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Zydus Cadila's Covid-19 vaccine likely to get emergency approval by this week: Report
Zydus Cadila is planning to manufacture 100-120 million doses of the vaccine annually.
Zydus Cadila's needle-free vaccine against the coronavirus disease (Covid-19) is expected to get approval for emergency use in India by this week, news agency ANI reported.
If approved, it will be the country's second indigenous vaccine after Bharat Biotech's Covaxin. Overall it will be the sixth vaccine approved by the India to inoculate its 1.3 billion population. Apart from Covaxin, the country is using Serum Institute of India’s Covishield, the Russian-made Sputnik V, Moderna vaccine and Johnson & Johnson's single-dose vaccine in the nationwide inoculation drive.
On July 1, the Ahmedabad-based pharmaceutical company submitted an application for the emergency use authorisation to the Drugs Controller General of India (DCGI). The ZyCoV-D will be a three-dose regimen.
Zydus Cadila is planning to manufacture 100-120 million doses of the vaccine annually. It has conducted the largest clinical trial for its Covid-19 vaccine in India so far in over 50 centres. It had presented interim results from Phase-III clinical trials in over 28,000 volunteers. The study is said to have demonstrated safety and efficacy in the interim data.
The company has also tested the jab in the adolescent population in the 12-18 years age group in India, according to its regulatory filing. The data has shown that ZyCoV-D is safe for children in the age group of 12 to 18 years.
According to Zydus Cadila, the three doses of ZyCoV-D are to be administered on day 0, day 28, and day 56. The company is also said to be working on a two-dose vaccine.
