What vaccines are FDA (Food and Drug Administration) approved to prevent cancer?

FDA-Approved Vaccines for Cancer Prevention

The only FDA-approved vaccines specifically designed to prevent cancer are HPV vaccines (currently Gardasil 9) and Hepatitis B vaccines, which prevent HPV-associated cancers and hepatitis B-related hepatocellular carcinoma, respectively. 1, 2

HPV Vaccines

Efficacy and Cancer Prevention

• Gardasil 9 (9-valent HPV vaccine) is currently the only HPV vaccine available in the United States 1
• Protects against HPV types 6,11,16,18,31,33,45,52, and 58, which together are responsible for:
  • Approximately 90% of cervical cancers
  • 90% of genital warts (types 6 and 11)
  • Significant protection against other HPV-associated cancers 1

HPV-Associated Cancer Types Prevented

• 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

Vaccination Recommendations

• Routine vaccination for all children at ages 11-12 years (can start as early as age 9)
• 2-dose series for ages 9-14 years (0,6-12 months)
• 3-dose series for ages 15-26 years (0,1-2,6 months) and for immunocompromised persons regardless of age
• Catch-up vaccination through age 26 years for those not adequately vaccinated earlier 1

Clinical Evidence

• In HPV-naive individuals, Gardasil 9 has demonstrated 100% efficacy for preventing HPV16/18-related CIN2/3 and adenocarcinoma in situ, and 100% efficacy for preventing HPV6/11/16/18-related external genital warts 1
• Population studies have shown a 64% decrease in HPV type prevalence among girls 14-19 years of age since vaccine introduction 1

Hepatitis B Vaccines

Cancer Prevention Efficacy

• Recognized by the CDC as the first anti-cancer vaccine because it prevents primary liver cancer (hepatocellular carcinoma) 2
• Studies have demonstrated that universal childhood immunization against hepatitis B virus decreases the incidence of hepatocellular carcinoma among children 2
• In adult males, vaccination against hepatitis B virus has been shown to decrease the incidence of, and risk of developing, hepatocellular carcinoma 2

Recommendations

• Universal vaccination from birth to age 18 years
• Screening of pregnant women for hepatitis B is recommended to prevent vertical transmission 2

Important Clinical Considerations

HPV Vaccination

• HPV vaccination does not alter screening recommendations - vaccinated women should continue cervical cancer screening according to guidelines 3
• The vaccine is prophylactic, not therapeutic - it will not treat existing HPV infections but prevents new infections 1
• No pre-vaccination testing is needed before vaccination at any age 1

Special Populations

• Immunocompromised individuals should always receive a 3-dose HPV vaccine schedule regardless of age 1
• Men who have sex with men are recommended to receive HPV vaccination through age 26 1
• For cancer patients, the National Comprehensive Cancer Network (NCCN) recommends HPV vaccination for patients of all sexes up to 26 years of age and may be considered in patients up to 45 years of age 3

Therapeutic Cancer Vaccines

It's important to note that while the question focuses on preventative vaccines, there are also FDA-approved therapeutic cancer vaccines that treat existing cancers rather than prevent them:

• Sipuleucel-T (Provenge) for prostate cancer
• Talimogene laherparepvec (T-VEC/Imlygic) for melanoma
• BCG live for bladder cancer 4

However, these are treatments for existing cancers rather than preventative vaccines.