Gardasil Vaccine Now FDA Approved to Prevent Throat Cancer

On June 12, 2020, the FDA has (finally) approved an expanded indication for the Gardasil-9 vaccine for the prevention of throat and other head and neck cancers caused by the HPV virus. This vaccine was originally designed to prevent cervical cancer, but is now indicated to also prevent vulvar, vaginal, and anal cancers [link].

This FDA approval is long overdue given throat cancer due to the HPV virus is THE most common cause of throat cancer for young adults under 50 years of age... even more common than smoking. [more info]

A way to prevent not only HPV throat cancer but other HPV related oral and throat lesions is important particularly given the high prevalence of oral HPV infection in men between ages 18 - 69 years based on a population study published in October 2017.

More importantly from a public health policy perspective, it is also "contagious" in that one partner can transmit their HPV infection to their partner via sexual contact.

Here are some key statistics that the Gardasil-9 vaccine will help against.

• The overall prevalence of oral HPV infection was 11.5% in men and 3.2% in women (equating to 11 million men and 3.2 million women nationwide).
• High-risk oral HPV infection was more prevalent among men (7.3%) than women (1.4%).
• Oral HPV 16 was 6 times more common in men (1.8%) than women (0.3%) (1.7 million men vs. 0.27 million women).
• Among men and women who reported having same-sex partners, the prevalence of high-risk HPV infection was 12.7% and 3.6%, respectively.
• Among men who reported having 2 or more same-sex oral sex partners, the prevalence of high-risk HPV infection was 22.2%.
• Oral HPV prevalence among men with concurrent genital HPV infection was fourfold greater (19.3%) than among those without it (4.4%).
• Men had 5.4% greater predicted probability of high-risk oral HPV infection than women.
• The predicted probability of high-risk oral HPV infection was greatest among black participants, those who smoked more than 20 cigarettes daily, current marijuana users, and those who reported 16 or more lifetime vaginal or oral sex partners.

Beyond the obvious of avoiding high risk sexual behavior, one intervention to minimize risk of HPV infection as well as transmission between individuals is to get the HPV vaccine (i.e., Gardasil-9). Ideally, the vaccine should be given during the tween years (ages 11-12 years) BEFORE sexual activity occurs. [More Info]

Of note, there are currently 3 FDA approved HPV vaccines available for both boys and girls, but only the Gardasil-9 vaccine is specifically approved for throat cancer prevention:

• The bivalent HPV vaccine (Cervarix) which addresses HPV 16 and 18;
• The quadrivalent HPV vaccine (Gardasil) which prevents four HPV types: HPV 16 and 18, as well as HPV 6 and 11;
• And finally Gardasil 9 which prevents 9 HPV types: 6, 11, 16, 18, 31, 33, 45, 52, and 58.


References:
Oral Human Papillomavirus Infection: Differences in Prevalence Between Sexes and Concordance With Genital Human Papillomavirus Infection, NHANES 2011 to 2014. Ann Intern Med. [Epub ahead of print 17 October 2017] doi: 10.7326/M17-1363

FDA Approves Merck’s GARDASIL 9 for the Prevention of Certain HPV-Related Head and Neck Cancers. Merck Press Release. June 12, 2020.

Outcomes After Human Papillomavirus Vaccination in Patients With Recurrent Respiratory Papillomatosis. JAMA Otolaryngol Head Neck Surg. 2022;148(7):654-661. doi:10.1001/jamaoto.2022.1190.