The Serum Institute of India (SII) has applied to the Drugs Controller General of India (DCGI) seeking Emergency Use Authorisation (EUA) for its recombinant BCG (rBCG) vaccine for the prevention of tuberculosis, official sources said yesterday.
The EUA application was submitted on 22nd March by Prakash Kumar Singh, Director, Government and Regulatory Affairs, 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 vaccine to the government.
“Our government is committed to eliminate 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 leadership of our CEO Adar C Poonawalla, our firm is committed to make available a safe, efficacious and high-quality world-class TUBERVAC-rBCG vaccine for newborns, children, adolescents and adults at 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.
Edits by EP News Bureau