The permission has been granted after the Monitoring board reviewed the data of the 50 individuals who have been vaccinated so far at different clinical sites including AIIMS, New Delhi, AIIMS Patna and PGIMS, Rohtak.
The indigenous Covid-19 vaccine candidate of the country Covaxin has passed another hurdle with the Data and Safety Monitoring Board (DSMB) allowing the clinical sites where the human trials are being conducted to go ahead with more participants, according to Indian Express report. The permission has been granted after the Monitoring board reviewed the data of the 50 individuals who have been vaccinated so far at different clinical sites including AIIMS, New Delhi, AIIMS Patna and PGIMS, Rohtak.
Reading the development, Dr Savita Verma, Principal Investigator for Covaxin trial at Pandit Bhagwat Dayal Sharma Post Graduate Institute of Medical Sciences (PGIMS) Rohtak told IE that the development means that the vaccine has been found to be safe by the Monitoring board to be administered to more patients and in larger doses. After submitting the data of about 20 volunteers who were administered the vaccine at the institute, the PGIMS has now screened and administered the vaccine to another 15 volunteers.
Explaining the rationale behind initially testing the vaccine on a very few candidates, Dr Verma said that in order to check whether the vaccine is safe or not, it is only administered to a small group of people and that too in very small doses. She also added that there always remains a possibility of an adverse reaction of the vaccine or some allergy as nobody is sure how the body reacts. She further said that the same batch of 20 individuals who have been vaccinated for the first round will be given the second dose on July 31.
Confirming the development with the Indian Express, another principal investigator at another clinical site said that the decision of the Monitoring Board was communicated to them via email. With the development the path for large scale human trials of the vaccine has been cleared.