Both local candidates for coronavirus (Covid-19) vaccines have completed Phase 1 human trials and their developers have recruited subjects for the Phase 2 trials, the director general of the Indian Medical Research Council (ICMR) said on Tuesday. Dr Balram Bhargava.
Phase 2/3 human trials on the Oxford-AstraZeneca vaccine candidate from the Serum Institute of India (SII) were also taking place in the country until last week, when they had to be stopped after a UK trial participant conducted an unexplained side reaction.
“… Zydus Cadila’s has completed the Phase 1 human trials and the Phase 2 recruitments are complete. For this three doses with 28 days difference will be given. For the Bharat Biotech vaccine candidate as well, the Phase 1 test is done, as well as the recruitment of test participants for the Phase 2. For this test, two doses must be given. The results are being analyzed, “Bhargava told a news conference.
The Auditor General of India (DCGI) asked SII to suspend new recruitments and submit permission from data security monitoring boards in both the UK and India, and to obtain a permit from the Central Drug Regulator for resume evidence.
Dr Bhargava said: “The Serum Institute of India (SII) has completed the Phase II trials for which 100 participants were given the vaccine dose. There is a seven-day break and after that they plan to start Phase 3 trials with around 1,500 participants on 14 sites. ”
Another candidate for the Covid-19 vaccine, which is being discussed for testing in India, is a Russian-developed one called Sputnik V.
“Russia has just started the Phase 3 trials for this vaccine,” Bhargava said, adding that a high-level Indian government committee, the Russian government and diplomats were engaged in talks to conduct trials in India.
“The first safety and efficacy study of this candidate for the vaccine in 76 patients was published in The Lancet. For the trials to start in India the necessary regulatory permits will be required, “Dr Bhargava said.
No specific medicine or vaccine for Covid-19 is yet available worldwide.
The national government task force and the joint monitoring team are also reviewing the benefits of plasma therapy for Covid-19 patients.
“Plasma therapy has been in use for more than 100 years now for various infections, whether it benefits or not, it needs to be investigated. Requires random control evidence. According to the ICMR, a study was done with 464 patients in 39 hospitals in 25 districts in 14 states, and although it did not show much benefit, the data are still in the pre-print stages and will be further reviewed and a considerable picture will take, ”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 had not reached the peak of the disease of the kind that has been seen in western countries due to measures the government took long ago to contain the outbreak.
“In India we have been able to spread the curve because of very effective measures, so we did not have a peak in that sense,” he added.
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