Pune (Maharashtra) [India], October 5 (ANI): India’s first indigenously developed Human Papillomavirus (HPV) vaccine, Cervavac, manufactured by the Serum Institute of India (SII), received prequalification from the World Health Organisation (WHO).
The regulatory milestone marks the 32nd WHO prequalification for biological products received by the Serum Institute of India. Inclusion on the WHO list of prequalified vaccines enables Cervavac to be procured by United Nations agencies for global distribution.
The recombinant quadrivalent HPV vaccine targets HPV strains 6, 11, 16, and 18, and is indicated for use in girls and boys aged 9 through 26 years.
Chief Executive Officer of the Serum Institute of India, Adar Poonawalla, hailed the development, emphasising that the milestone reflects the effectiveness of the vaccine and creates the opportunity for countries to prevent HPV-related risks, while expressing enthusiasm to contribute to immunisation coverage and enhance global healthcare.
“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 Poonawala.
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.
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.
This vaccine 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 for preventing genital warts.
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. It 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, while individuals 15 to 26 years of age receive a 3-dose 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. (ANI)
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