Vaccines are safe but we don’t know how effective they are as we don’t have data

FOR THE RECORD

Vaccines are safe but we don’t know how effective they are as we don’t have data

As the much-awaited Covid vaccine rollout happens in the country, Rema Nagarajan speaks to Shahid Jameel, a top virologist and director of the Trivedi School of Biosciences at Ashoka University, about the notion of ‘desi’ vaccines and the need for transparency when it comes to trial data

Some health workers have expressed vaccine hesitancy and said they feel like guinea pigs. How justified are these fears?

I partly agree and partly disagree with that notion that they are being made guinea pigs. Let’s say that we are fairly confident that these vaccines are safe and frontline workers are not being given a substance that is going to be harmful to them. But whether the substance actually helps achieve what it is trying to achieve, that’s still clouded in mystery because we don’t have the data. It’s not that I’m making this up. Bharat Biotech has said that their phase 3 is not over yet. They are on record as saying that. Also, in the case of Serum Institute, where is the data from the efficacy trials in India? It’s not there. Serum Institute’s vaccine has efficacy data from Brazil and the UK. And then you realise that they are combining data from Brazil and the UK and arriving at a 70% efficacy when the dosing was different in those two trials. They keep saying that it’s statistically possible. I’m not a biostatistician. But to my mind if one trial uses half dose-full dose and the other trial uses two full doses, I cannot combine data from those two trials.

So there is insufficient data in the public domain right now about the vaccines that are going to be used in India?

The publications of phase 1 and 2 trials are there. But phase 3, the trial isn’t even over yet. Nobody has seen the data except the subject experts committee and nobody knows who they are. So a lot of opacity exists. Data should be available to those who know about it and people who don’t have a direct conflict of interest should evaluate it. That’s how science works. We are forgetting that vaccines are a product of science. They are not a product of religion that we are going on belief. Science looks at data and evidence.

But should we have started before the efficacy data comes out?

Let me first say that I have no interest in either Covishield (by Serum Institute) or Covaxin (by Bharat Biotech). They are both privately owned companies, and I don’t own shares in either. I would say that there is at least some evidence of efficacy for Covishield so we could have just started with it. And then let data come in for Covaxin and then deploy Covaxin. That could have evoked far more trust in the system. Krishna (Ella, Bharat Biotech CMD) is a friend, someone I have known for 30 years, but I am looking at science. I’m not willing to let my personal relationship cloud my professional judgement.

In the Covishield vaccine insert, they are saying 53% efficacy if given less than six weeks apart, 79% efficacious if given after 12 weeks. But India is talking about giving it within four weeks. Would that work?

In India, the trial that was done was four weeks apart. So India is right in choosing that, but where is the data for it? How do we know whether it’s 50% or 60% or 70%? We don’t know.

What about the notion that vaccines are being developed in a rush?

Yes, there is that perception, but I really don’t think corners have been cut. The protocol has been followed. What has been done is that sometimes phases have run in parallel and regulators have looked at data very expeditiously and given their views on it, which sometimes used to take a long time. Of course what we haven’t done is waited six months to figure out whether there will be a safety issue after six months. We can’t afford to do that. We are in a pandemic. If you want to quell a pandemic with a vaccine, you have to give it now. So yeah, there is always going to be this issue. But I feel that it’s important to tell people exactly what it is instead of using all kinds of smokescreens.

There seems to be the perception that there is an extra push for an Indian vaccine.

What is an Indian vaccine? A vaccine is a product of science and science is global. So I don’t subscribe to this view that something is an Indian vaccine. The Indian vaccine also includes a US adjuvant, without which the vaccine may not work very well. I think it’s very misleading to label things like that. I mean the Serum Institute vaccine is also an Indian vaccine.

Why would asking questions about the vaccine be called anti-national?

I’m possibly one of those perceived anti-nationals. So how can I answer that? It’s people who are calling us anti-nationals who should possibly answer that question. I would only say that we are like canaries in a coal mine. And if you kill your canaries, your coal mine will someday explode without warning.

As a virologist, what is your assessment of the bird flu outbreak?

Bird flu keeps happening in winters. Actually between 2006 and 2015, India alone had 25 separate episodes of bird flu across 15 states. So it’s not something that has just dropped out of the sky. I think we are being extremely sensitive these days because of Covid. So anything adds to the level of our anxiety. But the thing with bird flu virus is that it infects humans very, very poorly. So, we don’t really have to worry about it unless it’s people who come into very close contact with infected birds. They have to be careful. And it is treatable, there are drugs for it.