Procedural preparations have almost been completed for conducting clinical trials on corona vaccine ‘Covaxin’ being developed by the Hyderabad-based Bharat Biotech at Nizam Institute of Medical Sciences (NIMS).
According to authorities from NIMS, the process of conducting clinical trials for the coronavirus vaccine ‘Covaxin’ has almost been completed and as many as 60 people have been selected as subjects at the hospital who are expected to undergo trial studies for the newly developed home grown corona vaccine Covaxin.
Two leading Indian companies Bharat Biotech International and Zydus Cadila Healthcare have received nod from the Drug Controller General of India (DCGI) for conducting clinical trials on human beings for two vaccine candidates. Based on the toxicity data of animal studies submitted to the Indian regulator, the Indian Medical Research Council (ICMR) has established 12 clinical trial centers across India and NIMS at Hyderabad is one among those centers.
“As per the directions of the government, we have made all necessary arrangements to ensure smooth conduct of clinical trials on the selected subjects. All procedural formalities have been completed and the blood samples of the subjects have also been collected and sent to designate laboratory in Delhi for finalizing the subjects. Once the report comes, we are expecting the first dose of vaccine to come in the next one or two days and it may be tested on 60 subjects at NIMS,” informed a reliable source.
It is learnt that as many as 1,000 volunteers have approached to take part in the clinical trials for the newly developed Covaxin vaccine across the country, among them, the ICMR is expecting to conduct clinical trials on 375 selected people for the first dose of the vaccine at the 12 designated hospitals across India.
While referring to the clinical trials of two vaccine candidates from two leading Indian vaccine makers in India, Dr. Balram Bhargava, Director General of ICMR said that India is already a leading vaccine manufacturing country in the world. “And at this juncture when the country is reeling under deadly viral pandemic, it is our responsibility to expedite the process of clinical trials and to make sure we come out with a permanent solution to tackle the contagious virus and save the world from its death clutches,” observed the ICMR DG.
“As both the Bharat Biotech and Zydus Cadila Healthcare have successfully submitted their animal toxicity studies conducted on rats, mice and rabbits, the DGCI has given the nod for the clinical trials on humans. SO, we have decided to expedite the same to bring out an effective treatment for the deadly virus at the earliest,” informed Dr. Bhargava.
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