AstraZeneca event shows Covid vaccine can’t be developed in haste: Kiran Mazumdar Shaw

We have to wait and that is why people are saying that you should not expect a vaccine by the end of the year because it is too short a time, says Chairperson & MD, Biocon.

Help us understand what could possibly be the factors that have made AstraZeneca trials grind to a halt since it seemed to be one of the front-runner vaccines?
This is the reality check that everyone has been talking about in the medical and scientific world. People need to understand that vaccine trials have to be carefully conducted and every serious adverse has to be investigated while the trial is going on because this is actually being inoculated on healthy people. So, that is why we have to be very careful. These are not people who have got coronavirus already. These are people whom we want to immunise against coronavirus and so it is very important to do the trial properly and safely. The main data points that people look for in any trial, especially vaccine trials, is safety and efficacy of data and it is about safety first.

This is not unusual because this happens in every trial and that is why it takes so long. When you try to shrink timelines into the kind of timelines we are talking about today, safety risks arise and that shows you how difficult it is to develop vaccines and this happens in the case of any drug where any patient who develops serious adverse event, will have to investigated and therefore such trials are always put on hold. But hopefully, it is something that will be investigated and resolved very fast and then the trial will resume.


But this actually is an important event that people have to take note of. It is not easy to just rapidly develop vaccines and lots of things have to be investigated.

Do you think the news which came from AstraZeneca last night is a polite reminder that despite whatever we may try to do in order to really fast track the vaccine development, vaccines cannot be fast tracked? It is a process which will take its own time?
Well that is what the pharmaceutical and the medical world has been talking about over the last few months. But people are anxious, inpatient and obviously everyone wants a vaccine but this is a reminder as to why you cannot compress timelines and what are the dangers of compressing timelines because if you disregard such events and continue to enrol patients, you might suddenly find a larger number of patients having the same problem and that is not good for the vaccine. In fact, the vaccine cannot be approved when you see too many adverse events which might not happen in the first month or the second month and you might even get it after a few months. That is why you have to wait and that is why people are saying that you should not expect a vaccine by the end of the year because it is too short a time.

As one of the leading figures in the pharma world said, you cannot compress one year data into three months because this is about human life, this is about the human body and you have to wait for certain read-outs.

You have been maintaining that we should not expect a vaccine before the year end. Are we looking at March or April or even May before it will be widely available?
It was always discussed that even if you get an expedited vaccine, it would only have emergency use authorisation for a limited use. The actual safer vaccine that would have been looked at for approval would be in the March, April timeline.