Zydus Cadila expects to complete the first two phases of human clinical trials for its Covid-19 vaccine candidate, ‘ZyCov-D’, in the next three months, according to the chairman of the Ahmedabad-headquartered pharma firm. The trials will begin this month in over 1,000 patients across multiple sites, hotting up India’s race for a vaccine against the contagious virus that had caused a nationwide lockdown.
The Central Drugs Standard Control Organisation (CDSCO) late on Thursday approved Zydus Cadila’s application to move to human trials for ZyCov-D following the submission of promising results from animal testing. The development comes on the heels of the regulator’s approval to Hyderabad-based Bharat Biotech to move its Covid-19 vaccine candidate, Covaxin, to phase I and II trials.
The second vaccine candidate in the country to move to this stage, ZyCov-D is a plasmid DNA vaccine candidate narrowed down by Zydus Cadila from four other candidates the firm had been working on over the last three months.
DNA vaccines use genetically engineered plasmids—a type of DNA molecule—that are coded with the antigen against which the immune response is to be built. The DNA sequence injected would match that of the virus, helping the body build antibodies against it.
“We started working in early March…we selected one of them which was good,” said Zydus Cadila chairman Pankaj R Patel in an interview to The Indian Express. “Then, once it was completely developed, we administered that to animals to check the immune response and we got a good response,” he said. The company found that the antibodies developed from the vaccine in animals were “good to kill the virus”, he said.
Zydus, which has already manufactured batches of the vaccine candidate, plans to follow an adaptive clinical trial protocol, which allows the company to move straight from phase I to phase II trials without much time in between.
“We will take about three months to complete the Phase I and II clinical trials, after which we will approach the Drug Controller General of India for their consideration…Whatever the regulator will tell us, we will follow,” said Patel.
When asked if the firm planned to push for emergency approvals of its vaccine candidate, which would allow it to launch its vaccine without conducting phase III trials, he said the next course of action will only be decided once enough data was generated from the first two trials.
ZyCov-D is among two potential Covid-19 vaccines by the drugmaker that is being watched globally. The World Health Organisation has listed the candidate in its draft landscape of Covid-19 vaccine candidates.
Zydus in a statement earlier on Friday said it intended to “rapidly” ramp up production capacities of ZyCov-D at multiple sites and facilities to cater to the Indian and global market
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