Serum Institute’s CERVAVAC HPV vaccine receives WHO prequalification, making it eligible for procurement by UN agencies and supporting global HPV prevention.
Written By: Charvi Kalal, PharmD
Reviewed By: Pharmacally Editorial Team
Serum Institute of India (SII) announced on October 5, 2026, that CERVAVAC, its recombinant quadrivalent human papillomavirus (qHPV) vaccine, has received World Health Organization (WHO) prequalification. The vaccine is described by SII as India’s first indigenously developed gender-neutral qHPV vaccine and is intended to support broader prevention of HPV-associated diseases in both girls and boys.
WHO’s official listing records the prequalification as effective September 25, 2026. The milestone makes CERVAVAC eligible for procurement by United Nations agencies, creating a pathway for its potential use in national immunisation programmes beyond India.
What WHO Prequalification Means
According to SII, CERVAVAC represents the company’s 32nd WHO prequalification for its vaccines and biological products. Inclusion on the WHO List of Prequalified Vaccines indicates that the product has met WHO’s applicable standards for quality, safety and efficacy and can be considered for procurement by UN agencies.
However, WHO prequalification does not automatically mean that CERVAVAC will be introduced into a particular country’s national immunisation programme. Country-level regulatory decisions, procurement processes and immunisation policies remain separate steps.
About CERVAVAC
CERVAVAC is a recombinant quadrivalent HPV vaccine targeting HPV types 6, 11, 16 and 18. It is indicated for girls and boys aged 9 through 26 years.
The vaccine was developed by SII with support and collaboration involving India’s Department of Biotechnology (DBT), Biotechnology Industry Research Assistance Council (BIRAC), the WHO International Agency for Research on Cancer (IARC) and the Bill & Melinda Gates Foundation. CERVAVAC previously received marketing authorization in India and was launched nationally on January 24, 2023.
Indications
In girls and women aged 9 through 26 years, CERVAVAC is indicated for the prevention of cervical, vulvar, vaginal and anal cancers associated with HPV types 16 and 18, as well as genital warts caused by HPV types 6 and 11.
In boys and men aged 9 through 26 years, the vaccine is indicated for prevention of anal cancer associated with HPV types 16 and 18 and genital warts caused by HPV types 6 and 11.
Dosing Schedule and Presentations
For individuals aged 9 to 14 years, CERVAVAC is administered as a two-dose schedule, with 0.5 mL given at 0 and 6 months. Individuals aged 15 to 26 years receive a three-dose schedule at 0, 2 and 6 months.
The vaccine is administered intramuscularly and is available in 0.5 mL single-dose vials and 1.0 mL two-dose vials. WHO’s prequalification records describe CERVAVAC as a ready-to-use liquid vaccine with a 36-month shelf life. It should be stored at 2–8°C and contains no preservative.
For the multidose presentation, WHO specifies that an opened vial should be discarded six hours after opening or at the end of the immunisation session, whichever comes first.
Statement from Serum Institute of India
Adar Poonawalla, Chief Executive Officer of Serum Institute of India, described the WHO prequalification as an important step in strengthening the global response to HPV. He said the milestone reflects the vaccine’s effectiveness and could give countries an additional opportunity to prevent HPV-related disease.
About Serum Institute of India
Founded in 1966, Serum Institute of India is a major vaccine manufacturer supplying vaccines to more than 170 countries, with reported annual capacity of 4 billion doses. Its portfolio includes Pneumosil, R21/Matrix-M and MenFive, alongside COVID-19 vaccines.
These figures represent company-reported information.
Path Forward
Further deployment will depend on procurement decisions, country-level regulatory requirements and national immunisation policies. The WHO listing therefore represents an important regulatory and procurement milestone, rather than confirmation of immediate global programme introduction.
For India, where CERVAVAC was launched in 2023, the WHO prequalification marks a further step in the international recognition and potential global availability of an indigenously developed HPV vaccine.
Reference
Serum Institute’s Indigenous HPV Vaccine CERVAVAC Gets WHO Prequalification, Opens Way for UN Procurement, Medical Dialogues, 5 October 2026
Pune: Serum Institute’s Cervavac receives WHO prequalification, ANI, 5 October 2026
CERVAVAC (1-dose vial), WHO Prequalification of Medical Products, World Health Organization, accessed 5 October 2026
CERVAVAC (2-dose vial), WHO Prequalification of Medical Products, World Health Organization, accessed 5 October 2026
About the Writer
Charvi Kalal (LinkedIn) is a Pharm.D intern and aspiring medical writer with hands-on experience in medical writing, clinical research, pharmacovigilance, and clinical pharmacy. She has experience in medical content writing through CliMed, along with exposure to ADR monitoring, prescription analysis, patient counselling, literature review, and research documentation. Her research focuses on ADR monitoring and reporting in breast cancer patients receiving targeted therapy. With certifications in GCP, biomedical research, scientific writing, and clinical research, she is passionate about transforming scientific evidence into accurate, engaging, and accessible healthcare content.