Cervavac, India's first indigenously developed gender-neutral Quadrivalent Human Papillomavirus (qHPV) vaccine, has received prequalification by the World Health Organisation (WHO). Manufactured by the Serum Institute of India (SII), this recombinant quadrivalent HPV vaccine targets HPV types 6, 11, 16 and 18. This regulatory milestone allows Cervavac to be procured by United Nations agencies.

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

What is Cervavac?

Cervavac is indicated for girls and boys aged 9 through 26 years. Previously approved for its use in India by the Drugs Controller General of India (DCGI), it is administered for the prevention of diseases caused by the four HPV types.

It helps prevent the following diseases caused by HPV types:

In girls and women:

  • Cervical, vulvar, vaginal, and anal cancer caused by HPV types 16 and 18
  • Genital warts (condyloma acuminata) caused by HPV types 6 and 11

In boys and men:

  • Anal cancer caused by HPV types 16 and 18
  • Genital warts (condyloma acuminata) caused by HPV types 6 and 11

Dosage schedule

The vaccine is administered according to age groups:

  • Ages 9 to 14: A 2-dose schedule given at 0 and 6 months
  • Ages 15 to 26: A 3-dose schedule given at 0, 2, and 6 months

HPV types 16 and 18 are high-risk strains responsible for the vast majority of cervical cancers, while types 6 and 11 are low-risk strains linked to genital warts. By being gender-neutral, Cervavac prevents a broad spectrum of diseases across populations.

This milestone marks the 32nd WHO prequalification for biological products and vaccines received by the Serum Institute of India.



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