Health

Human Trial of Covaxin Gathers Steam as Odisha Hospital Joins the Fray: 10 Points

by Satakshi-Gauri
Jul 29, 2020 12:02

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The human clinical trial of indigenously developed Covaxin, a possible vaccine against the novel coronavirus, began at an institute in Bhubaneswar on Monday, a senior official said.

Here's what we know about the indigenous vaccine so far:

1) The much-awaited trial of BBV152 COVID-19 vaccine or Covaxin commenced at the Institute of Medical Sciences and SUM Hospital in Bhubaneswar, one of the 12 centers selected by the Indian Council of Medical Research (ICMR) for conducting phase one and two of the process, the official at the facility said.

2) Covaxin, which is being developed by Bharat Biotech, was administered to several selected persons who had volunteered to be part of the crucial trial, Dr. E Venkat Rao, principal investigator of the trial process, told PTI.

3) The volunteers had undergone a rigorous screening procedure, he said, adding they were administered the vaccine strictly in accordance with the protocols laid down by the Drugs Controller General of India (DCGI), he said.

4) Apart from Bhubaneswar, the other institutes selected for the clinical trial are located in Visakhapatnam, Rohtak, New Delhi, Patna, Belgaum, Nagpur, Gorakhpur, Kattankulathur, Hyderabad, Arya Nagar, Kanpur, and Goa.

5) The first part of phase-1 of Covaxin human trial completed on Saturday at Post-Graduate Institute (PGI) of Medical Sciences, Rohtak, said Dr. Savita Verma, principal investigator of the vaccine trial team. "First part of phase-1 of vaccine trial (Covaxin) has been completed. 50 people across India were administered the vaccine and the results were encouraging. Six people were administered vaccine on Saturday under the second part of phase-1," she said.

6) The phase-I human clinical trial of Covaxin began at the AIIMS Delhi on Friday with the first dose of the injection given to a man, who is in his 30s. Already, over 3,500 volunteers have already registered themselves for the trial at AIIMS since last Saturday, of whom the screening of at least 22 people is underway, Dr. Sanjay Rai, Professor at the Centre for Community Medicine at AIIMS and the principal investigator of the study, said.

7) Phase I of the vaccine trial will be done on healthy people aged 18-55 years having no co-morbid conditions. Women with no pregnancy will also be selected to be a part of the trial in the first phase. In the second phase, 750 people will be recruited between 12-65 years, AIIMS Director Dr. Randeep Guleria had said.

8) There are three formulations of the vaccine, and each subject will be given any one of the formulations in two doses two weeks apart. The first 50 will get the lowest strength dose of the vaccine. If it is found to be safe in them, then it will be given to another 50 patients in high doses. COVID-19 vaccine candidate Covaxin, developed by the Hyderabad-based Bharat Biotech in collaboration with the ICMR and the National Institute of Virology (NIV).

9) The 12 institutes have been asked by the ICMR to fast track clinical trials of the vaccine. The ICMR earlier said that it is envisaged to launch the vaccine for public health use latest by August 15, 2020, after completion of all clinical trials.

10) At least seven Indian pharma companies are working to develop a vaccine against coronavirus as they join global efforts to find a preventive to check the spread of the deadly virus that has already infected more than 14 million globally. Bharat Biotech, Serum Institute, Zydus Cadila, Panacea Biotec, Indian Immunologicals, Mynvax, and Biological E are among the domestic pharma firms working on the coronavirus vaccines in India. Vaccines normally require years of testing and additional time to produce at scale, but scientists are hoping to develop a coronavirus vaccine within months because of the pandemic.

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