Screening begins for human trials of Covaxin

New Delhi, July 20: Health screening started at the All India Institute of Medical Sciences (AIIMS) here on Monday for human testing of Coronavirus (Covid-19) vaccine ‘Covaxin’ of Bharat Biotech, a leading biotechnology company.

Dr Sanjay Rai of the Department of Community Medicine, who is spearheading the human trials of Covaxin at AIIMS, told UNI that health screening of selected candidates was been done today. Several types of medical tests have been done for the candidates involved in human trials to find out that they are not Corona infected nor are they suffering from diseases like blood pressure, diabetes among others.

After the medical report, they will be given their first dose of Covaxin on the following Thursday or Friday. Only healthy people will be included in this test. This test will not be done on pregnant women.

He also stated that so far more than 1,800 people have volunteered by registering for the human clinical trial of indigenously-developed vaccine.

AIIMS Delhi is among the 12 institutes selected by the Indian Council for Medical Research (ICMR) for conducting phase I and II human trials of Covaxin.

 

Dr Rai said a total of 1,125 persons will be given a dose of the vaccine in both stages of human trials. In the first phase, 375 persons are to be given a dose of Covaxin, of which AIIMS Delhi is conducting tests on 100 persons.

As to how many people will be tested in AIIMS Delhi in the second phase is yet to be decided but in the second phase also AIIMS itself will have the largest sample size.

Bharat Biotech, the vaccine manufacturer, started human trials of Covaxin on July 15. Human trials have started in Rohtak PGI in Haryana and AIIMS Patna. AIIMS New Delhi is to test it on 100 people during the first phase to see if this vaccine is safe or not and how much dosage will be effective and how many doses the patient needs.

 

The first phase is to be conducted on candidates between the ages of 18 and 55. The second phase will test three formulations of Covaxin and is to be conducted on a large-scale, covering 750 candidates. There will be candidates between the ages of 12 and 65 years.

Covaxin is being developed in collaboration with Bharat Biotech, Indian Institute of Medical Research (ICMR) and the National Institute of Virology, Pune. The Drug Controller General of India has given its approval for human testing.

 

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