Govt panel recommends market authorisation for Serum's cervical cancer vaccine

New Delhi, Jun 15: The subject expert committee (SEC) under the Drugs Controller General of India (DCGI) on Wednesday recommended granting of market authorisation to Serum Institute of India (SII) to manufacture indigenously-developed India's first Quadrivalent Human Papillomavirus vaccine (qHPV) against cervical cancer.

Prakash Kumar Singh, director (government and regulatory affairs) at SII had applied to Drugs Controller General of India (DCGI) on June 8 for market authorisation of qHPV after completing the phase 2/3 clinical trial with support of the Department of Biotechnology to ensure its early availability in the country.

In the application, Singh is learnt to have stated that qHPV vaccine CERVAVAC has demonstrated robust antibody response that is nearly 1,000 times higher than the baseline against all targeted HPV types and in all dose and age groups.

"The Subject Expert Committee (SEC) on COVID-19 of the CDSCO which deliberated on the application on Wednesday recommended granting market authorisation to Serum Institute to manufacture qHPV against cervical cancer," an official source told PTI.

The SII is also learnt to have made a presentation before the working group of HPV constituted separately by the NTAGI to review the data and usefulness of this vaccine last Wednesday.

Lakhs of women are diagnosed with cervical cancer and the death ratio is also very high. In India, cervical cancer ranks as the second most frequent cancer among women in the 15-44 age group.

Currently, our country is fully dependent only on foreign manufacturers for vaccine against cervical cancer and the citizens of our country are bound to buy these vaccines at a very high price.