Zydus Cadila's 3-Dose COVID Vaccine Gets Approval from India's Drugs Regulator. Image used for representational purposes.
(Photo Courtesy: iStock)
Zydus Cadila's three-dose COVID-19 vaccine, ZyCoV-D, has received emergency use authorisation (EUA) from the Drugs Controller General of India (DGCI), the Centre announced on Friday, 20 August.
Lauding this development Prime Minister Narendra Modi tweeted:
"The approval for world’s first DNA-based ‘ZyCov-D’ vaccine of Zydus Cadila is a testimony to the innovative zeal of India’s scientists. A momentous feat indeed."
ZyCoV-D is the sixth vaccine approved for use in India after Serum Institute's Covishield, Bharat Biotech's Covaxin, Russia's Sputnik V, and the US-made Moderna and Johnson & Johnson.
Earlier, it was reported that the Subject Expert Committee (SEC) of the Central Drugs Standard Control Organisation (CDSCO) had recommended giving emergency approval to the vaccine.
ZyCoV-D trial has been the largest vaccine trial so far in India for COVID-19, with 28,000 volunteers.
The ministry further said, "The vaccine had already exhibited robust immunogenicity and tolerability and safety profile in the adaptive phase I/II clinical trials carried out earlier. Both the phase I/II and phase-III clinical trials have been monitored by an independent Data Safety Monitoring Board (DSMB)."
Health Minister Mansukh Mandaviya too, in a Twitter thread, dubbed the approval “double good news for the nation”.
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