Zydus Cadila's COVID Vaccine Approved in India; Was Tested on Children Above 12

PM Modi lauded this development in a tweet.

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."

The vaccine is the "world's first and India's indigenously developed DNA-based vaccine for COVID-19 to be administered in humans, including children and adults, 12 years and above," the Ministry of Science and Technology said in a statement.

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.

"This 3 dose vaccine which when injected produces the spike protein of the SARS-CoV-2 virus and elicits an immune response, which plays a vital role in protection from disease as well as viral clearance. The plug-and-play technology on which the plasmid DNA platform is based can be easily adapted to deal with mutations in the virus, such as those already occurring."

Ministry of Science and Technology

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.

Interim results from phase-III clinical trials, showed a primary efficacy of 66.6 percent for symptomatic RT-PCR positive cases.

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)."

Dr Renu Swarup, secretary, DBT, and chairperson of Biotechnology Industry Research Assistance Council, said, “It is a matter of great pride that today, we have the EUA for the world’s first DNA COVID-19 vaccine ZyCoV-D by Zydus."

Health Minister Mansukh Mandaviya too, in a Twitter thread, dubbed the approval “double good news for the nation”.