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NTAGI to review trial data on Serum Institute’s qHPV vaccine against cervical cancer

A separate HPV working group of the National Technical Advisory Group on Immunisation (NTAGI) had examined on 8th June the clinical trial data and usefulness of the vaccine for inclusion in the national immunisation programme

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The government advisory panel NTAGI is likely to review on 28th June trial data on India’s first quadrivalent human papillomavirus vaccine against cervical cancer, developed by the Serum Institute, official sources said recently.

A separate HPV working group of the National Technical Advisory Group on Immunisation (NTAGI) had examined on 8th June the clinical trial data and usefulness of the vaccine for inclusion in the national immunisation programme, they said.

In the meantime, Prakash Kumar Singh, Director, Government and Regulatory Affairs, Serum Institute of India (SII), applied to the Drugs Controller General of India (DCGI) seeking market authorisation for the vaccine after the phase-II/III clinical trial was completed with the support of the Department of Biotechnology (DBT) to ensure its early availability in the country.

According to official sources, based on this application, the Subject Expert Committee (SEC) of the Central Drugs Standard Control Organization (CDSCO) had recommended on 15th June granting market authorisation to the jab.

The approval of the DCGI is still awaited.

According to the application submitted by Singh, the vaccine, Cervavac, has demonstrated robust antibody response that is nearly 1,000 times higher than the baseline against all targetted HPV types and in all doses and age groups.

The application mentioned that lakhs of women are diagnosed every year with cervical and a few other types of cancer and the death ratio is very high.

Edits by EP News Bureau

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