New Delhi. Ahmedabad-based pharmaceutical company Zydus Cadila will submit additional data on its coronavirus vaccine, ZyCov-D, to the Drugs Controller General of India (DCGI) on July 23, a government official with knowledge of this told CNN-. . The drug regulator had earlier asked Zydus Cadila to submit more data related to the immunogenicity and safety of ZyCov-D, which is set to become the world’s first plasmid DNA vaccine for human use.
Sources said that the subject expert committee (SEC) of DCGI will examine the additional data, and if it is found satisfactory, a final approval may be given from DCGI in August. Zydus Cadila had earlier said that they could launch the vaccine within two months of getting approval. The pharmaceutical firm applied for an emergency use authorization for a three-dose DNA vaccine on July 1.
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Zydus has claimed that its vaccine is 66.6 percent effective on symptomatic patients and 100 percent effective in mild cases. It is also being said that this vaccine is effective on people aged 12 to 18 years. However, its trial data has not been reviewed yet.
Zydus Cadila will be India’s second vaccine
If approved, this vaccine will be India’s second indigenous vaccine and the fifth vaccine to be used in the country. India has already approved vaccines from Moderna, AstraZeneca and partner Serum Institute of India, Bharat Biotech and Russia’s Gamalya Institute.
ZyCov-D, which is being developed in partnership with the Department of Biotechnology and the Indian Council of Medical Research, can be stored at 2-8 °C and 25 °C for up to three months. Once approved, it will be an intra-dermal (between the skin and muscle) vaccine administered through a special needle-free injector. Currently licensed coronavirus vaccines are administered intra-muscularly.
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