Covid-19 vaccine: Covaxin undergoes safety, quality checks before trials
Enrollment of participants in the trials is expected to begin over the next two weeks once designated hospitals receive vaccine stocks
Samples of Bharat Biotech’s Covaxin - the indigenous vaccine against Covid-19 - are undergoing quality and safety checks at a government facility as 12 medical institutions chosen to conduct clinical trials prepare to enrol participants, The Indian Express has reported.
The tests began last Friday and are expected to be completed by the end of next week. The quality and safety checks cannot be rushed as they are expected to ensure the vaccines are safe to use in humans, the report quoted senior officials as saying.
According to the report, some of the hospitals chosen for clinical trials are waiting for ethics committee approvals to begin enrolling participants for the study. Others are awaiting site visits and clearances stating that their facilities are ready to conduct these trials, the report said.
Enrollment of participants in the clinical trials is expected to begin over the next two weeks, but the testing can only start after the hospitals receive stocks of the vaccine. This will happen once Bharat Biotech receives a clearance from the Central Drugs Laboratory (CDL) in Kasauli to use its vaccines in the trials, The Indian Express said.
Once it receives a clearance from CDL, Bharat Biotech may take a few days to ship stocks of the cavvine from its facility to the clinical trial sites. The Indian Express said that the first phase of the study was thus expected to begin in two weeks.
The report quoted an investigator from one of the hospitals seeking approval for the trials from the ethics committee as saying that this was a time-consuming and stringent process.
Read the full report in The Indian Express