The World Health Organization has granted prequalification to Cervavac, India's first indigenously developed gender-neutral quadrivalent vaccine against human papillomavirus, clearing the way for it to be purchased by United Nations agencies for immunisation programmes.
Serum Institute of India, which developed and manufactures the vaccine, announced the milestone this week. The recognition marks the 32nd WHO prequalification secured by the Pune-based manufacturer for its products and biologicals.
Inclusion on the WHO list of prequalified vaccines makes Cervavac eligible for procurement by UN bodies, a step that can open supply to countries working to expand protection against HPV, the virus responsible for nearly all cervical cancers.
Cervavac targets four HPV types — 6, 11, 16 and 18 — and is indicated for girls and boys aged nine through 26. In girls and women, it is indicated for the prevention of cervical, vulvar, vaginal and anal cancers caused by types 16 and 18, and genital warts caused by types 6 and 11. In boys and men, it covers anal cancer linked to types 16 and 18 and genital warts linked to types 6 and 11.
Those aged 9 to 14 receive the vaccine on a two-dose schedule, with 0.5 mL doses at zero and six months, while those aged 15 to 26 follow a three-dose schedule at zero, two and six months, given intramuscularly. The vaccine is supplied in single-dose 0.5 mL vials and two-dose 1.0 mL vials.
Adar Poonawalla, chief executive of Serum Institute of India, said the prequalification would strengthen the global response to HPV and open the door for countries to widen protection against HPV-related disease, describing it as a significant achievement for an indigenously developed vaccine.
Cervavac had earlier been approved for use in India by the Drugs Controller General of India.
Sources:
India's HPV vaccine Cervavac gets WHO's safety nod — The Indian Express
Serum Institute's Cervavac receives WHO prequalification — Hindustan Times
India's HPV Cancer Vaccine Cervavac Gets WHO Prequalification — ABP Live
Serum Institute of India, which developed and manufactures the vaccine, announced the milestone this week. The recognition marks the 32nd WHO prequalification secured by the Pune-based manufacturer for its products and biologicals.
Inclusion on the WHO list of prequalified vaccines makes Cervavac eligible for procurement by UN bodies, a step that can open supply to countries working to expand protection against HPV, the virus responsible for nearly all cervical cancers.
Cervavac targets four HPV types — 6, 11, 16 and 18 — and is indicated for girls and boys aged nine through 26. In girls and women, it is indicated for the prevention of cervical, vulvar, vaginal and anal cancers caused by types 16 and 18, and genital warts caused by types 6 and 11. In boys and men, it covers anal cancer linked to types 16 and 18 and genital warts linked to types 6 and 11.
Those aged 9 to 14 receive the vaccine on a two-dose schedule, with 0.5 mL doses at zero and six months, while those aged 15 to 26 follow a three-dose schedule at zero, two and six months, given intramuscularly. The vaccine is supplied in single-dose 0.5 mL vials and two-dose 1.0 mL vials.
Adar Poonawalla, chief executive of Serum Institute of India, said the prequalification would strengthen the global response to HPV and open the door for countries to widen protection against HPV-related disease, describing it as a significant achievement for an indigenously developed vaccine.
Cervavac had earlier been approved for use in India by the Drugs Controller General of India.
Sources:
India's HPV vaccine Cervavac gets WHO's safety nod — The Indian Express
Serum Institute's Cervavac receives WHO prequalification — Hindustan Times
India's HPV Cancer Vaccine Cervavac Gets WHO Prequalification — ABP Live
