FDA approves HPV vaccines for adults up to ages 45

October 9, 2018

The Food and Drug Administration has approved the expansion of the HPV vaccine to include men and women between 27 and 45, in an effort to protect more people from several types of cancer caused by the human papillomavirus.

The vaccine, Gardasil 9, previously was approved for people ages 9 through 26. It was administered in two doses several months apart for those who are 9 through 14, and in three doses for individuals 15 through 26. For those older than 26, the recommended regimen is three doses.

Most sexually active individuals in the US will contract with HPV in their lifetimes. Usually, the virus is cleared by the body’s immune system, but when that doesn’t occur, HPV infections can lead to cervical, anal, vaginal, penile and throat cancers.

“The approval represents an important opportunity to help prevent HPV-related diseases and cancers in a broader age range,” said Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research.

The vaccine protects from nine common HPV strains, and is most effective when administered before the initiation of sexual activity. However, data also indicate that the vaccine can benefit the older group, as while many adults have been exposed to some types of HPV, most have not been exposed to all nine types covered by the vaccine.

Merck, the vaccine manufacturer, requested the expanded age range this year. In June, the FDA granted the application priority review.

The original version of the vaccine, Gardasil, was approved by the FDA in 2006 and covered four strains of HPV. It is no longer available in the United States. Gardasil 9 was approved in 2014. The two versions are manufactured similarly and cover four of the same HPV types.

The FDA said it expanded the age approval based on the data from the original Gardasil vaccine involving 3,200 women ages 27 through 45. The data, and long-term follow-up, showed that Gardasil was effective in preventing persistent infection, genital warts, various precancerous lesions, and cancers related to HPV types covered by the vaccine.

The effectiveness for men was concluded based on the data for women, a small trial for men ages 27 through 45, and the experience of younger males.

The Centres for Disease Control and Prevention’s Advisory Committee on Immunisation Practices, which is made up of medical and public health experts who make recommendations on the use of vaccines, will review the expanded age range at its meeting and vote on it next year. If the CDC committee recommends that the older group receive the vaccine, insurance companies will most likely to cover the cost.

In August, CDC data for 2017 showed that although HPV vaccination rates are rising, the numbers are not as high as medical experts would prefer. Nearly half of adolescents ages 13 to 17 had received all the recommended doses for HPV vaccination, while two-thirds had received the first dose. For both groups, that was a 5% increase from the previous year.

According to the CDC, HPV-related cancers also are increasing. More than 43,000 people developed HPV-associated cancer in 2015, compared to about 30,000 in 1999.