New Delhi, July 16
Zydus Cadila’s move to begin human trials of his locally developed vaccine candidate for COVID-19 is an important milestone for an ‘Atmanirbhar Bharat,’ Department of Biotechnology secretary Renu Swarup said Thursday.
Zydus Cadila said Wednesday that he has started phase 1 and 2 clinical trials of his candidate for the COVID-19 vaccine. ZyCoV-D, the plasmid DNA vaccine designed and developed by Zydus, has been partially funded by the Department of Biotechnology under the National Biopharmacy Mission.
This makes it the first vaccine developed in the country for COVID-19 to be administered to humans in the country, the DBT secretary said in a statement.
Swarup said development is also a breakthrough for the scientific community.
“This is an important milestone for Atmanirbhar Bharat when Zydus begins human clinical trials for the vaccine developed in the country. We hope that the vaccine will continue to show positive results, as it has done so far in the preclinical phase, where it was found to be safe, immunogenic and well tolerated, ”he said.
The multi-center study will evaluate the adaptive dose escalation of phases 1 and 2 to assess the vaccine’s safety, tolerability and immunogenicity, according to the release.
ZyCoV-D and COVAXIN, developed by the city-based Bharat Biotech in collaboration with the Indian Council for Medical Research, are the only two vaccine candidates who have received the go-ahead from the drug regulatory body for human trials.
“This partnership with Zydus serves to meet the country’s need for a vaccine to combat the dreaded pandemic that has put one billion people at risk,” Swarup said.
Such research efforts will help the country develop preventive strategies for future disease outbreaks as well. They exemplify the government’s focus on creating an ecosystem that encourages and encourages new product innovation to make real, measurable changes to the issues most relevant to our society, Swarup added.
Zydus Cadila President Pankaj Patel said starting human trials is a very important step in fighting the pandemic and that it will help the nation fight the challenge of health care.
In the preclinical phase, the vaccine was found to elicit a strong immune response in multiple animal species, including mice, rats, guinea pigs, and rabbits.
Antibodies produced by the vaccine were able to neutralize the wild-type virus in the virus neutralization assay, indicating the protective potential of the vaccine candidate.
No safety concerns were observed for the vaccine candidate in repeated dose toxicology studies by both intramuscular and intradermal routes of administration. In rabbits, up to three times the expected human dose was found to be safe, well tolerated and immunogenic, the DBT statement added. PTI
