India’s Covaxin Vaccine By 15 August: Only If ICMR Ignores Science

Yeh Jo India Hai Na, for a feel-good moment on 15 August, it shouldn’t put out a poorly tested COVID-19 vaccine.

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Yeh Jo India Hai Na… It needs a COVID-19 vaccine really urgently. With over 19,000 dead, nearly 2.5 lakh active cases, adding 20,000 cases everyday. Yes, a vaccine would save a lot of lives, would get our economy back on track.

But does that mean we can simply make it happen by 15 August. The answer, unfortunately, is no. Will you and I be able to have a dose of Covaxin by 15 August? No. Is the Indian Council of Medical Research or ICMR’s plan to launch India's 'fully indigenous' corona vaccine on 15 August just wishful thinking? Unfortunately, yes.

Click on the player below for the podcast.

Pushing Out a Vaccine in a Hurry is Unscientific, Irresponsible

Could India be the first country to develop a corona vaccine? Maybe, maybe not, but, certainly not by 15 August. And why am I emphasising this? Because to push out a vaccine in such a hurry would be highly unscientific, highly irresponsible and it could cost lives instead of saving any.

Look beyond India, at the US, Brazil, Russia and Europe – the world does need a vaccine desperately, with over half a million dead and four-and-a-half million active cases to cure.

And scientists are racing to do that, some vaccines are even in initial stages of clinical trials. But nobody, nobody has any chance of having a vaccine, tried, tested and ready by August, not even September, or even October.

The Covaxin

It was only on 29 June that we first heard of this potential indigenous vaccine 'Covaxin', being developed by Bharat Biotech, working with ICMR and the National Institute of Virology in Pune. It had shown promising results in animal trials and now had permission for phase 1 and 2 human trials. But so far, even the pre-clinical trial data for Covaxin has not been shared by Bharat Biotech or ICMR.

So, is it possible for this vaccine, or for any vaccine, to go from phase 1 of human trials to hitting the market in 45 days?

Here are some expert reactions:

India’s Covaxin Vaccine By 15 August: Only If ICMR Ignores Science
(Graphics: The Quint)
India’s Covaxin Vaccine By 15 August: Only If ICMR Ignores Science
(Graphics: The Quint)
India’s Covaxin Vaccine By 15 August: Only If ICMR Ignores Science
(Graphics: The Quint)
India’s Covaxin Vaccine By 15 August: Only If ICMR Ignores Science
(Graphics: The Quint)

ICMR’s ‘Warning’ to 12 Hospitals

But ICMR worryingly rejects this scepticism of the medical and scientific community. In a fresh 4 July press release, ICMR says, while feedback is welcome, do not second guess our professionalism or adherence to the highest scientific rigour.

Excerpt from ICMR’s 4 July press release.
Excerpt from ICMR’s 4 July press release.
(Graphics: The Quint)

Wow, pretty aggressive. And in that context, let’s look at the letter that ICMR has written to the 12 hospitals that are to carry out the Covaxin clinical trials. While laying down 15 August as the vaccine launch date, the letter also gives a clear warning:

Excerpt from ICMR’s letter to 12 hospitals.
Excerpt from ICMR’s letter to 12 hospitals.
(Graphics: The Quint)

Bharat Biotech and ICMR Not on the Same Page

Now, in an interview to The New Indian Express on 2 July, Dr Krishna Ella, chairperson of Bharat Biotech, said the vaccine won’t be available before 2021. So, clearly Bharat Biotech and ICMR are not on the same page.

So, why is ICMR in this big rush, throwing all scientific caution to the wind. A clue may lie in this other line from the ICMR letter – that describes Covaxin as a “top priority project being monitored at the topmost level of the government.”

India’s Covaxin Vaccine By 15 August: Only If ICMR Ignores Science
(Graphics: The Quint)
Is ICMR under pressure from a government that may be looking for some good news to share with the public on 15 August? But can the government ignore medical science, just for one feel-good moment on 15 August? No, it cannot.

Covaxin Has Potential

Now, one is not saying that Covaxin won’t work. In fact, Dr Jacob John says Covaxin’s pre-clinical trials, done successfully on animals, show that Covaxin has potential. He believes that given the urgency, phase 1 and 2 of the clinical trials could be run together. But he says that itself would take up till August.

After that, phase 3 is a crucial phase involving hundreds, even thousands of volunteers to confirm the efficacy and safety of the vaccine in large populations. This alone will take a few months. You cannot push medical science any faster. A vaccine has been known to have a reaction worse than disease itself. Dr John points out that Dengvaxia, a Dengue fever vaccine had to be withdrawn for this very reason.

It is true that for COVID-19 vaccines, the world over, research has been fast-tracked. Countries and companies and scientists are collaborating as never before. There are over a 140 vaccine candidates in various stages of research and trials. But, even then the most optimistic scenario for a proper vaccine is the beginning of 2021.

Yeh Jo India Hai Na… if it is the first to produce a vaccine to fight COVID-19, that would truly be awesome. But if we do it by ignoring medical science, well then, our vaccine will be as effective as Mr Athavale’s ‘Go Corona Go’ vaccine!

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