India's COVID-19 vaccine candidates will go through a rigorous evaluation process that will not be compromised, the government's Principal Scientific Advisor K VijayRaghavan said on Friday, indicating that the ICMR-Bharat Biotech vaccine is unlikely to be out by August 15.
Phase 1 of the human trial of any vaccine usually takes 28 days and that is followed by two other phases, VijayRaghavan said while addressing a webinar at the Vivekananda International Foundation.
India's drug regulator has given the go-ahead for trials for two vaccine candidates -- Bharat Biotech vaccine and the Zydus Cadila vaccine.
"So, the Bharat Biotech vaccine or the Zydus Cadila vaccine will go through a rigorous evaluation process which will not be compromised, as ICMR clarified," VijayRaghavan said.
Aiming to launch an indigenous COVID-19 vaccine by August 15, the Indian Council of Medical Research has written to select medical institutions and hospitals to fast-track clinical trial approvals for the vaccine candidate COVAXIN being developed in collaboration with Bharat Biotech.
Responding to a question on ICMR's letter, VijayRaghvan said, "Today is 10th of the July and let's say the phase 1 trial starts today. And they start at all the 12 sites simultaneously...(which is) unlikely.
"Let us assume that they start together. Phase 1 trial involves an injection, then another injection after seven days and then an examination after 14 days and then looking at the results of that before deciding, so after 28 days," he said.
After Phase 1, there are two other phases, he stressed.
"So the timeline for a vaccine, if we look at the global ones, will go into phase 3 trials in several months after the Phase 1 trial," he said.
Experts have cautioned against rushing into the process for developing a COVID-19 vaccine and stressed that fast-tracking vaccine development for diseases of pandemic potential is not in accordance with globally accepted norms.
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