For a healthy 11‑ or 13‑year‑old needing HPV vaccination in the United States, what are the differences between Gardasil 9 (9‑valent HPV vaccine), Cervarix (bivalent HPV vaccine), and Cervavac (quadrivalent HPV vaccine) regarding FDA approval and dosing schedule?

HPV Vaccine Comparison: Gardasil 9, Cervarix, and Cervavac

Current U.S. Availability and FDA Approval Status

As of January 2017, Gardasil 9 (9-valent HPV vaccine) is the only HPV vaccine available in the United States, making it the sole option for HPV vaccination in this country. 1

Historical Context of U.S.-Approved Vaccines

Until 2017, three HPV vaccines were available or licensed in the United States 1:

• Cervarix (bivalent, 2vHPV) – GlaxoSmithKline product targeting HPV types 16 and 18, licensed for use in females only 1
• Gardasil (quadrivalent, 4vHPV) – Merck product protecting against HPV types 6,11,16, and 18, licensed for both females and males 1
• Gardasil 9 (9-valent, 9vHPV) – Merck product licensed in December 2014, now the exclusive U.S. vaccine 1

Cervavac is not FDA-approved or available in the United States – it appears to be a vaccine product used in other countries (likely India based on naming conventions), but it has no FDA approval status and is not part of U.S. vaccination guidelines. 2

Key Differences Between the Vaccines

HPV Type Coverage

Gardasil 9 provides the broadest protection, covering nine HPV types compared to the more limited coverage of earlier vaccines 1:

• Gardasil 9 (9vHPV): Types 6,11,16,18,31,33,45,52, and 58 1, 2

  • Protects against ~70% of cervical cancers (types 16/18) plus an additional 14% in women and 4% in men from the five additional high-risk types 1
  • Prevents ~90% of genital warts (types 6 and 11) 1

• Cervarix (2vHPV): Types 16 and 18 only 1

  • Protects against ~70% of HPV-related cancers 1
  • Does NOT protect against genital warts 3, 4
  • Demonstrated some cross-protection against HPV types 31,33, and 45 in clinical trials 3, 4

• Original Gardasil (4vHPV): Types 6,11,16, and 18 1

  • Protects against ~70% of HPV-related cancers 1
  • Prevents ~90% of genital warts 1

FDA Approval and Licensing

Gardasil 9 received progressive FDA approvals 1:

• December 2014: Initially licensed for females ages 9-26 years and males ages 9-15 years 1
• December 2015: Extended to males through age 26 years 1
• October 2016: FDA approved the 2-dose schedule for persons ages 9-14 years 1
• October 2018: Extended approval to adults ages 27-45 years 2

Cervarix and original Gardasil were previously FDA-approved but are no longer distributed in the United States as of January 2017 1

Dosing Schedules for U.S. Vaccination

The dosing schedule depends on age at first dose, not the specific vaccine product 1, 2:

Two-Dose Schedule (Ages 9-14 Years at First Dose)

• Recommended for immunocompetent adolescents who initiate vaccination before their 15th birthday 1, 2
• Dose 1: Day 0 1, 2
• Dose 2: 6-12 months after first dose (minimum interval 12 weeks) 1, 2
• Longer intervals (closer to 12 months) produce stronger immune responses than shorter intervals 1, 2
• Younger adolescents (9-14 years) generate significantly higher antibody titers than older individuals receiving three doses, supporting the two-dose regimen 1, 2

Three-Dose Schedule (Ages ≥15 Years at First Dose)

• Required for all persons who initiate vaccination at age 15 years or older 1, 2
• Dose 1: Day 0 1, 2
• Dose 2: 1-2 months after first dose (minimum interval 4 weeks) 1, 2
• Dose 3: 6 months after first dose (minimum interval 12 weeks after dose 2) 1, 2

Special Populations Requiring Three Doses

• All immunocompromised persons require a three-dose schedule regardless of age at initiation 2
• This includes HIV-positive individuals, solid organ transplant recipients, and those on immunosuppressive medications 2

Clinical Recommendations for U.S. Practice

Routine Vaccination Age

Administer HPV vaccination routinely at age 11-12 years, though it can be started as early as age 9 years 1, 2:

• Vaccination before sexual debut provides maximum protection 1, 2
• Approximately 24% of adolescents report sexual intercourse by 9th grade and 58% by 12th grade 1, 2
• Nearly 60% of males acquire HPV infection within 2 years after sexual initiation 2

Catch-Up Vaccination

• Recommended for all persons through age 26 years who are not adequately vaccinated 2
• Shared clinical decision-making for adults ages 27-45 years 2

Important Clinical Considerations

• No prevaccination testing (HPV DNA, antibody, or Pap testing) is required before vaccination 2
• Prior HPV exposure, history of genital warts, abnormal Pap tests, or positive HPV tests are NOT contraindications to vaccination 2
• The vaccine protects against HPV types not yet acquired, even in sexually active individuals 1, 2
• Cervical cancer screening must continue regardless of vaccination status, as vaccines do not protect against all oncogenic HPV types 1, 2

Series Interruption

• If the vaccine series is interrupted, continue from where you left off—do NOT restart the series 2
• The critical determining factor is the age when the first dose was given, not when subsequent doses are administered 2
• There is no maximum time interval between doses 2

Common Pitfalls to Avoid

• Do not delay vaccination waiting for "optimal" timing—complete the series before sexual debut when possible 2
• Do not administer booster doses to individuals who completed their primary series—no booster is recommended regardless of which vaccine was used 5, 6
• Do not switch from 4vHPV or 2vHPV to 9vHPV after completing the original series—this is not recommended or cost-effective 6
• Do not skip cervical cancer screening in vaccinated women—screening remains essential 2, 5, 6
• Observe patients for 15 minutes post-vaccination due to syncope risk in adolescents 2

Comparative Immunogenicity Data (Historical Context)

While no longer clinically relevant for U.S. practice, historical studies showed 3, 4:

• Cervarix induced 3-9 fold higher peak neutralizing antibody titers to HPV 16/18 than original Gardasil 3
• Cervarix demonstrated sustained high antibody titers for at least 10 years 7
• Cervarix showed superior cross-protection against HPV types 31,33, and 45 compared to Gardasil 3, 4
• Both vaccines provided >90% efficacy in preventing CIN 2+ disease caused by HPV 16/18 in baseline-negative women 3

However, these comparisons are now academic since only Gardasil 9 is available in the United States.

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