Serum Institute of India's HPV Vaccine Cervavac^® receives WHO Prequalification

This indicates a step towards broader and global prevention of Human Papillomavirus associated diseases for both boys and girls.

Pune, India, October 05, 2026: CERVAVAC^®, India’s first indigenously developed gender-neutral Quadrivalent Human Papillomavirus vaccine (qHPV) developed by Serum Institute of India receives prequalification by the World Health Organization (WHO).

This regulatory milestone marks the 32nd WHO prequalification for products/biologicals received by Serum Institute of India. Inclusion on the WHO List of Prequalified Vaccines allows CERVAVAC^® to be procured by United Nations agencies.

This recombinant quadrivalent HPV vaccine targets HPV types 6, 11, 16 and 18. It is indicated for girls and boys aged 9 through 26 years.

Mr. Adar Poonawalla, Chief Executive Officer, Serum Institute of India, said: "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."

Previously approved for its use in India by the Drugs Controller General of India (DCGI), CERVAVAC^® is administered for the prevention of diseases caused by the four HPV types. This includes the prevention of anal cancer in boys and young men, and cervical, vulvar, vaginal, and anal cancers in girls and young women. It is also indicated in preventing genital warts, as applicable to the indicated population.

About CERVAVAC^®

Developed in collaboration with the Department of Biotechnology (DBT) and the Biotechnology Industry Research Assistance Council (BIRAC), along with the WHO-IARC (International Agency for Research on Cancer) and the Gates Foundation, CERVAVAC^® is a recombinant quadrivalent HPV vaccine targeting HPV types 6, 11, 16 and 18.

CERVAVAC^® is indicated in girls and women 9 through 26 years of age for the prevention of cervical, vulvar, vaginal and anal cancer caused by HPV types 16 and 18, and genital warts caused by HPV types 6 and 11. CERVAVAC^® is indicated in boys and men 9 through 26 years of age for the prevention of anal cancer caused by HPV types 16 and 18, and genital warts caused by HPV types 6 and 11.

Individuals 9 to 14 years of age receive CERVAVAC^® according to a 2-dose schedule (0.5 mL at 0, 6 months), while individuals 15 to 26 years of age receive a 3-dose (0.5 mL at 0, 2, 6 months) schedule. The vaccine is administered intramuscularly. CERVAVAC^® is available in 1-dose vials of 0.5 ml and 2-dose vials of 1.0 ml presentations.

About Serum Institute of India

Serum Institute of India Pvt. Ltd., part of Cyrus Poonawalla Group is a global leader in vaccine manufacturing, dedicated to providing affordable vaccines worldwide. Present across 170+ countries, including the US, UK, and Europe, SII holds the distinction of being the world’s largest vaccine manufacturer. SIIPL’s multifunctional production and one-of-the-largest facilities in Hadapsar & Manjari, Pune, with an annual capacity of 4 billion doses, has saved over 30 million lives over the years.

Founded in 1966, SIIPL’s primary mission is to produce life-saving immunobiological drugs, with a particular emphasis on affordability and accessibility. Guided by a strong commitment to improving global health, the company has played a pivotal role in reducing the prices of essential vaccines, such as Diphtheria, Tetanus, Pertussis, HIB, BCG, r-Hepatitis B, Measles, Mumps, and Rubella. Notably, they are the manufacturers of ‘Pneumosil,’ the world’s most affordable PCV, ‘Cervavac’ the first indigenous qHPV vaccine in India, and R21/Matrix-M™, the second Malaria vaccine to be authorized for use in children in malaria-endemic regions, ‘MenFive’, the first in the world Pentavalent (ACYWX) Meningococcal Polysaccharide Conjugate Vaccine, approved and WHO-prequalified for use in the pediatric and adult population. Moreover, SIIPL has been at the forefront of the global fight against COVID-19, delivering over 2 billion doses of the COVID-19 vaccine worldwide.

To further expand its global presence and ensure widespread vaccine availability, SII has established Serum Life Sciences Ltd, a subsidiary in the UK and Serum Inc., a subsidiary in the US. Through relentless pursuit of innovation, SII continues to champion the cause of affordable vaccines, making a positive impact on the lives of millions worldwide. www.seruminstitute.com