06/16/2020
The FDA has approved Gardasil 9, the HPV vaccine to the list of approved applications to now include oropharyngeal head and neck cancer. This is based on data accumulated over more than a decade and a half, not done by the manufacturer, but through many incremental knowledge expanding peer reviewed published studies. A great number of these published advances in the data of what we knew about HPV and head and neck cancers were co funded by donors to the Oral Cancer Foundation, in partnership most often with Dr. Maura Gillison starting around 2003. Dr. Gillison is the person responsible in 1999 with first publishing data that showed the virus was responsible for the rapid increase in cases of oropharyngeal cancers, dramatically altering our understanding of a previously unrecognized etiology.
When the vaccine became available, we were advocates for studies to prove its safety and efficacy in males. We attended numerous meetings at the NIH / NCI, but were unable to obtain their funding for these studies to be done. The manufacturer after its introduction in 2006, was also disinclined to spend money looking at its efficacy in males, even though they are vectors of the virus to women. OCF along with another small charity for three years attended the CDC vaccine meetings advocating for it to be used on males, as untill that recommendation was obtained, doctors were using it “off label” which they were reluctant to do.
Despite cervical cancer being the main argument, we believed that the collateral benefits would be there in the cancer we represented, and that opinion was shared by most of the science community. After all, if you can’t get the virus, you can’t get the cancers the virus causes regardless of anatomical site. Here we are 15 years after the fact, with the CDC already endorsing its use in males, and we have seen its efficacy in that population proven out. The rates of infection in young men are down, just as they are in vaccinated young women. This is was a huge step in the fight against head and neck cancer. Note that through all this we received no funding from the manufacturer, nor other assistance.
Gender based vaccination for HPV was always a myopic misstep in both trial design and marketing, even if the application and argument was going to be only about cervical cancer. Elements in the head and neck community advised us we were wasting our resources and time to fight for this aspect of cervical cancer....so thing far removed from our oral cancer mission.
Credit should be given to the most prolific scientist, who year after year turned over every stone in new studies to expand the data, that has allowed the FDA to take this position, (even though it is 15 years after the fact), Dr. Maura Gillison and her colleagues. The Oral Cancer Foundation is very proud to have been part of this journey with her, and we thank our many individual private donors for helping make this all possible. For those interested in looking at a partial trail of all the science in its original published PDF format, please visit our web page at
https://oralcancerfoundation.org/research/
https://oralcancernews.org/wp/fda-approves-gardasil-9-the-hpv-vaccine-to-prevent-head-and-neck-cancer-2/
