Human clinical trials for Covid-19 vaccine started in India: ICMR


Human clinical trials for a Covid-19 vaccine have been started in the country with approximately 1,000 volunteers participating in the exercise for each of the two locally developed vaccine candidates, ICMR said Tuesday.

Since India is one of the world’s largest vaccine producers, it is the country’s “moral responsibility” to accelerate the vaccine development process to break the coronavirus transmission chain, said ICMR Director-General Dr. Balram Bhargava, referring to the two vaccine candidates. indigenously developed.

Two vaccines, one developed by Bharat Biotech International Limited in collaboration with the Indian Council of Medical Research and the other by Zydas Cadila Healthcare Ltd, have been allowed by the General Drug Controller of India (DCGI) to enter the first and second phase of human beings. . clinical trials.

There are two Indian vaccine candidates who have undergone successful toxicity studies in rats, mice, and rabbits, and these data were sent to DCGI, after which they both obtained clearance to begin an early phase of human trials earlier this month. Bhargava said at a press conference.

“Two indigenous indigenous candidate vaccines obtained authorization to begin early-phase human trials this month.

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“They have prepared their sites and are conducting the clinical study of approximately 1,000 human volunteers each at different sites. They are trying to do early clinical testing for these two indigenous vaccine candidates,” said Bhargava.

“… it is a moral duty to develop them as quickly as possible because more than half a million people have succumbed to the disease worldwide. Therefore, speeding up this vaccine becomes very important,” he said.

A recent letter from Bhargava predicting the release of a Covid-19 vaccine by August 15 had created quite a stir with many experts who claim that such a timeline may not be realistic.

Bhargava stated that India is considered the “world’s pharmacy”, saying that 60 percent of the drugs used in the United States are of Indian origin.

“The important fact that is unknown is that 60 percent of vaccines supplied in the world, be it Africa, Europe or Southeast Asia or anywhere, are of Indian origin,” he said.

India is perceived and is a major player in supplying vaccines to the world, Bhargava noted.

“Any vaccine candidate that is produced or developed anywhere in the world will eventually have to be expanded by India or China because these two are the leading vaccine producers in the world and that every developed nation or everyone trying to develop a vaccine is aware of it and therefore they are contacting India for distribution of the vaccine ultimately if it is developed, “he said.

Bhargava said that Russia had recently accelerated a vaccine, which has been successful in its early stages, and has also accelerated its development and has been applauded by everyone.

“The United States again, as you read today, has accelerated two of its vaccine candidates, and the United Kingdom is also studying how it can accelerate the candidate for the Oxford vaccine for human use.”

“From India’s perspective, we have two vaccine candidates. We are trying to do everything we can to speed it up and it is a moral duty that there are no delays for one day for regulatory approval of these vaccines so that we can interrupt transmission of virus as soon as possible, “Bhargava said.

He stressed that still 60 percent of the other vaccines, be it against polio, measles and rubella, are all manufactured in India and delivered to international agencies for supply to the world, so this it becomes an important aspect for India to accelerate its vaccine. development and work together to develop these vaccines for everyone.

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