Zydus Cadila seeks DCGI nod for emergency use of its DNA vaccine for 12+ age
Gujarat-based pharmaceutical company Zydus Cadila has applied to the Drugs Controller General of India (DCGI), India's top drug regulator, seeking emergency use approval of ZyCoV-D, its DNA vaccine against coronavirus disease (Covid-19) for those aged 12 years and above, news agencies reported on Thursday. The company presented interim results from Phase-III clinical trials in over 28,000 volunteers, Reuters said, adding that the study demonstrates safety and efficacy in the interim data.
The Phase-III clinical trial data from Zydus Cadila shows that ZyCoV-D is safe for children in the age group of 12 to 18 years. The company has planned to manufacture 100-120 million doses of Covid-19 vaccines annually. The second indigenous vaccine after Bharat Biotech's Covaxin, ZyCoV-D is a three-dose vaccine. According to Zydus Cadila, the three doses of Zycov-D are to be administered on day 0, day 28, and day 56. However, the company is also working on a two-dose vaccine.
The DCGI had granted Cadila Healthcare Limited permission to conduct human trials for ZyCoV-D back in July last year, when the company had said that its vaccine will hit the markets by June 2021. The study was carried out "during the peak of the 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.
Earlier, the pharmaceutical company was in the news for being one of the several Indian firms which received licensing agreements from Gilead Sciences to produce the anti-viral drug remdesivir.
An approval for Zydus' vaccine, ZyCoV-D, would make it the fifth Covid-19 vaccine authorised 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.
Coronavirus cases in India dropped from a devastating peak in April and May, however, experts have warned of a third wave and reiterated that widespread vaccination remains one of the best defenses against the pandemic.
(With inputs from Reuters)