The recommendations of the Drugs Controller General of India (DCGI) on Zydus Cadila’s ZyCoV-D three-dose vaccine are likely to be out soon, NITI Aayog member VK Paul said on Friday. The Ahmedabad-based pharmaceutical firm had applied to the country’s drug regulator for emergency use approval of its vaccine last week and the data is being examined currently.
If scientific data suggests the vaccine is safe for children aged between 12-18 years, the doses can be used, he further said.
Zydus claims its vaccine is 66.6 per cent effective against symptomatic Covid cases and 100 per cent for moderate disease. It also says the vaccine is safe for children between 12 and 18 years. But its trial data is not peer-reviewed yet. The vaccine, which is in its second phase of trials, is a “plasmid DNA” vaccine that can be stored at 2-8 degree Celsius.
Zydus has said the vaccine, which is a three-course regimen, 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.
The drugmaker has said it is also evaluating a two-dose regimen for the shot and the immunogenicity results of the shorter course have been found to be comparable with the three-dose regimen.
The candidate, if approved, would become India’s second successful home-grown Covid-19 shot and help ease the country’s severe vaccine shortage.
Further, an approval for the vaccine, ZyCoV-D, would make it the fifth shot authorised for use in India. The country has already approved vaccines from Moderna, AstraZeneca and partner Serum Institute of India, Bharat Biotech, and Russia’s Gamaleya Institute.
Zydus said the study was carried out “during the peak of the second wave of COVID-19" in India and reaffirmed the vaccine’s efficacy against new mutant variants, especially, the Delta variant. However, it did not disclose efficacy rate against those variants.