Serum Institute Seeks Emergency Use Authorisation For Its rBCG Tuberculosis Vaccine

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The Serum Institute has applied to the Drugs Controller General of India seeking emergency use authorisation 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 the Serum Institute of India (SII).

India's TB immunisation programme currently offers BCG vaccination at birth or as early as possible till one year of age.

SII already supplies life-saving vaccines to the government under the Universal Immunisation Programme, including Pneumococcal, IPV and Rotavirus, Singh mentioned in his letter.

The Pune-based firm is one of the companies which supply BCG vaccines to the government.

"Our government is committed to eliminating TB. The vision of TB-free India has been energised by the clarion call of the prime minister to end TB from our country by 2025, five years ahead of the Sustainable Development Goal of ending TB," Singh mentioned in his letter.

"Under the leadership of our CEO Adar C Poonawalla, our firm is committed to making available a safe, efficacious and high-quality world-class TUBERVAC-rBCG vaccine for newborns, children, adolescents and adults at an affordable price," an official source quoted Singh as having said in the application.

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

The number of tuberculosis cases in India has seen a 19 per cent rise in 2021 over the previous year, and there has been an increase in the mortality rate due to all forms of TB between 2019 and 2020 by 11 per cent, according to the annual TB report released by Union Health Minister Mansukh Mandaviya on Thursday.

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