India's HPV vaccine Cervavac gets WHO's safety nod

Cervavac, India's first indigenously developed gender-neutral quadrivalent Human Papillomavirus vaccine (qHPV) developed by Serum Institute of India has got the prequalification status 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 (UN) agencies. The vaccine targets HPV types 6, 11, 16 and 18. It is indicated for girls and boys aged nine through 26 years.

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.

Cervavac is indicated in girls and women between 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. Cervavac 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.

Those between 9 and 14 years of age receive Cervavac according to a two-dose schedule (0.5 mL at 0, 6 months), while individuals 15 to 26 years of age receive a three -dose (0.5 mL at 0, 2, 6 months) 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 presentations.