Govt panel to review SII's EUA application for TB vaccine

Acrucial meeting of the subject expert committee (SEC) of the CDSCO will be held on Tuesday to consider granting emergency-use authorization (EUA) to Serum Institute of India’s (SII) recombinant BCG (rBCG) vaccine for the prevention of tuberculosis, according to official sources.

The Central Drugs Standard Control Organisation (CDSCO) is the drug regulator of India.

The EUA application was submitted to the Drugs Controller General of India (DCGI) on March 22 by Prakash Kumar Singh, the director of government and regulatory affairs at the SII.

India’s TB immunization program currently offers BCG vaccination at birth or as early as possible till one year of age.

The 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 that supply BCG vaccines to the government.

”Our government is committed to eliminating TB. The vision of a TB-free India has been energized 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 CEO Adar C Poonawalla, the SII 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 had quoted Singh as having said in the application.

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