One thousand vials of Covaxin, the Covid-19 vaccine developed by Indian pharmaceutical company Bharat Biotech, arrived at the state vaccine store at Anand Rao Circle here on Wednesday. Each vial contains 20 doses.
SpiceJet’s freighter flight SG 7555 took off from Hyderabad at 8.50 am, carrying three boxes weighing 90 kg of Covaxin, and landed in Bengaluru at 10.23 am.
An official in the immunisation wing of the Karnataka Health Department confirmed to DH that they had received 20,000 doses of the vaccine.
Unlike Covishield, manufactured by the Serum Institute of India, Covaxin has been approved under the ‘clinical trial’ mode. During the first two months of the rollout, Bharat Biotech has to notify drug regulators every fortnight the adverse effects of the vaccine.
The 20,000 doses that arrived on Wednesday are among the 40,000 doses of Covaxin that have been allotted to Karnataka, according to Dr C N Manjunath, state nodal officer for Covid-19 testing and a member of the Technical Advisory Committee.
Covaxin hasn’t been without controversies and it’s still in Phase 3 trial (the period when the vaccine is administered to thousands of people to test its efficacy).
In Karnataka, healthcare workers will be the first recipients of Covaxin.
Dr Manjunath said the participants’ consent would definitely be taken as the vaccine was being rolled out in the ‘clinical trial’ mode as per the approval given by the Drugs Controller General of India (DCGI) and because all healthcare workers being vaccinated with Covaxin were in essence trial participants.
“If no consent is taken, it will be like doing a trial under the shadow of the vaccination programme,” he added.
The union health secretary clarified recently that healthcare workers would not get to choose between Covishield and Covaxin.
An expert who would be quoted said that if Bharat Biotech was mandated to report the adverse effects of Covaxin to the DCGI every two weeks, then the healthcare workers receiving the vaccine should be monitored. “If they have to be monitored, they should be informed which vaccine they are getting,” he added. “Choice and consent are different.”
The expert further said that if Covaxin was being rolled out alongside Covishield from January 16 onwards in a ‘clinical trial’ mode, it wasn’t clear who would be the principal investigator and who all would be part of the Data Safety Monitoring Board and the Ethics Committee.