Zydus plans to initiate the
clinical trials of ZyCoV-D in July 2020 across multiple sites in India.
In
animal studies the vaccine was found to elicit a strong immune response in
multiple animal species like mice, rats, guinea pigs and rabbits.
Zydus, a part of the Cadila Healthcare group, on Friday
said its indigenously developed COVID-19 vaccine candidate - ZyCoV-D - has
successfully completed pre-clinical phase and has received permission from
Indian authorities to conduct human trials.
"Zydus has already manufactured clinical good
manufacturing practice (GMP) batches of the vaccine candidate and plans to
initiate the clinical trials in July 2020 across multiple sites in India in
over 1,000 subjects," the company said.
ZyCoV-D, developed at the
company's Vaccine Technology Centre in Ahmedabad, has now received permission
from the Drug Controller General of India (DGCI) - Central Drugs Standard
Control Organisation (CDSCO) to initiate phase I/II human clinical trials in
India, Cadila Healthcare said in a regulatory filing.
In animal studies 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 completely neutralise the wild type virus in virus
neutralisation assay indicating the protective potential of the vaccine
candidate, it said.
It further said 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.
Zydus said, with its
ZyCoV-D, it has successfully established the DNA vaccine platform in India
using non-replicating and non-integrating plasmid carrying the gene of interest
making it very safe.
The company claimed that
the vaccine candidate has no vector response and with absence of any infectious
agent, the platform provides ease of manufacturing the vaccine with minimal
biosafety requirements.
It is also known to show
much improved vaccine stability and lower cold chain requirements making it
easy for transportation to remotest parts of the country, it said.
"Furthermore, the
platform can be rapidly used to modify the vaccine in couple of weeks in case
the virus mutates to ensure that the vaccine still elicits protection," it
added.
The company now intends to
rapidly ramp up the production capacities of ZyCoV-D at multiple sites and
facilities to cater to Indian and global demand.
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