Serum Institute of India’s HPV vaccine CERVAVAC® receives WHO prequalification

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.

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.

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.