Gardasil's Market Introduction Timeline
Gardasil was first approved by the U.S. Food and Drug Administration (FDA) and introduced to the market on June 8,2006, as the first quadrivalent human papillomavirus (HPV) vaccine. 1, 2
Details of Gardasil's Initial Approval
The initial FDA approval in 2006 authorized Gardasil for:
- Use in females aged 9-26 years
- Prevention of HPV types 6,11,16, and 18-related conditions
- Protection against cervical cancer, cervical cancer precursors, vaginal and vulvar cancer precursors, and anogenital warts 3, 1
Vaccine Composition and Development
Gardasil is a quadrivalent vaccine that consists of:
- Recombinant viral-like particles (VLPs) of HPV types 6,11,16, and 18
- An aluminum-containing adjuvant
- Manufactured by Merck & Co., Inc. 1, 2
Timeline of Expanded Approvals
After its initial introduction in 2006, Gardasil's approval was expanded:
- September 2006: Approved in the European Union 4
- By 2011: Approved in 121 countries with over 74 million doses distributed globally 4
- October 16,2009: FDA expanded licensure to include males aged 9-26 years for prevention of genital warts caused by HPV types 6 and 11 5
Initial Vaccination Recommendations
When first introduced, the Advisory Committee on Immunization Practices (ACIP) recommended:
- Primary target population: females aged 11-12 years
- Vaccination could be given to girls as young as 9 years of age
- Catch-up vaccination for females aged 13-26 years 3, 1
Administration Protocol
The original administration protocol, which remains largely unchanged:
- Three 0.5 mL doses given intramuscularly
- First dose at elected date
- Second dose two months after first dose
- Third dose six months after first dose 3, 1, 6
Market Context
Gardasil was the first HPV vaccine available, with GlaxoSmithKline's bivalent vaccine (Cervarix) following later:
- Cervarix (bivalent HPV 16,18 vaccine) was in Phase III trials when Gardasil was first approved
- Cervarix was expected to be released approximately one year after Gardasil 1
Gardasil represented a significant advancement in preventive medicine as the first vaccine specifically designed to prevent certain types of cancer, particularly cervical cancer, which is the second most common cancer among women worldwide 1.