Zydus Cadila's move to begin human trials of its indigenously developed vaccine candidate for COVID-19 is an important milestone for an 'Atmanirbhar Bharat', Department of Biotechnology Secretary Renu Swarup said on Thursday. Zydus Cadila on Wednesday said it has initiated Phase 1 and 2 clinical trials of its COVID-19 vaccine candidate. ZyCoV-D, the plasmid DNA vaccine designed and developed by Zydus, has been partially funded by the Department of Biotechnology under the National Biopharma Mission.
This makes it the first indigenously developed vaccine for coronavirus to be administered in humans in the country, the DBT secretary said in a statement. Swarup said the development is also a big leap forward for the scientific community.
"This is an important milestone for Atmanirbhar Bharat as Zydus begins human clinical trials for the indigenously developed vaccine. We hope that the vaccine continues to show positive outcomes as it has done so far in the pre-clinical phase where it was found to be safe, immunogenic and well tolerated," she said.
The adaptive phase 1 and 2 dose escalation, multi-centric study will assess the safety, tolerability and immunogenicity of the vaccine, the statement said. ZyCoV-D and COVAXIN, developed by city-based Bharat Biotech in collaboration with Indian Council of Medical Research, are the only two vaccine candidates to have got a nod from the drug regulatory body to conduct human trials.
"This partnership with Zydus is to serve the country's need for a vaccine to fight the dreaded pandemic which has put a billion people at risk," Swarup said. Such research endeavours will help the country develop preventive strategies for future disease outbreaks as well. They exemplify the government's focus on creating an ecosystem that nurtures and encourages new product innovation to make real and measurable changes to issues most relevant to our society, Swarup added.
Zydus Cadila chairperson Pankaj Patel said the commencement of human trials is a very important step in the fight against the pandemic and one that will help the nation combat the healthcare challenge. 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 neutralise the wild type virus in virus neutralisation 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, the DBT statement added.