Zydus COVID-19 vaccine got approval from DCGI to starts human dosing of its vaccine ‘ZyCoV-D’

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India’s second possible vaccine against COVID-19, ZyCoV-D, is all set to start its human trial this month, the company said. The trials will be conducted on 1,000 volunteers across multiple sites in the country. Last week, Zydus Cadila group received approval from Drug Controller General of India (DGCI) to initiate phase 1 and phase 2 human clinical trials of possible COVID-19 vaccine in India.

Speaking on the development, Chairman, Zydus Cadila, Mr. Pankaj R. Patel said, “This is an all important
step in our fight against COVID-19. We acknowledge the support of National Biopharma Mission,
BIRAC, Department of Biotechnology, Govt. of India and regulatory agencies ICMR and DCGI in the
development of ZyCoV-D vaccine candidate. We look forward to the Adaptive Phase I/IIclinical studies
and gathering important data on ZyCoV-D in the months ahead.”

Dr Harsh Vardhan tweeted ” ZyCoV-D, the plasmid DNA vaccine designed & developed by @ZydusUniverse & partially funded by  @DBTIndia has initiated Phase I/ II clinical trials in healthy subjects, making it the first indigenously developed vaccine for #COVID19 to be administered in humans in India. @IndiaDST

In the pre-clinical phase, the vaccine was found to elicit a strong immune response in multiple animal
species like mice, rats, guinea pigs and rabbits. The antibodies produced by the vaccine were able to
neutralize the wild type virus in virus neutralization assay indicating the protective potential of the vaccine
candidate. No safety concerns were observed for the vaccine candidate in repeat dose toxicology studies
by both intramuscular and intradermal routes of administration. In rabbits, up to three times the intended
human dose was found to be safe, well tolerated and immunogenic.

Another possible vaccine against COVID-19, Covaxin, will soon start human trial on over 1,100 people in two phases, according to a report. Bharat Biotech, an unlisted Indian vaccine maker, received regulatory approval to start human clinical trials for its experimental shot. The phase 1 trial of Covaxine is scheduled to start next week. The company has planned to enroll 375 people in the first phase of clinical trials, an Indian Council for Medical Research (ICMR) spokesperson told.

Though the vaccine involve govt. labs but both the vaccines have been designed and developed by private players and no govt. or publicly funded institution’s scientist(s) have contributed to the design and development or science of vaccine, as per the press releases of ICMR and DBT. For Covaxin, ICMR just shared the starting material and for ZyCoV-D, DBT just provided the funding support under National Biopharma Mission.

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