FDA expands HPV vaccine use to older men and women

October 8 (UPI) – The US Food and Drug Administration has extended the use of Gardasil 9 – an HPV vaccine – to women and men aged 27 to 45 years.

The US agency, which made the announcement Friday, approved the use of Gardasil 9 in men and women aged 9 to 26 in 2014. The vaccine is manufactured by Merck, Sharp & Dohme Corp., a subsidiary from Merck & Co., Inc.

The approval "represents an important opportunity to contribute to the prevention of HPV-related diseases and cancers in a broader age group," said Dr. Peter Marks, Director of the FDA's Center for Biologics Evaluation and Research, in a statement.

The vaccine prevents cancers and diseases caused by the nine types of human papillomavirus.

Nearly 80 million people – about one in four – are currently infected in the United States. Approximately 12,000 women are diagnosed with cervical cancer and about 4,000 die each year from cancer caused by certain HPV viruses. HPV viruses are associated with many other forms of cancer in both men and women.

According to the CDC, the vaccine could prevent more than 90% of these cancers, or 31,200 cases per year, from developing.

In 2006, the FDA approved Gardasil to prevent certain cancers and diseases caused by four types of HPV. It is no longer distributed in the United States because a new version of the vaccine, Gardasil 9, covers the same four types of HPV and five other types. The results of clinical trials from the previous version, however, remain relevant.

A trial followed approximately 3,200 women aged 27 to 45 for an average of 3.5 years. Gardasil has been found to be 88% effective in preventing a combined endpoint of persistent infection, genital warts, vulvar and vaginal precancerous lesions, precancerous cervical lesions and cervical cancer-related the types of HPV covered by the vaccine.

In addition, 150 men between the ages of 27 and 45 received 3-dose Gardasil treatment over a 6-month period, and this treatment was equally effective.

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 given the vaccine priority priority review status, making it easier and faster to review medical products in the event of a serious or life-threatening illness.