Gujarat-based pharmaceutical company Zydus Cadila on Friday said that it has received approval from the Drug Controller General of India to start phase one and two of human clinical trials of its coronavirus vaccine. Bharat Biotech’s Covaxin was the first vaccine in India to get permission for human trials.
The company said in a statement that its vaccine was found to elicit a “strong immune response” in 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,” Zydus Cadila said. “No safety concerns were observed for the vaccine candidate in repeat dose toxicology studies by both intramuscular and intradermal routes of administration.”
The pharmaceutical company added that it has already produced batches of the vaccine and will start the clinical trials across multiple sites in India in July, with over 1,000 subjects.
Hyderabad-based Bharat Biotech’s Covaxin, developed in collaboration with the Indian Council of Medical Research and the National Institute of Virology, was the first indigenous vaccine in the country to get a go-ahead for human trials. Covaxin trials are also scheduled to begin in July.
On Thursday, ICMR directed clinical trial sites of Covaxin to fast track approvals, saying that the vaccine was the government’s top priority. The top medical body said that it aims to launch the vaccine by August 15.
India reported over 20,000 coronavirus cases and 379 deaths on Friday morning. The country’s overall count rose to 6,25,544 and the toll reached 18,213. As many as 3,79,891 people have recovered so far.
No coronavirus vaccine has been approved yet for use anywhere in the world. The World Health Organization, however, had said last month that United Kingdom-based pharma firm AstraZeneca’s experimental vaccine was probably the leading candidate. The vaccine was developed by researchers at the University of Oxford.