In anticipation of their October 26th deadline, the U.S. Food & Drug Administration (FDA) announced they have approved Gardasil 9 for all women and men ages 27-45. The approval comes after the revision of a long-term study of the quadrivalent version, Gardasil; even though they are not identical, Gardasil 9 is manufactured similarly and covers the same HPV strains as Gardasil and is therefore sufficiently comparable for the FDA.
The study included 3253 women 27-45 years old, looking at serotypes -6, -11, -16, and -18; participants took all three doses within the recommended 12-month time frame and were negative for all four HPV strains being followed. They did the study in two stages – a baseline study with an average follow-up time of 3.5 years after the third dose, and a long-term study with an average follow-up time of 8.9 years after the final dose. According to the baseline study it was found Gardasil had an 87.7% efficacy rate against “persistent infection, genital warts, VIN, VaIN, vulvar cancer, vaginal cancer, cervical dysplasia (any grade CIN), AIS and cervical cancer.” However, there was no statistically significant effectiveness against CIN 2/3 dysplastic lesions. During the long-term study, there weren’t any cases of HPV-6, -11, -16, -18.
In spite of the amazing statistics presented in the study, I can’t imagine how helpful this is really going to be to the general public. Gardasil 9 is useless once you have the virus and 80% of sexually active individuals will have a strain at some point in their life, thankfully though the majority will clear up on their own without side effects. The likelihood of someone making it to this age group without having been exposed is low, especially with the current state of promiscuity in America.
Certainly, to some, this would present a better case for vaccinating early, but really my point is this likely ends up as more of a money-making scheme than actually making a difference to the general public. Too many doctors may give the vaccine to their patients after they have already been exposed, rendering the vaccine ineffective and the money wasted.
As mentioned in my previous article regarding Gardasil 9’s review status, the American Cancer Society has stated on their website that vaccination after the age of 26 will provide little, if any, benefit to the recipient. Even though they have now updated their website to reflect the recent approval, they still maintain the skepticism of the previous statement.
Why then does Merck keep pushing to expand the age group? It is certainly a question to ruminate.
If the FDA is going to allow doctors to vaccinate their older patients, it seems prudent to also make it mandatory to run a test to be sure said patient is seronegative before being vaccinated. We all know pharmaceutical companies are not altogether altruistic, so perhaps we should protect the patients’ wallets as well as their bodies. Just my two cents.