Dr Shahid Jameel, at present the director of the Trivedi School of Biosciences at Ashoka University, is a well-known virologist. A recipient of the prestigious Shanti Swarup Bhatnagar Prize for science and technology, Dr Jameel talks to Outlook on various aspects of the vaccine development process for Covid-19. Excerpts:
Q: Some experts have advised caution and opposed granting permission to vaccines under emergency authorisation use. What’s your take?
A: I am also not in favour of compromising on safety and effectiveness but having come so far, we cannot also stop everything. Let the trial be finished and data be looked at. Approval should be given on the basis of the data. There is no reason to jump the gun now.
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However, I don’t agree with people who say that we must take a pause. How long will we take a pause? No one tells you that. It doesn’t make sense to develop a vaccine with this speed and then say that now I am going to take a pause.
Q: So how do you look at the Drug Controller General of India’s (DGCI) recent decision to refuse approval to two vaccines companies – Serum Institute of India and Bharat Biotech?
A: I think the DCGI's expert committee has done the right thing by asking these companies to supply more data to arrive at the decision. Both Bharat Biotech and SII are doing Phase III trial and they have not reached the stage where efficacy can be calculated. So, let that happen. Once all the volunteers are vaccinated with the required two doses then we should wait and see how many people are getting infected. That’s how you calculate efficacy. In the meantime, you will also assess safety.
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Q: Ideally when should companies apply for emergency use authorisation?
A: In the US FDA system, a company can apply for EUA two months after the final dose has given to the volunteers. In the European Medicine Agency, it is 70 days after the last dose. There is a scientific reason for keeping this gap. Most of the adverse effect is seen during the first six weeks of the immunization.
In fact, the majority of them, including the acute ones, will be seen within a week or so. Within the first six weeks, longer-term effect can also be seen.
Q: So, have these two vaccines completed the mandatory trial time period for EUA permission?
A: Both of these vaccines have not even reached that stage. They have not even finished vaccinating everyone in the trial with two doses. What’s the tearing hurry in giving approval? The DCGI has done the right thing by telling them to come back with more data.
My understanding is that everyone, who is supposed to be given the second dose, hasn’t received it and even the trial is not completed let alone the waiting period. So where is the question of the approval?
Q: Now when both infection and mortality rate are going down, shouldn’t we take a more cautious approach by spending more time with the trial?
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A: I am also saying not to compromise with safety and efficacy but what does it mean by a cautious approach? What do you want to do? Nobody tells you that.
You have to understand that nobody is saying vaccinate everyone in India. That’s not possible. The government has already come out with a very clear plan on how they will go about vaccinating.
The plan is to vaccinate one crore health care workers, two crore frontline workers and 27 crore elderly and people with co-morbidities. The government has defined those who are above 50 as the elderly. Epidemiological results in India shows that 80 per cent mortality in India is above 50. So it is a good plan. It is voluntary so the government is not forcing anyone to take the vaccine.
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Q: When people are developing herd immunity and natural protection from the virus naturally, do you think we still need to spend so much on the vaccine?
A: I don’t subscribe to that view. I think we have the capacity to develop a good and effective vaccine. We must develop them and we deploy them. It is nonsense to say that we should wait around and let people get infected. I don’t subscribe to views that those who have to die they will die and those who survive will survive. Then you are not living in the 21st century but you are living in the Middle Ages.
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Q: Clinical trials of repurposed drugs like Remdesivir showed encouraging results on patients and they were authorised for treatment. Now, the WHO trial, conducted post-authorization, said that they didn’t work. Patients spent crores of rupees on them. Will it not happen with vaccines?
A: There is a very basic difference between drugs and vaccine. Drugs are given to people who are ill but vaccine are given to people who are healthy. That’s a very basic difference you must understand.
When Remdesivir and others were tried, they were tried in a do-or-die situation. What do you do when someone is sick and you think that there may be a 5 per cent or 10 per cent chance that a drug might work on them. Would you not try? Why not?
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Hindsight is always twenty-twenty. You can now say why did we try if it didn’t work? But that’s not the right question to ask.
When you start working on a drug and vaccine you don’t know what will work or what will not work. Science is a step-wise process through which you have to arrive at a conclusion. Some things work according to a plan, many don’t. That’s simply the process of science.
Q: When the infectivity of the virus is so unpredictable, don’t you think it will be a challenge in arriving at a right efficacy percentage?
A: This virus is no more unpredictable than any other virus. We are saying it unpredictable because we don’t know everything about it. However, on the basis of the early positive results of four or five vaccines, I can say that almost all the 200-odd vaccines, which are at the various stages of progress, will work.
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Q: But how can you say that?
A: All the vaccines are based on the spike protein of the virus. Those vaccines which have shown high efficacy, they have used the same spike protein.
You know different vaccine only have different ways of delivering the spike gene into the body. Otherwise, the basic constitution of every vaccine is the same. It is just a different way of delivering it.
Q: Why haven’t we able to invent a vaccine for the HIV virus in the past several decades?
A: Let me explain. The first recombinant human vaccine that came in the mid-1980s that was for hepatitis B virus.
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Scientists took the gene coding of one of the virus proteins and engineered it into yeast. The yeast produced the protein. The scientists purified this protein and injected in the body. This worked and provided protection against the virus.
That was the first recombinant vaccine which established the principle that you can take an isolated viral protein and that will give a protective response.
When HIV was established as a cause for AIDS, the same approach was applied to HIV but it didn’t work. We are actually very lucky that this vaccine has worked. It was equally plausible that it would not have worked. Then the same people, who are saying take a pause, would be jumping up and down and saying why scientists haven’t produced the vaccine.
