Ahmedabad-based Zydus Cadila on Wednesday said it has begun the adaptive phase-I and II human trials of its plasmid DNA vaccine for Covid-19.The company said in the preclinical stage the vaccine was found to be safe, immunogenic and well-tolerated. It was also able to produce neutralising antibodies in animal studies, a key requirement for a vaccine. In the phase-I and II trials, the company will assess the safety, tolerability and immunogenicity of the vaccine.
“The puzzle on our new vaccine will be solved after the Phase-III trials … we are hopeful that if all goes well, the vaccine will be out in the first half of 2021,” chairman Pankaj Patel told ET. The DNA vaccine platform of the company provides ease of manufacturing the vaccine with minimal biosafety requirements. 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.
The vaccine will be tested for safety, efficacy, will compared with place.Zydus has received permission from the Drug Controller General of India (DCGI) permission to initiate Adaptive Phase I/II human clinical trials of its vaccine developed at its Vaccine Technology Centre in Ahmedabad based on encouraging pre-clinical data.
In the pre-clinical phase, the company said the vaccine was found to elicit a strong immune response in multiple animal species like mice, rats, guinea pigs and rabbits and 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.