The Data and Safety Monitoring Board (DSMB) has cleared its way for Bharat Biotech’s Covaxin vaccine safety on humans during a recent review on the data of first phase of clinical trials conducted on 50 patients across various hospitals in India.
Initially the ICMR has given nod for conducting clinical trials on 375 people across 12 clinical trial centres set up by the ICMR in leading hospitals across various states in the country. Of them 60 people have been chosen as subjects from Telangana, wherein the clinical trials for the first dose of Covaxin was being taken up under the supervision of expert doctors at Nizam Institute of Medical Sciences (NIMS) last week on July 20.
After verifying the data submitted by various clinical trial centres to DSMB, it is learnt that the safety monitoring board has allowed the clinical trial centres to continue recruiting participants for further trail after it found that the data of the first 50 participants administered with the Covaxin had shown no adverse health issues with the participating subjects.
“We are happy that the DSMB has cleared its way for the second level of clinical trials for the Covaxin. The first level of clinical trial where a low dose of vaccine was administered to the participating subjects has proved safe on humans. Now, the second level of clinical trial will be for a higher dose of the vaccine. If this trail clears, then the pathway for large scale administration of vaccine will be cleared,” informed Dr. Savita Verma, Principal Investigator for the trial at Pandit Bhagawat Dayal Sharma Post Graduate Institute of Medical Sciences (PGIMS) in Rohtak.
Healthcare experts observed that whenever a drug or vaccine is to be tested for the first time on humans, it is initially administered in low doses and in a small number of individuals because it is only to check if the vaccine is safe enough to proceed further.
From NIMS, the initial test was conducted on 5 persons out of 60 selected subjects, while from PGIMS as many as 20 persons were selected for the initial clinical trials. In the next phase, the Covaxin will be tested for higher doses and will check if the vaccine is causing any allergic reactions on the subjects being tested.
With the DSMB clearing the way for the second level of clinical trials which began from July 15, the subjects participating in the second level are expected to receive the second dose on July 31.
The Data and Safety Monitoring Board (DSMB), also called data monitoring committee (DMC), is an expert committee, independent of the sponsor, chartered for one or more clinical trials.
The mandate of the DSMB is to review on a regular basis the accumulating data from the clinical trial to ensure the continuing safety of current participants and those yet to be enrolled. DSMB has the additional responsibilities to advise the sponsor regarding the continuing validity and scientific merit of the trial.
In India DSMB will work under Ministry of Health under the advice of Central Drug Standards Control Organization (CDSCO).
Source : 1