Tag: Obamacare

Did the FDA Approve a New HPV Vaccine for Adults?

What do you know about the HPV vaccine?

Hopefully you know that it can prevent cervical cancer and that lots of folks spread misinformation that is intended to confuse and scare you away from getting vaccinated and protected with it and other vaccines.

Did the FDA Approve a New HPV Vaccine for Adults?

News that the approved ages for Gardasil have been expanded will likely add to that confusion for a little while.

The FDA simply approved the expanded use of the existing Gardasil 9 vaccine – not a new vaccine.
The FDA simply approved the expanded use of the existing Gardasil 9 vaccine – not a new vaccine.

The first thing to understand is that the FDA did not approve a new Gardasil vaccine for older adults.

They very simply expanded the age recommendations for who should get the existing Gardasil 9 vaccine, which was approved back in 2014, replacing the original Gardasil vaccine, which was approved in 2006.

“The U.S. Food and Drug Administration today approved a supplemental application for Gardasil 9 (Human Papillomavirus (HPV) 9-valent Vaccine, Recombinant) expanding the approved use of the vaccine to include women and men aged 27 through 45 years.”

Why the new age indication?

“In a study in approximately 3,200 women 27 through 45 years of age, followed for an average of 3.5 years, Gardasil was 88 percent effective in the prevention of a combined endpoint of persistent infection, genital warts, vulvar and vaginal precancerous lesions, cervical precancerous lesions, and cervical cancer related to HPV types covered by the vaccine.”

But isn’t the whole point of giving the HPV vaccine to preteens that you want to get them vaccinated and protected before they are sexually active and exposed to and infected by HPV?

Sure, but if you didn’t, and unless you are sure that you have been exposed to and have been infected by all 9 types of HPV strains that Gardasil 9 protects you against, then the vaccine is still a good idea when you are older.

Except FDA approval doesn’t automatically mean that your insurance company will pay for it.

That usually comes once a vaccine is formally added to the immunization schedule by the ACIP.

“In a 2005 study, 92% of insurance plans reported following Advisory Committee on Immunization Practices recommendations to determine covered vaccines; of those, 60% could extend coverage within 3 months after issuance of recommendations and 13% in 1 month.”

Lindley et al on Financing the Delivery of Vaccines to Children and Adolescents: Challenges to the Current System

And Obamacare still requires insurance plans to provide ACIP-recommended vaccines at no charge.

Will Gardasil 9 be added to the immunization schedule for adults?

The extended age indication for Gardasil 9 will be discussed at the next ACIP meeting.
The extended age indication for Gardasil 9 will be discussed at the next ACIP meeting.

We should know sooner, rather than later. It is on the agenda for the next ACIP meeting on October 25…

More on Gardasil for Older Adults