At least three of the hospitals – AIIMS in Delhi, SRM Hospital and Research Centre in Kancheepuram and King George Hospital in Vishakhapatnam —chosen to conduct clinical trials of Covaxine, are learnt to be still awaiting ethics committee approvals to begin enrolling participants for the study. Other hospitals are awaiting site initiation visits and clearances to ensure their facilities are ready to conduct these trials.
Depending on the hospital, enrollment of participants is expected to begin between this week and the next, but the testing can only start once they receive stock of the vaccine. This will happen once Bharat Biotech receives a clearance from the Central Drugs Laboratory in Kasauli to use its vaccines in the trials.
Meanwhile, PGIMS, Rohtak, a site chose for conducting trials said that it has started the process of short-listing volunteers for trial. Once the site initiation letter is received, they will begin collecting blood and urine samples of each prospective participant and send it to a central laboratory to assess whether the candidate is eligible for trial.
The delivery of the vaccine will depend on biosafety and bio sterility tests conducted at CDL Kasauli, said a senior government official. For this specific vaccine, the tests to check whether it is safe to inject in participants will take 14 days as per Indian and international protocols.
The Clinical Trials Registry of India on Monday showed that the date of first enrollment for the vaccine is now set at July 13, while the phase I and II trials are estimated to take one year and three months. According to the protocol on the registry, the first phase alone will at least take a month, after which interim data will have to be submitted to the Drug Controller General of India before proceeding to the next stage.
Some investigators have said they are not under pressure to rush the trials for the sake of a faster launch date. Last week, the Indian Council of Medical Research (ICMR) had faced flak from the scientific community for seeking completion of “all” trials by August 15, adding that it was envisaged to launch the vaccine for public health use no later than that date. However, ICMR had later clarified that it was only seeking to fast-track clearances and cut red-tapism.