FDA approves HPV vaccine for adults up to age 45

WASHINGTON – The FDA has extended the approval of the human papillomavirus (HPV) vaccine, Gardasil 9, to men and women aged 27 to 45, the agency said on Friday.

"Today's approval represents an important opportunity to help prevent HPV-related diseases and cancers in a broader age range," said Peter Marks, MD, PhD, director of the Center for Disease Control and Prevention. evaluation and research of FDA biologics.

The CDC estimates that HPV vaccination can prevent more than 90% of HPV-related cancers, which most often include cervical and oropharyngeal cancers, as well as penile cancers, cancer, and cancer. anus, vagina and vulva.

In total, an estimated 31,000 new HPV-related cases are diagnosed in the United States each year. In women, approximately 12,000 new cases of cervical cancer are diagnosed each year and 4,000 die from it.

In 2014, the agency first approved Gardasil 9 for individuals aged 9 to 26 years. It covers nine types of HPV, seven of which can cause cancer (16, 18, 31, 33, 45, 52 and 58).

A first version of the vaccine was released in 2006 – under the name Gardasil and covering four types of HPV – for the prevention of HPV in girls and women aged 9 to 26 years. This indication was then extended to boys and men in this group. same age group.

Questions have been raised at different times about the safety of the vaccine, but most studies have shown that the vaccine is safe, including a study conducted in women in early pregnancy. The FDA has announced that the safety of Gardasil 9 has been evaluated in approximately 13,000 people, with the most common side effects being pain, swelling, headache, and redness at the injection site.

The efficacy data from the new approval come from both previous studies on the HPV 4-valent vaccine and from a study of the new 9-valent version.

In women aged 27 to 45, the vaccine was studied in approximately 3,200 women followed for an average of 3.5 years. The vaccine was 88% effective in preventing persistent infections; genital warts; precancerous cervical, vaginal and vulvar lesions; and HPV-related cervical cancers (for types covered by the vaccine).

In men aged 27 to 45, approval was based on both efficacy data for women in this age group, previous trials on boys and men over young people and on the immunogenicity data of a trial involving 150 men in this age group.

2018-10-07T08: 43: 07-0400