NEW DELHI: The Drug Controller General of India (DCGI) has granted permission for human trials of a Covid-19 vaccine candidate developed by pharmaceutical major Zydus Cadilla, within days of issuing a similar approval to Hyderabad-based Bharat Biotech’s Covaxin.
In a statement released on Friday, the Ahmedabad based company said that it received permission from the DCGI- Central Drugs Standard Control Organisation for phase I and II trials of the potential plasmid DNA vaccine after “successfully completing preclinical phase.”
The development comes even as the Indian Council of Medical Research wrote to directors of 12 hospitals and research institutions in 10 states asking them to fast track the clinical trial approvals for Covaxin— developed from SARS CoV 2 strain isolated at the National Institute of Virology, Pune.
In the letter, the ICMR DG Dr. Balram Bhargava, while warning the hospitals against any delays, said that the subject enrollment should be completed by July 7 as the government is looking to launch the vaccine by August 15.
Zydus meanwhile said that its vaccine candidate for ZyCoV-D has been developed indigenously at the firm’s Vaccine Technology Centre and was found to elicit a strong immune response in multiple animal species such as mice, rats, guinea pigs, and rabbits.
“The antibodies produced by the vaccine were able to completely neutralize the wild type virus in virus neutralization assay indicating the protective potential of the vaccine candidate,” said the pharma company.
“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.”
It added that clinical GMP batches of the vaccine candidate have already been prepared and the clinical trials will begin this month in over 1000 subjects.
“With ZyCoV-D, the company has successfully established the DNA vaccine platform in the country using non-replicating and non-integrating plasmid carrying the gene of interest making it very safe,” Zydus said.
It also added that due to absence of any infectious agent, the platform provides ease of manufacturing the vaccine with minimal biosafety requirements (BSL-1).
“The platform is also known to show much improved vaccine stability and lower cold chain requirements making it easy for transportation to remote regions of the country. Furthermore, the platform can be rapidly used to modify the vaccine in a couple of weeks in case the virus mutates to ensure that the vaccine still elicits protection,” said the firm.