Indian central drug regulator’s subject expert committee (SEC) has recommended granting emergency use approval (EUA) to Zydus Cadila’s three-dose Covid-19 vaccine, the ministry of science and technology said on Friday, citing sources. The expert committee has also asked the manufacturer to submit additional data for the 2-dose regimen of its vaccine.
ZyCoV-D is a first of its kind DNA vaccine that produces the spike protein of the SARS-CoV-2 to elicit an immune response. It is an intradermal vaccine that has to be applied using a ‘needle-free injector’, which the manufacturer says will help in reducing side effects.
Cadila Healthcare Ltd, an Ahmedabad-based generic drug maker, had applied for EUA of its vaccine ZyCoV-D on July 1, based on an efficacy rate of 66.6% in a late-stage trial conducted on more than 27,000 volunteers nationwide, in over 50 trial centres. This vaccine has also been tested on 1,000 children above the age of 12. The company had said earlier that the two-dose regime works as well as the three-dose regime, and has submitted relevant data on this for further scrutiny.
The SEC might also deliberate on the Russian-made single-dose vaccine, Sputnik V, called Sputnik Light, Hindustan Times had reported on August 17. To fast-track quality checks of Covid-19 vaccine batches, the Centre has approved the setting up of another lab National Institute of Animal Biotechnology in Hyderabad.
