‘Making a vaccine is no cakewalk where you decide one day, and come out with it in a few weeks’s time.’
More than Bharat Biotech, the Indian company developing India’s first indigenous COVID-19 vaccine, Covaxin, in collaboration with the Indian Council for Medical Research and the National Institute of Virology, it is a letter shot off by the ICMR director-general that is making news right now.
The letter written by the ICMR DG said, ‘It is envisaged to launch the vaccine for public health use latest by 15th August 2020 after completion of all clinical trials.’
ICMR also asked the 12 institutes chosen for clinical trials to fast track them as it was considered one of the top priority projects being monitored at the top-most level of the government.
The ICMR DG letter went on to say, ‘Kindly note non-compliance will be viewed very seriously. Therefore, you are advised to treat the project on highest priority and meet the given timelines without any lapse.’
Though ICMR later offered a feeble explanation that the letter was written to cut red tape, ordering the institutes to fast-track the clinical trial made headlines worldwide, and scientists within India and outside questioned such an order.
Dr Soumya Swaminathan, chief scientist at WHO, said a vaccine needs at least 8 to 9 months for clinical trials to conclude.
“We should not give false hope to people or the government saying that we will have a vaccine in one month’s time or five months’ time,”Dr Rakesh Mishra, director, Centre for Cellular and Molecular Biology, tells Rediff.com’s Shobha Warrier. The first of a two-part interview:
Do you think the ICMR DG’s letter has affected the credibility of Indian science?
You should not take the letter beyond its spirit. You should not give too much of importance. It was addressed to the hospitals to expedite the trial.
I agree that it is absolutely absurd to say that in five weeks’ time, the vaccine should be delivered for which the trial has not even started. There is no explanation why ICMR did it.&
One thing is, it is just not possible.
But I don’t agree that this undermines the credibility of Indian science because many of us immediately gave statements, and the Science Academy also responded in no time.
This was a mistake by ICMR, which I assume they did to put pressure on the internal system, so that people took the trial seriously.
At a critical time like this, do you need to put pressure?
By pressure, I mean perhaps at ICMR, they feel that those involved may delay the process. I agree that there are many ways to put pressure on those doing the work, but writing a letter to fast-track the trial is unprofessional.
The fact is, you can’t do something which requires X number of days in half X number of days.
Now they have corrected what they have done, and said that there would not be any short cuts.
It would take not five weeks to develop a vaccine; normally it takes five years. Yes, it will be wonderful if we can come out with a vaccine in five months!
The strong reaction from the Indian Academy of Sciences was that a vaccine by August 15 was ‘unfeasible and unrealistic’.
Yes. Even before that reaction itself, many of us scientists have said that such a deadline is not possible, and it cannot be done.
Have you seen such an accelerated development pathway for any vaccine anywhere in the world?
There are certain things you cannot do beyond a time limit. It takes 2-3 weeks’ time to know if there is a response to a vaccine or not. That is because that is how our immune system works.
The Stage 1 trial is to see whether the vaccine is harmful or not, that is, whether it is safe. You can call it a safety trial. You cannot say whether it is safe or not in 2 or 3 days’ time.
You have to wait for a certain number of days for the body to react. So, you wait for the stipulated time, look at the reaction, collect the data, analyse it and then go to the agency with the result.
If you see that those who took the vaccine are safe, you can move to Stage 2.
In Stage 2 also, you have to go through the same exercise, and wait for 2-3 weeks to see whether there is any immune response or not.