Cervavac: India's first home-grown HPV vaccine wins WHO approval for global use
The decision allows United Nations agencies to purchase the vaccine, clearing the way for an affordable option to prevent cervical cancer in developing nations.
The World Health Organization has prequalified Cervavac, India’s first domestically developed vaccine against human papillomavirus (HPV). The decision clears the way for United Nations agencies to buy and distribute the vaccine globally, opening up a cheaper, mass-produced option for cervical cancer prevention in lower-income countries.
Developed and manufactured by the Pune-based Serum Institute of India, Cervavac is a gender-neutral vaccine designed to protect against four strains of HPV: types 6, 11, 16, and 18. Strains 16 and 18 are the primary drivers of cervical cancer, while types 6 and 11 cause most cases of genital warts.
Why the WHO prequalification matters
This decision marks the 32nd time a biological product from the Serum Institute of India has achieved WHO prequalification. More importantly, it allows procurement agencies like UNICEF and Gavi, the Vaccine Alliance, to buy the vaccine in bulk for international vaccination programmes.
Until now, many developing countries have struggled to access HPV vaccines due to tight global supply and high prices from multinational pharmaceutical companies. An affordable, India-made alternative could dramatically change the economics of immunisation campaigns in sub-Saharan Africa and South Asia, where cervical cancer remains one of the leading causes of cancer deaths among women.
Who can take Cervavac and how is it given?
The vaccine is approved for both males and females aged between 9 and 26.
The dosing schedule depends on the patient's age:
- Ages 9 to 14: Two doses are required.
- Ages 15 to 26: Three doses are required.
It is administered as an intramuscular injection. To suit different healthcare settings, the Serum Institute packages the vaccine in two formats: 0.5 ml single-dose vials and 1.0 ml two-dose vials.
The vaccine is indicated to prevent cervical, vulvar, vaginal, and anal cancers in girls and women, as well as anal cancer and genital warts in boys and young men.
Development and local approvals
Cervavac was first approved for use in India by the Drugs Controller General of India. Its creation was the result of a public-private partnership. The Serum Institute worked alongside the Indian government's Department of Biotechnology and the Biotechnology Industry Research Assistance Council (BIRAC). The partnership also involved international bodies, including the Bill & Melinda Gates Foundation and the WHO’s own International Agency for Research on Cancer.
Adar Poonawalla, chief executive of the Serum Institute, said the WHO prequalification "reflects the effectiveness of the vaccine and creates the opportunity for countries to prevent HPV-related risks." He added that the company looks forward to "contributing to immunisation coverage, advancing global healthcare."
Key numbers
| What | Figure | Source |
|---|---|---|
| Prequalification milestone | 32nd WHO prequalification for Serum Institute of India | Serum Institute of India |
| Target age range | 9 to 26 years old | Serum Institute of India |
| Doses for ages 9 to 14 | Two doses | Serum Institute of India |
| Doses for ages 15 to 26 | Three doses | Serum Institute of India |
In this story
| Name | Role in the story |
|---|---|
| Serum Institute of India | The Indian biotechnology and biopharmaceuticals company that manufactures Cervavac. |
| World Health Organization | The international health body that granted the vaccine prequalification. |
| Cervavac | The newly WHO-prequalified HPV vaccine manufactured in India. |
