Applicants for the Indian COVID-19 vaccine will undergo a rigorous evaluation process, said Vijay Raghvan.
New Delhi:
India’s COVID-19 vaccine candidate will go through a rigorous evaluation process that will not be compromised, chief government science advisor K Vijay Raghavan said on Friday, saying the ICMR-Bharat Biotech vaccine should not come out. here on August 15.
Phase 1 of the human trial of any vaccine generally takes 28 days and is followed by two more phases, said Vijay Raghavan during a speech on a webinar at the Vivekananda International Foundation.
The Indian drug regulator has given the green light to the trials of two vaccine candidates – the Bharat Biotech vaccine and the Zydus Cadila vaccine.
“Thus, the Bharat Biotech vaccine or the Zydus Cadila vaccine will go through a rigorous evaluation process which will not be compromised, as the ICMR has specified,” said Vijay Raghavan.
Even if the vaccine is available today, it will take a year or two to make it available to everyone, with priority given to the vulnerable, he said.
With the aim of launching a native COVID-19 vaccine by August 15, the Indian Council for Medical Research has written to select medical facilities and hospitals to expedite the approval of clinical trials for the candidate vaccine COVAXIN developed in collaboration with Bharat Biotech.
Responding to a question about the ICMR letter, Vijay Raghvan said: “Today is July 10 and let’s say that the phase 1 trial starts today. And they start simultaneously on all 12 sites … (this which is unlikely).
“Suppose they start together. The phase 1 trial involves one injection, then another injection after seven days, then a review after 14 days, then looking at the results before deciding, so after 28 days “
After phase 1, there are two other phases, he said.
“So the schedule for a vaccine, if we look at global vaccines, will enter phase 3 trials in several months after the phase 1 trial.”
Asked how the process can be speeded up, Vijay Raghavan said that phases 1 and 2 can be combined and carried out simultaneously. Both phases focus on safety and immunogenicity in humans. Phase 3 also requires a very large number of people over a very long period, but this can also be reduced.
“All of this can take a period of five to ten years which can be reduced to a period of around 12 to 15 months. It is an extremely expensive process since massive parallel processing is necessary,” he said.
Vijay Raghavan added that investing in manufacturing, storage and creating a supply chain can also be done simultaneously.
Experts warned of any haste in the process of developing a COVID-19 vaccine and stressed that the accelerated development of vaccines against diseases with pandemic potential does not meet globally accepted standards.
In response to a question about a realistic timetable for the availability of vaccines in India, the chief scientific adviser said: “If there is a vaccine today that can be used … to develop it for human purposes, it takes a while to develop it (production).
“Let’s say you’ve already accelerated it. If you have a few million doses available for all over the world. Global organizations will decide priorities. They will give it to the most vulnerable and then they will give it to others. So these types of vaccines will take a year to deploy, so availability will span a year or two. “
Until then, five things need to be followed diligently: face masks; hygiene, hand washing and so on; social distancing, contact seeking; tests and isolation.
“If we do that, we can not only smooth the curve, but we can beat it. It is very difficult to do in real life with the economic opening, but we have to focus on that and it should be our job. “, did he declare. .
