The pace of the second wave of coronavirus in the country is now slowing down. The country is being vaccinated rapidly amid fears of a third wave of the pandemic. Drug maker Zydus Cadila on Thursday sought approval for the emergency use of its vaccine. After getting approval from the Drug Controller General of India (DCGI), immunization of children of 12+ years can be started.
The company has presented data from the Phase III trial of the vaccine, in which more than 28,000 volunteers participated. According to Reuters, the vaccine has stood on the standards of safety and efficacy in interim data.
Largest clinical trial for its vaccine in India
The company conducted the largest clinical trial for its COVID-19 vaccine in India so far in over 50 centers. This was also the first time that any COVID-19 vaccine has been tested in adolescent population in the 12-18 years age group in India.
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.
World’s Fir Plasmid DNA vaccine
Zydus Cadila said the world’s first Plasmid DNA vaccine for COVID-19 demonstrated safety and efficacy in the interim data of the largest vaccine trial so far in India for COVID-19.
3rd dose suggests 100% efficacy for moderate disease
The primary efficacy of the three doses vaccine was at 66.6 percent for symptomatic RT-PCR positive cases in the interim analysis. Whereas no moderate case of COVID-19 disease was observed in the vaccine arm post administration of the third dose suggesting 100 percent efficacy for moderate disease.
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.