The Center has approved Covaxin coronavirus vaccine from Hyderabad-based Bharat Biotech for phase 2 clinical trials starting on September 7.
The trials will be carried out with 380 volunteers, according to a letter sent to Bharat Biotech International by Dr S Eswara Reddy, Joint Controller of Drugs of India. In the first phase of the Covaxin trial, about 375 participants were studied at 12 sites.
“We inform you that the proposal of the subject was examined in consultation with the experts of the SEC (Covid-19) held through a virtual meeting on September 3, in which the committee recommended for the realization of Phase II part of clinical trials with 380 participants subject to the condition that the screening time of the participants is reviewed in 4 days, “said the General Directorate of Health Services in a statement.
In the first phase of the vaccine trial, blood samples collected from volunteers who received the vaccine were monitored for side effects. According to Dr. E Venkata Rao, principal investigator of the trial at the Institute of Medical Sciences (IMS) and SUM Hospital, college of medical sciences, there were no side effects.
IMS and SUM Hospital is one of 12 medical centers in the country chosen by the Indian Council for Medical Research (ICMR) to conduct the human trial of the vaccine developed by Hyderabad-based Bharat Biotech.
Covaxin is one of the pioneers in the race for a Covid-19 vaccine in India. It is an “inactivated” vaccine: it works by injecting doses of the virus that have died in order to incite the body to produce antibodies against it without the virus posing a threat.
Each stage of the clinical trial of a vaccine tests its safety and ability to develop an effective immune response. Phase 1 focuses on determining safety and dosage in a small group of healthy participants, while Phase 2 looks at the efficacy of the vaccine. The third phase looks at these issues in a much larger population that would represent a larger demographic.
(with contributions from the agency)
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