Serum Institute of India’s (SII) Cervavac—a quadrivalent human papillomavirus (qHPV) vaccine— is likely to be the first indigenous qHPV vaccine to be approved in India, according to GlobalData.

Neha Myneni, Pharma Analyst, GlobalData, comments, “We are finally in sight of having an India-developed HPV vaccine! This will be a huge relief to the poorer members of our community who cannot afford the high price mark that comes with those offered by foreign manufacturers (approximately INR6,000–7,000 for a complete regimen). There are currently only two prophylactic HPV vaccines approved in India, and they are both manufactured abroad: Merck’s Gardasil (qHPV vaccine) and GSK’s Cervarix (bivalent HPV vaccine). Cervavac will be a welcome option.”

GlobalData notes that the National Technical Advisory Group on Immunisation recommended including HPV vaccination under the Universal Immunisation Programme (UIP) to the Union health ministry. Although HPV vaccines were approved for inclusion in India’s UIP in 2017, they were not adopted nationally, mainly due to pricing concerns.

Myneni continues, “Lack of inclusion in UIP means the benefits of these vaccines are not reaching the people in utmost need. This issue will likely be addressed once a domestic player like SII enters the HPV vaccination space. Cervavac is expected to be launched in November 2022.” 

One challenge for SII is the lack of awareness among Indian women. Although cervical cancer is the second most frequent among Indian women aged between 15 and 44 years, awareness of this disease is minimal.