Zydus Cadila applies for emergency use authorisation of its COVID-19 vaccine
An approval for Zydus’ vaccine, 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.
Zydus Cadila on Thursday said it has applied to the Drugs Controller General of India for the emergency use approval of its Covid-19 vaccine. It's further said that it plans to manufacture up to 120 million doses of the shot annually.
The vaccine is to be made available for 12 years and above. If DCGI approves, this will be the fifth vaccine to be approved for Indian use, after Serum Institute's Covishield, Bharat Biotech's Covaxin, Russia's Sputnik V and US Moderna.
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 to the stock exchanges.
The Centre has been banking on domestic vaccine manufacturers Biological E and Zydus Cadila to bolster dwindling vaccine supplies. The government has been looking to procure a total of 135 crore doses: Covishield (50 crore), Covaxin (40 crore), Bio E Subunit vaccine (30 crore), Zydus Cadila DNA vaccine (5 crore) and Sputnik V (10 crore). The procurement of Bio E Subunit vaccine and Zydus Cadila DNA vaccine will be subject to approval.
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 defences against the pandemic.
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