9-Valent HPV Vaccine Receives FDA Approval for Use Up to Age 45

On 5 October 2018, the United States Food and Drug Administration (FDA) approved a supplemental application for the 9-valent human papillomavirus (HPV) vaccine, Gardasil 9 , to include women and men aged 27 to 45.

-Related Topics:

• What Is HPV—Human Papillomavirus, and How Does It Cause Cancer? H
• PV Vaccine: The Story Behind Its Discovery

This expanded approval for the HPV vaccine is considered an important opportunity to help prevent HPV-associated diseases and cancers across a broader age range.

There are nearly 200 types of HPV, approximately 40 of which infect humans. An estimated %70-80 of all people become infected with some form of HPV at some point in their lives. These infections cause skin lesions such as warts / papillomas, precancerous changes and various cancers, particularly of the cervix and head and neck . HPV alone is estimated to account for %5-6 of all human cancers.

In the figure below, HPV-associated cancers can be seen:

HPV vaccination before HPV infection has the potential to prevent more than % 90 of these cancers and 31.200 cases annually in the United States alone.

HPV does not affect women alone; in men, it can also cause warts and cancers such as anal/anus and head and neck cancer.

First approved by the FDA in 2006, Gardasil was developed to prevent certain cancers and diseases caused by high-risk cervical cancer HPV types 6, 11, 16 and 18, as a 4-valent vaccine.

In 2014, the FDA approved coverage of the same four HPV types as Gardasil plus five additional types (31, 33, 45, 52 and 58) in Gardasil 9. Gardasil 9 had previously been approved for males and females aged 9 to 26.

According to the FDA, in a study of women aged 27 to 45 involving approximately 3200 women, with an average of 3.5 years of follow-up, Gardasil was % 88 effective in the combined prevention of persistent infection, genital warts, and vulvar and vaginal precancerous lesions.

The efficacy of Gardasil 9 in men aged 27-45 was demonstrated using data from previous studies in both this age group and younger men (aged 16-26).

For vaccination outside childhood, the recommended dose and administration schedule is 3 HPV vaccinations within 6 months.

The safety of Gardasil 9 was evaluated in a total of 13.000 men and women. The most frequently reported side effects are injection-site pain, swelling, redness and headaches.

In the figure below, the 3 types of HPV vaccine available worldwide and the HPV types they cover can be seen (Gardasil 9 is not yet available in our country).

Related Topics

Australia Is Close to Completely Eliminating This Cancer

How Safe Is the HPV Vaccine?

Can HPV Pass from Mother to Baby During Pregnancy? How Does HPV Spread, and Can It Be Prevented?