The two indigenous vaccine candidates against the coronavirus disease (Covid-19) have completed Phase 1 human trials, and their developers have recruited subjects for Phase 2 trials, Indian Council of Medical Research (ICMR) director general Dr Balram Bhargava said on Tuesday.
Phase 2/3 human trials on the Oxford-AstraZeneca vaccine candidate by the Serum Institute of India (SII) were also underway in the country until last week, when they had to be paused after a trial participant in the UK developed an unexplained adverse reaction.
“…Zydus Cadila’s has completed Phase 1 human trials, and Phase 2 recruitments have been completed. For this three doses are to be given 28 days apart. For Bharat Biotech’s vaccine candidate also, the Phase 1 trial is done, and so is recruitment of trial participants for Phase 2. For this trial, two doses are to be given. Results are being analysed,” Bhargava said at a media briefing.
The Drugs Controller General of India (DCGI) asked SII to suspend new recruitments, and submit clearances from the data safety monitoring boards of both the UK and India, and obtain a clearance from the central drugs regulator to restart the trials.
Dr Bhargava said: “Serum Institute of India (SII) has completed Phase II trials, for which 100 participants have been given the vaccine dose. There’s a seven-day pause and after that they plan to begin Phase 3 trials with about 1,500 participants across 14 sites.”
Another Covid-19 vaccine candidate, for which talks are on for trials to be conducted in India, is the one developed by Russia called Sputnik V.
“Russia has just started Phase 3 trials for this vaccine,” said Bhargava, adding that a high-level Indian government committee, the Russian government and diplomats were engaged in talks on conducting the trials in India.
“The first study of safety and efficacy of this vaccine candidate in 76 patients was published in The Lancet. For trials to start in India necessary regulatory clearances would be required,” said Dr Bhargava.
No Covid-19-specific drug or vaccine is available yet globally.
The government’s national task force and joint monitoring group is also reviewing the benefits of plasma therapy for Covid-19 patients.
“Plasma therapy is in use for more than 100 years now for different infections, whether it benefits or not needs to be investigated. It requires randomized control trials. Under ICMR, a study was done with 464 patients in 39 hospitals across 25 districts in 14 states, and even though it didn’t show much benefit, the data is still in pre-print stages and will be reviewed further and a considered view will be taken,” said Dr Bhargava.
Plasma therapy uses the blood of a recovered patient to create antibodies in infected individuals.
The ICMR director general also said India hadn’t attained the peak of the disease of the kind that has been seen in western countries because of the measures that the government took well in advance to contain the outbreak.
“In India we have been able to distribute the curve because of the very effective measures, so we did not have a peak in that sense,” he added.