India's First Indigenous HPV Vaccine Gets WHO Prequalification
The vaccine -- which was developed by the Serum Institute of India (SII) -- had earlier received approval from India's Drugs Controller General of India (DCGI) for domestic use.
Cervavac is a quadrivalent, gender-neutral vaccine that can be administered to both girls and boys between the ages of nine and 26 years.
It targets four HPV strains -- types 6, 11, 16 and 18. While HPV types 6 and 11 are commonly associated with genital warts, types 16 and 18 are considered high-risk strains linked to several cancers.
In women, the vaccine helps protect against cervical, vulvar, vaginal and anal cancers associated with HPV infection.
On the other hand, in men, it provides protection against HPV-related anal cancer.
According to SII, children aged 9-14 years should receive two doses administered six months apart, while individuals aged 15-26 years require a three-dose schedule within a year.
Commenting on the development, Serum Institute Chief Executive Officer Adar Poonawalla said the WHO prequalification marks an important step in strengthening the global fight against HPV-related diseases and broadening access to preventive vaccination.
The vaccine contains proteins designed to generate an immune response against the four targeted HPV strains and is manufactured using the Hansenula polymorpha expression system.
WHO prequalification is a key benchmark for vaccine quality, safety and efficacy and allows international agencies and global immunisation programmes to procure the product.
Cervavac was developed by SII in partnership with the Department of Biotechnology, Biotechnology Industry Research Assistance Council (BIRAC), WHO's International Agency for Research on Cancer (IARC) and the Gates Foundation.
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