Evaluation of new HPV vaccine by IARC and partners supports recommendation to grant marketing authorization for the vaccine

Scientists from the International Agency for Research on Cancer (IARC) were part of a unique collaboration between the Department of Biotechnology of the Government of India, the United States National Institutes of Health, and the Bill & Melinda Gates Foundation to support the evaluation of a quadrivalent human papillomavirus (HPV) vaccine manufactured by the Serum Institute of India (SII) in females and males aged 9–26 years.

This unique model of public–private partnership resulted in a successful and timely completion of phase II and phase III vaccine efficacy trials, despite the threat posed by the COVID-19 pandemic. On 15 June 2022, after reviewing the study outcomes, the Subject Expert Committee (SEC) on Vaccines to advise the Drugs Controller General of India recommended granting marketing authorization for the new vaccine for females and males aged 9–26 years.

Vaccines produced by SII have been used in international vaccination programmes, including COVAX, the vaccines pillar of the Access to COVID-19 Tools (ACT) Accelerator, led by the World Health Organization (WHO), UNICEF, and the Pan American Health Organization (PAHO). An approval by the Drugs Controller General will permit the Government of India to procure enough HPV vaccines produced by SII at a special price to vaccinate nearly 50 million girls aged 9–14 years in India who are waiting to receive the vaccine. This will be a huge step to accelerate cervical cancer elimination in India and globally.