Soon, in Chennai, third phase of Covaxin trials to start
Posted on: 08/Oct/2020 9:30:49 AM
It has been a month since phase-2 human clinical trials began for indigenous Covid-19 vaccine or Covaxin. Now, Chennai based hospitals have begun calling for volunteers for phase-3 trials. In the phase-3 trials, the efficacy of the vaccine would be tested.
It must be recalled that SRMIST in Kattankolathur near Chennai was one of the 12 institutions that was selected by ICMR for conducting trials of the vaccine developed by Bharat Biotech (Hyderabad) in association with ICMR and National Institute of Virology.
It was brought to light by Dr. Satyajit Mohapatra, principal investigator for the trials at the hospital that phase-3 trials might start in 2 weeks after getting the approval and the protocol to be followed.
Important information collected is that unlike phase-1 and phase-2 trials that was carried out in a smaller population the phase-3 trials would be carried out on a larger population of nearly 45000 persons across all sites.
Truth is that SRMIST would need around 1500 volunteers above the age of 18. Dr. Satyajit Mohapatra later hinted that discussions and preparations for the next phase are going on and how the phase-3 trials would start in 2 weeks of time.
It is worthy to mention that DCGI or Drugs Controller General of India would be administering vaccine dosage to the volunteers. Point is that once when the data for the first 2 phases have been submitted that DCGI would give approval for the third phase of trials.
The second dose of vaccine under phase-2 trials is being administered to the volunteers and so far the volunteers in the first 2 phases have not reported any adverse effects. On 23rd July, phase-1 began and it involved testing the vaccine`s safety. On 8th September, phase=2 began and it looked for the immunogenicity or ability of the vaccine to provoke an immune response.
