What is the older version of Gardasil (Human Papillomavirus vaccine)?

The Original Gardasil HPV Vaccine

The original version of Gardasil was a quadrivalent vaccine that protected against HPV types 6,11,16, and 18, first licensed by the FDA in June 2006. 1, 2

Composition and Development

• The original Gardasil was manufactured by Merck & Co., Inc. as a quadrivalent vaccine
• It contained virus-like particles (VLPs) based on the L1 capsid protein of HPV types 6,11,16, and 18 1
• These VLPs contain no viral DNA and are not live/attenuated viruses, making them safe even for immunocompromised individuals 1
• The vaccine was designed to protect against:
  • HPV 16 and 18, which cause approximately 70% of cervical cancers
  • HPV 6 and 11, which cause approximately 90% of genital warts 2

Administration and Dosing

• The original recommended schedule was a 3-dose series 1:
  • First dose: at elected date
  • Second dose: 2 months after first dose
  • Third dose: 6 months after first dose
• Administered via intramuscular injection into the deltoid muscle or anterolateral thigh 1
• Initially approved for females aged 9-26 years 1, 3

Efficacy

• In clinical trials, the original Gardasil demonstrated 100% efficacy in preventing:
  • HPV16- or HPV18-related CIN2/3 and adenocarcinoma in situ (AIS) in women with no prior infection 1
  • HPV6/11/16/18-related external genital warts or vulvar/vaginal intraepithelial neoplasia 1
• Highest efficacy was observed when administered before exposure to HPV through sexual activity 4

Safety Profile

• Most common side effects included injection site reactions, headache (reported in up to half of patients), and fever 1
• Risk of syncope (fainting) led to recommendations that patients be observed for 15 minutes following administration 1
• No severe complications were directly linked to the vaccine 1
• Contraindicated in individuals with yeast allergies 1

Historical Context

• The original Gardasil was the first HPV vaccine approved for clinical use 3
• It was followed by Cervarix (bivalent vaccine protecting against HPV 16 and 18 only) developed by GlaxoSmithKline 1, 2
• Later, Gardasil 9 (nonavalent vaccine) was developed, which expanded coverage to nine HPV types 2

Clinical Implications

• The development of the original Gardasil represented a significant advancement in cervical cancer prevention
• Despite vaccination, cervical cancer screening remained necessary as the vaccine did not protect against all cancer-causing HPV types 1
• The original quadrivalent Gardasil has since been replaced by Gardasil 9, which provides broader protection against additional HPV types

The original Gardasil's introduction marked the beginning of HPV vaccination as a critical tool in preventing HPV-related cancers and diseases, significantly reducing morbidity and mortality associated with these conditions.