"All the subjects in Phase I clinical trial were closely monitored in a clinical pharmacological unit for 24 hours post dosing for safety and for 7 days thereafter and vaccine was found to be very safe. We now begin the Phase II clinical trials and look forward to evaluating the safety and immunogenicity of the vaccine in a larger population," said Pankaj Patel, chairman, Zydus Cadila. The seven-day safety of the vaccine in all the subjects enrolled in the Phase I clinical trial has been endorsed by the independent Data Safety Monitoring Board (DSMB), constituted to oversee the safety aspects of the clinical trial, said Zydus.
Experts say if successful, Zydus's vaccine will be easy to make as it uses the plasmid DNA platform. A plasmid is a small DNA molecule within a cell that is physically separated from chromosomal DNA and can be replicated independently. When the plasmid DNA is introduced into the host cells, it translates into viral protein and elicits a strong immune response.
It is safer since it is a non-replicating and non-integrating plasmid carrying the gene of interest. Also, no vector response or infectious agents are used in the development technology. It is easy to make with minimal biosafety requirements (BSL-1) and has lower cold chain requirements, making it easy for transportation to remote regions. Further, the platform can be rapidly used to modify the vaccine within couple of weeks in case the virus mutates.
Zydus had developed India's first swine flu vaccine in 2010, and later a tetravalent seasonal influenza vaccine and a Varicella vaccine.
Among half-a-dozen promising COVID-19 vaccine projects are underway in India, and at least three have reached clinical trial stage. Hyderabad-based Bharat Biotech and Indian Council of Medical Research (ICMR)'s Covaxin has completed its phase I study in 11 sites and is starting the second phase study. Serum Institute of India has also been given a go ahead by the Indian drug regulator to start the final phase II/III trials of the Oxford-Astra Zeneca vaccine in India.
Zydus Cadila is also developing a vector platform based vaccine. Serum Institute is researching a BCG vaccine, besides a collaborative programme with a US partner. Companies like Biological E and Hester Biosciences are also trying to develop COVID-19 vaccine. Drug major Wockhardt has announced an agreement with the UK Government to manufacture vaccines, mainly being developed by Oxford-Astra Zeneca and GSK-Sanofi research programmes.
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