The HPV vaccine has been around since 2006, when the FDA approved Gardasil for use in girls aged 9 through 26. That makes it nearly two decades of real-world use, with over 135 million doses distributed in the United States alone. In that time, the vaccine has evolved, expanded to cover more people, and produced striking drops in both HPV infections and cervical precancers.
The First HPV Vaccine: 2006
The original Gardasil, made by Merck, was a quadrivalent vaccine, meaning it protected against four strains of human papillomavirus. Two of those strains (types 16 and 18) cause the majority of HPV-related cancers, while the other two (types 6 and 11) cause genital warts. At launch, the vaccine was approved and recommended only for girls and young women.
Three years later, in October 2009, the FDA licensed a second HPV vaccine called Cervarix, made by GlaxoSmithKline. Cervarix targeted just two strains (types 16 and 18) and was approved for females aged 10 through 25. Having two vaccines on the market gave providers options, though Gardasil remained the more widely used product in the U.S. because of its broader strain coverage.
Expanding to Boys and Then Adults
For the first five years, HPV vaccination was recommended exclusively for females. That changed in 2011, when the CDC began recommending the vaccine for males aged 9 through 26 as well. The logic was straightforward: boys and men carry and transmit HPV, and the virus causes cancers of the throat, penis, and anus in addition to cervical cancer. Vaccinating both sexes interrupts transmission more effectively and protects everyone more broadly.
The most recent major expansion came in October 2018, when the FDA approved the current vaccine, Gardasil 9, for women and men through age 45. Gardasil 9 covers nine HPV strains rather than four, offering protection against about 90% of the strains that cause cervical cancer. It replaced the original Gardasil and is now the only HPV vaccine used in the United States.
How the Dosing Schedule Changed
When the vaccine first rolled out, everyone received three shots over six months. Research later showed that younger adolescents mount a strong enough immune response with fewer doses. Now, most people who start the series before their 15th birthday need only two doses, spaced 6 to 12 months apart. Those who begin at age 15 or older, or who are immunocompromised, still receive the original three-dose schedule.
Nearly Two Decades of Results
The population-level impact has been dramatic. CDC data comparing the pre-vaccine era (2003 to 2006) with 2015 to 2018 show an 88% decline in vaccine-targeted HPV strains among females aged 14 to 19, and an 81% decline among those aged 20 to 24. Among sexually experienced teens who were vaccinated, the prevalence of those four HPV types dropped 97%, from 19.3% down to 0.6%.
Even unvaccinated individuals have benefited. Among unvaccinated sexually experienced teens, infection rates fell 87% over the same period. This is herd protection at work: when enough people in a population are vaccinated, the virus has fewer hosts and circulates less, which shields those who haven’t been vaccinated.
The downstream effects on cervical disease are now visible, too. Among women aged 20 to 24 who were screened for cervical cancer between 2008 and 2022, rates of high-grade cervical precancers dropped by roughly 80%. Among women aged 25 to 29, precancer rates in 2022 were about 37% lower than in 2008. These precancers are the lesions that, left untreated, progress to cervical cancer, so their decline signals fewer cancers in the years ahead.
Long-Term Safety and Protection
With nearly 20 years of post-market surveillance and more than 135 million doses distributed in the U.S., the safety profile of HPV vaccines is among the most thoroughly studied of any vaccine. The CDC describes the accumulated evidence as “reassuring” across more than 15 years of active monitoring. Follow-up studies in Nordic countries have tracked vaccinated women for up to 14 years and found that protection holds strong for more than a decade without weakening.
A Quick Timeline
- 2006: Gardasil (4 strains) approved for girls and young women
- 2009: Cervarix (2 strains) approved for females aged 10 to 25
- 2011: HPV vaccination recommended for boys and young men
- 2014: Gardasil 9 (9 strains) approved, eventually replacing earlier versions
- 2016: CDC updated dosing to two shots for those starting before age 15
- 2018: FDA expanded approval through age 45 for both women and men
From a single vaccine approved for one group in 2006, HPV vaccination has grown into a routine part of adolescent healthcare for all genders, with close to two decades of evidence showing it works.