In June Merck, the manufacturer for the controversial Human Papilloma Virus (HPV) vaccines Gardasil® and Gardasil®9, announced the U.S. Food & Drug Administration (FDA) has granted a priority review of their request to expand the eligibility ages for Gardasil®9 to women 27-45. Since Gardasil® was first approved in June 2006, Merck has augmented their market from females ages 9-26: increasing the number of serotypes (individual virus strains) covered by the vaccine from four to nine, extending coverage to boys ages 9-15, then including men ages 16-26. However, their multiple requests to broaden the scope to ages 27-45 have been previously denied. The FDA withheld approval in 2008, citing a need for a long-term, 48-month clinical trial; when that data was presented, the FDA concluded the evidence suggested Gardasil® did not demonstrate a significant prevention of HPV-related cervical cancers in women over the age of 26. This time Merck has submitted Gardasil®9.
What does it mean that the FDA has granted a priority review, and how does that differ from a standard review? In effect, more resources will be channeled towards this particular review; a decision will be reached within a 6-month period rather than the standard 10 months. Typically this is reserved for drugs that are expected to have a large impact on disease treatment or serve an otherwise niche or novel role in the market (i.e. ebola, cholera, etc.).
As for the vaccines proponents, even the American Cancer Society is not in favor of its use in older patients. Gardasil was the first vaccine with the intent to prevent cancer; if you can’t get the support of the American Cancer Society, I would think there isn’t much chance of success. After all, their mission statement is to rid the world of cancer.
The American Cancer Society’s recommendations for HPV vaccine use
- Routine HPV vaccination for girls and boys should be started at age 11 or 12. The vaccination series can be started as early as age 9.
- HPV vaccination is also recommended for females 13 to 26 years old and for males 13 to 21 years old who have not started the vaccines, or who have started but not completed the series. Males 22 to 26 years old may also be vaccinated.*
- HPV vaccination is also recommended through age 26 for men who have sex with men and for people with weakened immune systems (including people with HIV infection), if they have not previously been vaccinated.
*For people 22 to 26 years old who have not started the vaccines, or who have started but not completed the series, it’s important to know that vaccination at older ages is less effective in lowering cancer risk.
Why should the vaccines be given to pre-teens?
The vaccines work best at this age. Research shows that younger people have a better immune response to the vaccine than those in their late teens and early 20s, and the vaccines will prevent the covered types of HPV only if they are given before exposure to the virus.
This is also an age when other vaccinations are given and when children are likely to still be getting regular medical check-ups.
What about men and women older than 26? Should they get one of the vaccines?
HPV vaccines are not approved nor recommended after age 26. While the vaccines are safe, they will not provide much, if any, benefit.
Just within a few paragraphs, a supporter of the vaccine has stated THREE times that vaccination above a certain age is unlikely to be beneficial to its recipient. In all sincerity, even if I were a proponent of the vaccination, there is no way you could get me to take an extra poke in the arm if it wasn’t likely to do me any good.
So while I don’t think it is likely to be approved, we will just have to wait and see. The FDA is due to make a decision on October 26, 2018.