About recombinant human papillomavirus vaccine
Recombinant human papillomavirus (HPV) vaccine manufacturers include Merck (Gardasil, Gardasil 9), GSK (Cervarix), Xiamen Innovax (Cecolin, Cecolin 9), Walvax (Walrinvax) and Serum Institute of India (Cervavac). HPV vaccines contain virus-like particles made from the HPV L1 protein, produced in yeast, insect cells or bacteria. They prevent cervical, anal and other HPV-related cancers and genital warts. Several are WHO prequalified for use in national immunisation programmes. Pharmaceutical companies can source HPV vaccines through supply, regional licensing or technology transfer.
Recombinant human papillomavirus vaccine key facts
|
Property |
Recombinant HPV vaccine |
|---|---|
|
Vaccine type |
Recombinant L1 virus-like particle (VLP) vaccine |
|
ATC codes |
J07BM01 (quadrivalent); J07BM02 (bivalent); J07BM03 (9-valent) |
|
Bivalent vaccines (HPV 16, 18) |
Cervarix (GSK, insect cells); Cecolin (Innovax, E. coli); Walrinvax (Walvax, Pichia pastoris) |
|
Quadrivalent vaccines (HPV 6, 11, 16, 18) |
Gardasil (Merck, yeast); Cervavac (Serum Institute of India) |
|
9-valent vaccines (adds 31, 33, 45, 52, 58) |
Gardasil 9 (Merck); Cecolin 9 (Innovax, China) |
|
Dosage form |
Suspension for intramuscular injection, 0.5 ml dose |
|
Indications |
Prevention of cervical, vulvar, vaginal, anal and some head and neck cancers and precancers; genital warts (quadrivalent and 9-valent) |
|
First approval |
Gardasil, US FDA, June 2006 |
|
New entrants |
Cecolin (China, Dec 2019; WHO PQ Oct 2021); Walrinvax (China, 2022); Cervavac (India, 2022); Cecolin 9 (China, 2025) |
|
WHO schedule |
One or two doses for girls and women aged 9–20 |
|
Generic / biosimilar status |
Not applicable; each vaccine licensed separately |
Recombinant human papillomavirus vaccine manufacturers and licensing history
Merck's Gardasil was the first HPV vaccine, approved in the US in June 2006, followed by GSK's Cervarix in 2007. Merck's Gardasil 9, covering nine HPV types, is now the main vaccine in high-income countries. Cervarix was withdrawn from the US market in 2016 but remains available elsewhere.
New producers have expanded supply. Innovax's Cecolin, made in E. coli, was licensed in China in December 2019 and WHO prequalified in October 2021. Walvax's Walrinvax, made in yeast, was licensed in China in 2022. Serum Institute of India launched the quadrivalent Cervavac in 2022. In 2025, China approved Innovax's Cecolin 9, its first domestic 9-valent vaccine.
HPV vaccines are complex biologics. Buyers should confirm WHO prequalification or national licensing, GMP status, supply capacity and cold-chain requirements before choosing a supplier.
Recombinant human papillomavirus vaccine dosage forms and dossier types
HPV vaccines are supplied as suspensions for intramuscular injection, in prefilled syringes or vials.
|
Form |
Valency |
Typical dossier |
Notes |
|---|---|---|---|
|
9-valent HPV vaccine |
HPV 6, 11, 16, 18, 31, 33, 45, 52, 58 |
US BLA; EU MAA; national licence |
Gardasil 9, Cecolin 9 |
|
Quadrivalent HPV vaccine |
HPV 6, 11, 16, 18 |
US BLA; EU MAA; WHO PQ; national licence |
Gardasil, Cervavac |
|
Bivalent HPV vaccine |
HPV 16, 18 |
EU MAA; WHO PQ; national licence |
Cervarix, Cecolin, Walrinvax |
|
Target market |
Dossier format |
Key requirement |
|---|---|---|
|
WHO / UNICEF / Gavi tenders |
WHO prequalification |
Single-dose schedule data increasingly relevant |
|
United States, European Union |
BLA / MAA |
Gardasil 9 is the main product |
|
China, India |
National vaccine licence |
Domestic producers growing |
|
Other markets |
National licence |
Reference to WHO PQ or stringent approval |
Recombinant human papillomavirus vaccine regulatory and patent status
Each HPV vaccine is licensed separately, as there are no generic vaccines. Gardasil was first approved in June 2006 and Gardasil 9 in 2014. Cecolin, Walrinvax and Gardasil products are WHO prequalified, and the WHO now recommends one or two doses for girls and women aged 9–20. In October 2024, the WHO added Cecolin to the vaccines that can be used on a single-dose schedule.
Recombinant human papillomavirus vaccine mechanism of action and therapeutic use
HPV vaccines contain virus-like particles that look like the outer shell of HPV but contain no viral DNA, so they cannot cause infection. They trigger strong antibody responses that prevent infection with the HPV types in the vaccine. HPV vaccines are used to prevent cervical and other HPV-related cancers and, for some vaccines, genital warts. They work best when given before any exposure to HPV.
Recombinant human papillomavirus vaccine licensing and sourcing
HPV vaccine suppliers and licensing partners typically offer finished vaccine supply, regional licensing or technology transfer. Buyers usually compare WHO prequalification, valency, GMP status, supply capacity and price. Current offers and supplier contacts are listed among the recombinant human papillomavirus vaccine manufacturers on Pipelinepharma.
Frequently asked questions about recombinant human papillomavirus vaccine
Who are the main HPV vaccine manufacturers? Merck (Gardasil, Gardasil 9) and GSK (Cervarix) are the original producers. Xiamen Innovax, Walvax and Serum Institute of India now also make HPV vaccines.
Which HPV vaccines are WHO prequalified? WHO-prequalified HPV vaccines include Merck's Gardasil and Gardasil 9, GSK's Cervarix, Innovax's Cecolin and Walvax's Walrinvax.
What is the difference between bivalent, quadrivalent and 9-valent HPV vaccines? Bivalent vaccines cover HPV 16 and 18. Quadrivalent vaccines add 6 and 11, which cause genital warts. 9-valent vaccines add five more cancer-causing types: 31, 33, 45, 52 and 58.
How many doses of HPV vaccine are needed? The WHO recommends one or two doses for girls and women aged 9–20, with more doses for older people or those with weakened immunity.
Is there a generic HPV vaccine? No. Each HPV vaccine is licensed separately on its own data.
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