FDA Approved Vaccines for Cancer Prevention
Currently, the only FDA-approved cancer vaccines are HPV vaccines that prevent HPV-related cancers, specifically Gardasil 9 (9-valent HPV vaccine), which is the only HPV vaccine currently available in the United States.
HPV Vaccines: Evolution and Current Status
The development of HPV vaccines represents a significant advancement in cancer prevention. Over time, several HPV vaccines have been FDA-approved:
- Gardasil (quadrivalent): Protected against HPV types 6,11,16, and 18 1
- Cervarix (bivalent): Protected against HPV types 16 and 18 1
- Gardasil 9 (9-valent): Currently the only HPV vaccine available in the US, protects against HPV types 6,11,16,18,31,33,45,52, and 58 1, 2
Cancers Prevented by HPV Vaccination
HPV infection is associated with multiple cancer types:
- 91% of cervical cancers
- 69% of vulvar cancers
- 75% of vaginal cancers
- 63% of penile cancers
- 89-93% of anal cancers
- 63-72% of oropharyngeal cancers 1
Gardasil 9 provides protection against approximately 90% of HPV-related cancers when administered before HPV exposure 2.
Efficacy of HPV Vaccines
The 9-valent HPV vaccine (Gardasil 9) has demonstrated:
- 97% effectiveness against cervical, vulvar, and vaginal cancer precursor lesions related to the 5 additional HPV types it targets (beyond the original 4 types) 1, 2
- 100% efficacy (97.96% CI, 76% to 100%) for preventing HPV16/18-related CIN2/3 and adenocarcinoma in situ 2
- 100% efficacy (97.5% CI, 88% to 100%) for preventing HPV6/11/16/18-related external genital warts or vulvar/vaginal intraepithelial neoplasia 2
Population studies have shown a 64% decrease in 4vHPV type prevalence among girls 14-19 years of age and a 34% decrease among women 20-24 years of age since vaccine introduction 1.
Current Vaccination Recommendations
The Advisory Committee on Immunization Practices (ACIP) recommends:
Routine vaccination: For all children at ages 11-12 years (can start as early as age 9) 1, 2
Dosing schedule:
Catch-up vaccination: Complete through age 26 years for those not adequately vaccinated earlier 1, 2
Adults aged 27-45 years: Not routinely recommended but may be considered through shared clinical decision-making based on risk factors 1, 2
Important Clinical Considerations
- Timing is critical: Vaccination is most effective when administered before exposure to HPV (before onset of sexual activity) 2
- No pre-vaccination testing needed: No HPV DNA testing, antibody screening, or Pap testing is required before vaccination 2
- Prophylactic, not therapeutic: The vaccine prevents new HPV infections but does not treat existing infections or HPV-related diseases 2
- Continued screening necessary: Regular cervical cancer screening should continue as recommended regardless of vaccination status 2
Special Populations
- Pregnant individuals: Should delay vaccination until after pregnancy 2
- Breastfeeding individuals: Can receive HPV vaccine without restrictions 2
- Immunocompromised individuals: Should receive a 3-dose schedule regardless of age 2
- Men who have sex with men: Recommended to receive HPV vaccination through age 26 2
Safety Profile
After more than 100 million doses given worldwide, HPV vaccination has demonstrated an excellent safety profile 3. The most common side effect is headache, occurring in up to 50% of patients. Syncope has been reported, so patients should be observed for 15 minutes following administration 1.
Limitations and Future Directions
Despite the proven efficacy of HPV vaccines in preventing cancer, vaccination rates remain suboptimal. Approximately 49% of adolescents aged 13-17 years have received the recommended number of doses, with about 66% having started the series 1.
Currently, no other cancer vaccines beyond HPV vaccines have received FDA approval for cancer prevention. Research continues on developing additional preventive cancer vaccines 4.