TB vax: Serum Institute seeks emergency-use authorization

TB vax: Serum Institute seeks emergency-use authorization

Subject: Science and tech

Section: COVID -19

Context:

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, said official sources on Sunday.

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 that supply BCG vaccine to the government.

Emergency use authorisation

• Vaccines and medicines, and even diagnostic tests and medical devices, require the approval of a regulatory authority before they can be administered. In India, the regulatory authority is the Central Drugs Standard Control Organisation (CDSCO).
• For vaccines and medicines, approval is granted after an assessment of their safety and effectiveness, based on data from trials. In fact, approval from the regulator is required at every stage of these trials. This is a long process, designed to ensure that a medicine or vaccine is absolutely safe and effective. The fastest approval for any vaccine until now — the mumps vaccine in the 1960s — took about four-and-a-half years after it was developed.
• In emergency situations, like the current one, regulatory authorities around the world have developed mechanisms to grant interim approvals if there is sufficient evidence to suggest a medical product is safe and effective. Final approval is granted only after completion of the trials and analysis of full data; until then, emergency use authorisation (EUA) allows the medicine or the vaccine to be used on the public.