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Serum Institute seeks emergency use authorization for its Rbcg tuberculosis vaccine

The Serum Institute has applied to India’s drug controller general for an emergency use authorization for its recombinant BCG (rBCG) vaccine for the prevention of tuberculosis, official sources said on Sunday. The EUA application was submitted on March 22 by Prakash Kumar Singh, Director of Government and Regulatory Affairs at Serum Institute of India (SII).

The Indian Tuberculosis Immunization Program currently offers BCG vaccination at birth or as early as possible up to one year of age. SII already provides life-saving vaccines to the government under the Universal Immunization Program, including pneumococcal, IPV and rotavirus, Singh mentioned in his letter.

The Pune-based company is one of the companies supplying BCG vaccines to the government. “Our government is committed to eliminating tuberculosis. The vision of a TB-free India has been boosted by the Prime Minister’s call to end TB in our country by 2025, five years ahead of the Sustainable Development Goal to end TB,” Singh said in his letter.

“Under the leadership of our CEO Adar C Poonawalla, our company is committed to making available a safe, effective and high quality world-class TUBERVAC-rBCG vaccine for neonates, children, adolescents and adults. at an affordable price,” an official source quoted Singh as saying in the app.

Recombinant BCG vaccines are made using advanced technology that allows the insertion of foreign genes, or the overexpression of native genes, into the BCG vaccine, an official explained.

The number of tuberculosis cases in India increased by 19% in 2021 compared to the previous year, and the death rate from all forms of tuberculosis between 2019 and 2020 increased by 11%, according to the annual Report on Tuberculosis released by Union Health Minister Mansukh Mandaviya on Thursday.


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