WHO prequalifies Serum Institute’s quadrivalent HPV vaccine CERVAVAC

Why in the News

For the first time, an Indian made quadrivalent human papillomavirus (HPV) vaccine has entered the World Health Organization (WHO) list of prequalified vaccines, which until now held only HPV vaccines made outside India. The Serum Institute of India’s CERVAVAC has received WHO prequalification, opening United Nations procurement channels to it.

What does WHO prequalification mean?

1. What it is: WHO prequalification certifies that a vaccine meets WHO standards for quality, safety and efficacy. It works like a global seal of approval that buyers for many countries can trust.
2. How it is earned: WHO evaluates the data, tests samples and inspects manufacturing facilities. A vaccine that passes is placed on the WHO List of Prequalified Vaccines.
3. What it unlocks: Listing makes a vaccine eligible for purchase by United Nations agencies for national immunisation programmes, mainly in low and middle income countries.
4. What it is not: Prequalification is “not a marketing authorisation or regulatory approval”. CERVAVAC was already licensed in India.
5. The takeaway: A cervical cancer vaccine made in India can now reach immunisation programmes abroad, not only India’s own.

What is CERVAVAC and why do its four HPV types matter?

1. HPV: HPV is an extremely common sexually transmitted infection. Most infections clear naturally, but WHO estimates persistent infection with high risk types causes more than 95% of cervical cancers.
2. Wider disease burden: HPV also causes anal, vulval, vaginal and other cancers and genital warts, including in men.
3. High risk types: HPV 16 and 18 are high risk types behind a large share of cervical cancers.
4. Wart causing types: HPV 6 and 11 cause most anogenital warts, so a quadrivalent (four type) vaccine protects against both cancers and warts.
5. Gender neutral licence: CERVAVAC is India’s first indigenously developed gender neutral quadrivalent HPV vaccine, licensed for girls and boys aged 9 to 26.

What does prequalification change for India’s HPV programme?

1. National programme: India’s national HPV vaccination programme, launched in February 2026, offers a free single dose to 14 year old girls.
2. Coverage so far: More than 80 lakh doses had been given by September, against a target of about 1.2 crore girls.
3. Vaccines in use: The programme uses Merck’s Gardasil-4, a quadrivalent vaccine against the same four types. CERVAVAC, Gardasil-9 and Cervarix are sold on the private market.
4. No automatic switch: Prequalification does not mean CERVAVAC will replace Gardasil-4. Programme choice weighs regulatory status, evidence, price, supply capacity and logistics.
5. Domestic second source: A WHO prequalified HPV vaccine from an Indian maker could strengthen competition and supply security in future procurement.

Where does CERVAVAC sit among Indian vaccines and the global HPV effort?

1. Global HPV list: WHO’s HPV product list carried bivalent Cecolin, Cervarix and Walrinvax, quadrivalent Gardasil and nonavalent Gardasil-9, all made outside India.
2. Serum Institute’s portfolio: Serum Institute already holds WHO prequalification for vaccines including BCG, measles, polio, rabies, rotavirus, malaria and pneumococcal disease.
3. Other Indian makers: Bharat Biotech, Biological E, Zydus Lifesciences, GreenSignal Bio Pharma, Haffkine and Panacea Biotec also hold prequalified vaccines. Eg. Bharat Biotech’s Typbar-TCV, the first prequalified typhoid conjugate vaccine.
4. WHO target: WHO aims to have 90% of girls fully vaccinated against HPV by age 15, alongside screening and treatment targets for women.
5. Coverage gap: By the end of 2025, global first dose coverage among girls was only about 33%.

Challenges

1. Parental consent: School drives stall on parental consent and trust. Eg. Delhi government schools in 2026.
2. Low screening: Only 1.7% of Indian women have ever been screened for cervical cancer (National Family Health Survey, NFHS-5).
3. Boys left out: The national programme covers only girls, though CERVAVAC is licensed for boys.

Way Forward

1. Second supplier: Assess CERVAVAC as a second supplier for the national programme to secure price and supply.
2. Screening at primary centres: Pair vaccination with cervical cancer screening at Ayushman Arogya Mandirs (Health and Wellness Centres).
3. Community outreach: Use schools and Accredited Social Health Activists (ASHAs) to win parents’ consent.

Conclusion

India now makes an HPV vaccine that meets the global benchmark, yet its own programme runs on an imported product and global coverage remains far below target. Whether CERVAVAC enters national and United Nations procurement at a competitive price is the next marker.

Key numbers

1. Prequalification effective date: September 25, 2026 (WHO).
2. Cervical cancer worldwide (2020): about 6,04,000 new cases and 3,42,000 deaths.
3. Countries with HPV vaccination (end 2025): 165.
4. WHO priority group: girls aged 9 to 14, before exposure to the virus, on a one or two dose schedule.

Matching Previous Year Question

“[2022] In the context of vaccines manufactured to prevent COVID-19 pandemic, consider the following statements : 1. The Serum Institute of India produced COVID-19 vaccine named Covishield using mRNA platform. 2. Sputnik V vaccine is manufactured using vector based platform. 3. COVAXIN is an inactivated pathogen based vaccine. Which of the statements given above are correct? (a) 1 and 2 only (b) 2 and 3 only (c) 1 and 3 only (d) 1, 2 and 3 ANSWER: (b)”