Serum Institute's Cervavac Receives WHO Prequalification
India's first indigenous HPV vaccine, Cervavac by Serum Institute, receives WHO prequalification for global distribution.
In a major breakthrough for India's biotechnology sector, the Serum Institute of India (SII) has announced that its indigenously developed Human Papillomavirus (HPV) vaccine, Cervavac, has officially received prequalification from the World Health Organisation (WHO).
This regulatory milestone is significant as it marks the 32nd WHO prequalification for biological products achieved by the Serum Institute. Being included on the WHO's prequalified list means that United Nations agencies can now procure Cervavac for large-scale global distribution, potentially transforming cancer prevention efforts worldwide.
A Shield Against HPV-Related Cancers
Cervavac is a recombinant quadrivalent vaccine designed to target four specific strains of the Human Papillomavirus: types 6, 11, 16, and 18. The vaccine is engineered to provide protection against a range of serious health conditions, including:
- In girls and women: Prevention of cervical, vulvar, vaginal, and anal cancers, as well as genital warts.
- In boys and men: Prevention of anal cancer and genital warts.
The vaccine is indicated for use in both girls and boys within the age group of 9 to 26 years.
Collaborative Development and Global Impact
The journey of Cervavac from a concept to a WHO-prequalified product involved extensive collaboration. The vaccine was developed alongside the Department of Biotechnology (DBT) and the Biotechnology Industry Research Assistance Council (BIRAC), with support from the WHO-IARC (International Agency for Research on Cancer) and the Gates Foundation.
Adar Poonawalla, the Chief Executive Officer of the Serum Institute of India, expressed immense pride in this achievement. He noted that the prequalification is a vital step in strengthening the global response to HPV and provides a massive opportunity for nations to mitigate HPV-related health risks.
“WHO prequalification of Cervavac is an important step in strengthening the global response to HPV. This milestone reflects the effectiveness of the vaccine and creates the opportunity for countries to prevent HPV-related risks. We are pleased to see this indigenously developed vaccine reach this achievement, and look forward to contributing to immunisation coverage, advancing global healthcare,” said Adar Poonawalla.
Dosage and Administration Details
For those receiving the vaccine, the administration follows specific protocols based on age to ensure maximum efficacy:
- Ages 9 to 14 years: A 2-dose schedule is required.
- Ages 15 to 26 years: A 3-dose schedule is required.
The vaccine is administered via intramuscular injection and is available in two formats: 1-dose vials of 0.5 mL and 2-dose vials of 1.0 mL. Previously approved for domestic use by the Drugs Controller General of India (DCGI), Cervavac is now poised to become a key player in the global fight against preventable cancers.