By Kim Polacek, APR, CPRC - June 15, 2020
Gardasil9, the human papillomavirus (HPV) vaccine manufactured by Merck, is now approved for the prevention of certain head and neck cancers. The U.S. Food and Drug Administration (FDA) granted accelerated approval last week based on preliminary data suggesting the vaccine provides protection against the types of HPV that can lead to oropharyngeal and other head and neck cancers.
Dr. Anna Giuliano, founder of the Center for Immunization and Infection Research in Cancer (CIIRC) at Moffitt Cancer Center, worked collaboratively with Merck on the concept and evidence to support vaccine prevention of head and neck cancer. She also helped design the Phase III trial that will lead to final FDA approval.
“In late 2017, my academic colleagues and I initiated discussions with the FDA regarding the design of a trial to test efficacy of Gardasil9 to prevent oropharyngeal cancer. This led to a series of events within Merck and at the FDA, resulting in this provisional approval of the vaccine to prevent oropharyngeal and other head and neck cancers. Merck recently launched the trial to test whether 6,000 men who receive the vaccine are less likely to get persistent HPV infections in their throats. The results of that trial will be shared with the FDA to validate their decision,” said Giuliano.
Oropharyngeal cancer, which includes cancers of the throat, base of tongue and tonsils, is the most common malignancy caused by HPV in the U.S. Both men and women are at risk for this type of cancer; however, men are five times more likely to be diagnosed. The Centers for Disease Control estimates 15,500 men are diagnosed with oropharyngeal cancer each year compared to 3,500 women. Unlike cervical cancer, oropharyngeal cancer does not have a reliably detected pre-cancerous lesion that can be screen for as a means of prevention.
"We have a vaccine that can be given to children as early as nine years old that will prevent boys and girls from developing up to six types of cancer."- Dr. Anna Giuliano, Founding Director, Center for Immunization and Infection Research in Cancer
Giuliano says that is why HPV vaccination is so important; it is the only reliable method to prevent oropharyngeal cancer. “This FDA approval emphasizes the importance of Gardasil9,” she said. “We have a vaccine that can be given to children as early as nine years old that will prevent boys and girls from developing up to six types of cancer.”
Giuliano and Moffitt’s CIIRC team have led the charge for gender-neutral vaccination recommendations and policies worldwide. Findings from Giuliano’s HPV vaccine studies led to the initial FDA approval of the use of Gardasil in males, as well as FDA approval to extend the age range for vaccination to 45 years for men and women.
In addition to the trial Merck is sponsoring, Giuliano is now preparing to launch a National Cancer Institute funded Phase III trial to investigate the safety and efficacy of the HPV vaccine in preventing persistent oral HPV infection, a precursor of oropharyngeal cancer, in men living with HIV in Latin America.
Giuliano will also soon open enrollment to the Merck sponsored Phase III Trial at Moffitt. Unvaccinated men ages 20 to 45 who are interested in the study can call 813-745-6996 or email firstname.lastname@example.org.