Phase-2 trials of Bharat Biotech vaccine to begin in September

As reported by India Today, the phase I trial for the COVID 19 vaccine made by Bharat Biotech is complete and the Phase II of this trial is going to commence in September. In the first phase of the trial, the vaccine, known as Covaxin, is safe for human usage.

Details of the Phase I Trial

The Phase I Trial for the vaccine was conducted in 12 centres and out of the 12 centres, 11 have reported positive results for the vaccine. The trial in the last centre i.e. the All India Institute of Medical Sciences, New Delhi, is still to be completed and it is expected to be over soon. Initially, AIIMS Delhi was supposed to try the vaccine on 100 candidates but later it was brought down to only 16. The Phase I Trial of the vaccine was conducted on 375 volunteers across the 12 centres.

Report of the Phase I Trial

The preliminary results of the Phase I trial of the vaccine showed that it is safe for use. After the first dosing, two patients reported some fever-pertaining symptoms but they got better within a few hours of monitoring without any kind of medical intervention. The official report is yet to be submitted by the company. Once that is done, the preparation for the Phase II trial will commence in September 2020.

Vaccine Development in India

In India, two companies have entered into agreements for development of COVID 19 vaccines in the country. Biological E has signed an agreement with Johnson & Johnson and Baylor College of Medicine. On the other hand, Serum Institute of India, the largest manufacturer of vaccines by volume in the world, has entered into an agreement with AstraZeneca which is developing a vaccine with Oxford University and US-based Novavax. These are in their Phase III human trials. In the meantime, Russia has developed the first vaccine for COVID 19 named as Sputnik V on August 12, 2020.




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