BENGALURU: Indian drugmaker Zydus Cadila is seeking Emergency Use Authorisation (EUA) approval from the Drugs Controller General of India (DCGI) for the launch of their DNA vaccine for 12 years old and above, the pharma firm said.
The vaccine has completed the third phase of the trial, it added.
Zydus Cadila applies for Emergency Use Authorisation (EUA) seeking approval from the Drugs Controller General of India (DCGI) for the launch of their DNA vaccine for 12 years & above. The vaccine has completed the third phase of trial.#COVID19 pic.twitter.com/LDlsSkG3zF
— ANI (@ANI) July 1, 2021
The company said that it has applied to the country`s drug regulator for emergency use approval of its COVID-19 vaccine and that it plans to manufacture up to 120 million doses of the shot annually.
Coronavirus cases in India have dropped from a devastating peak in April and May but experts have warned of a third wave and reiterated that widespread vaccination remains one of the best defences against the pandemic.
An approval for COVID vaccine developed by Zydus – ZyCoV-D – would make it the fifth vaccine authorized for use in India, after Moderna, AstraZeneca and partner Serum Institute of India`s Covishield, Bharat Biotech`s Covaxin, and Sputnik V developed by Russia`s Gamaleya Institute.
ZyCoV-D showed safety and efficacy in a late-stage trial with more than 28,000 volunteers across the country, including about 1,000 subjects in the 12-18 year age group, Zydus said.
The study was carried out “during the peak of second wave of COVID-19 in India, reaffirming the vaccine`s efficacy against the new mutant strains especially the Delta variant,” Zydus said in a statement.