other types of HPV. Gardasil 9 has been approved for men and women aged 9 to 26 years.

The effectiveness of Gardasil is relevant for Gardasil 9 because the vaccines are made in the same way and cover four identical types of HPV. In a study of approximately 3,200 women aged 27 to 45 years, followed for an average of 3.5 years, Gardasil was effective in preventing a combined endpoint of persistent infection, genital warts, Precancerous vulvar and vaginal lesions, precancerous cervical lesions. and cervical cancer related to the types of HPV covered by the vaccine. The approval of Gardasil 9 by the FDA in women aged 27 to 45 years is based on these findings and new data on the long-term follow-up of this study.

The efficacy of Gardasil 9 in men aged 27 to 45 is inferred from the data described above in women aged 27 to 45, as well as Gardasil efficacy data in younger men (16 to 26 years) and immunogenicity data a clinical trial in which 150 men, aged 27 to 45 years, received a 3-dose regimen of Gardasil over a 6-month period.

The safety of Gardasil 9 has been evaluated in approximately 13,000 men and women. The most commonly reported adverse reactions were pain, swelling, redness and headache at the injection site.

The FDA has granted Gardasil 9 priority review status for the application. This program facilitates and speeds up the review of medical products that deal with a serious or life-threatening illness.

The FDA has approved the approval of this supplement to the Gardasil 9 Biologics license application to Merck, Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.

The FDA, an agency of the US Department of Health and Social Services, protects public health by ensuring the safety, efficacy and safety of human and veterinary drugs, vaccines and other biological products for human use and medical devices. The agency is also responsible for the safety of food products, cosmetics, food supplements, products emitting electronic radiation and the regulation of tobacco products.

###