The Great Indian Vaccine Hoax?

By Ashwin Tombat
05 July 2020 11:18 IST

 

India will have the world’s first vaccine against Covid-19, by Independence Day, 15 August 2020. Or will it?

A letter from the Indian Council for Medical Research (ICMR), sent on Tuesday 2 July and leaked to the media on the same day, says it has partnered with the National Institute of Virology (NIV) and a Hyderabad-based private vaccine maker called Bharat Biotech International Ltd (BBIL) to fast track clinical trials of an indigenous Covid-19 vaccine. The letter was written to principal investigators (PIs) of the 12 hospitals selected to carry out the clinical trials.

This will be India’s first indigenous vaccine, says ICMR Director General Dr Balram Bhargava, warning that not meeting the deadline of 7 July (just five days later) of enrolment for the clinical trial could result in dire consequences: “Kindly note that non-compliance will be viewed very seriously,” the letter says. To place this in context, the letter adds that it is one of the "top priority projects which is being monitored at the top-most level of the government".

He’s very probably right. On Tuesday 30 June, just two days earlier, Prime Minister Narendra Modi ‘coincidentally’ chaired a meeting, reportedly to review India’s preparations for vaccinating its huge population against Covid-19.

The vaccine candidate, named Covaxin, was approved for Phase I and II human trials by the Drug Controller General of India (DCGI) on 29 June. The ICMR says it will release the vaccine by 15 August – in exactly 48 days – a timeline unheard of anywhere in the world. Strangely, at the time of writing, there was absolutely no information about the vaccine on the ICMR website.

“I don’t think anywhere in the world has anyone ever given a date in advance for the release of a new vaccine before a clinical trial has even begun,” says the Editor of the Indian Journal of Medical Ethics Dr Amar Jesani. “That is not how science works,” he added.

His view seems to be corroborated by the Chairperson of the Ethics Advisory Committee of the ICMR’s bioethics cell Vasantha Muthuswamy. “Even if you fast-track it, it will take a minimum of one year,” she said.

In fact, according to the government’s official Clinical Trial Registry, the expected duration of this very trial is recorded as being one year and three months.

Phase 1 of a clinical trial determines its safety. Phase 2 looks at the immune responses triggered by the vaccine. But a vaccine is deemed safe for commercial release only after Phase 3, which is a much larger trial to test its efficacy, involving thousands of participants.

The documents for the Covaxin trial do not even mention Phase 3. The pre-clinical phase of vaccine development, too, does not inspire much confidence.

ICMR transferred the strain NIV had isolated to Bharat Biotech on 9 May. The DCGI approved human trials on 29 June; there were exactly 50 days in between.

Animal trials with mice usually take at least three months. This is what Bharat Biotech Chairman Dr Krishna Ella himself said in a media interview on 7 April: “It will take at least three months to do animal trials to establish safety properly.”

But in a subsequent media interview that followed the announcement on Thursday 2 July, Dr Ella had something different to say. He told the interviewer that after getting the virus strain from the NIV [on 9 May], Bharat Biotech established good manufacturing practices (GMP) protocols and developed the first set of GMP batches in 40 days, after which period the pre-clinical trials commenced.

There were exactly 50 days between receiving the virus strain from NIV and getting clearance from the DCGI for human trials. Could Bharat Biotech have conducted the animal trials, compiled its report, and got it scrutinised and approved by DCGI, all within just 10 days?

The numbers simply do not add up. Are we looking at a scam? 

Even the 12 institutions chosen to conduct the trial are a mixed bag. Two are AIIMS hospitals (Nagpur and Patna). Five others are established hospitals and/or medical colleges. The other five are a cause for deep concern.

Prakhar Hospital in Kanpur, UP, is a maternity hospital, with no research credentials. Rana Hospital in Gorakhpur, UP, is a private “multispeciality hospital”. Its website does not talk about any research experience. Gillurkar Multispeciality Hospital, Nagpur, is run by Diabetologist Dr Chandrashekhar Gillurkar. His personal website says he has “worked in about 22 trials successfully”, but gives no further details. Jeevan Rekha Hospital in Belgaum is run by Dr Suresh G Bhate and his son Dr Amit. The hospital has a Facebook page, which discloses no research experience.

Last, but not least (in that it is closest to us), is the Redkar Hospital in Dhargal, Pernem, owned by Dr Vivek Redkar and his son Dr Sagar. It was recently in the news because former Pernem MLA the late Jitendra Deshprabhu was briefly admitted there on Tuesday 21 April before he was moved to the Goa Medical College, where he unfortunately succumbed to pneumonia. Though Redkar Hospital has the phrase “Research Centre” appended to its name, its website does not list ‘research’ among its activities.

Alarmingly, four of these five private hospitals say they have already got clearances from their ethics committees. All four of them got the approval on 30 June itself, just one day after the DCGI cleared the human trials!

Enough said.

On 25 March Prime Minister Narendra Modi said that the Mahabharata battle was won in 18 days while the war against coronavirus will be won in 21 days [of the first lockdown]. He was wrong.

Right now, only the US, Brazil and Russia have more Covid-19 infections than India, and we are very likely to overtake Russia within a week. In the month of June alone, India nearly tripled its cases, from 1.98 lakh to 5.85 lakh. The last two lakh cases were added in just 12 days.

India got the lockdown wrong. We flattened the economy instead of the virus, which is now spiralling out of control. We cannot now afford to get India’s first ever indigenous vaccine wrong as well. Otherwise, quite apart from the resulting damage to human lives, India will be the laughing stock of the world.

 

NOTE 1: The ICMR ‘clarified’ on Saturday 4 July that its letter to clinical trial sites, which mentioned the date [15 August], “was meant to cut unnecessary red tape”. Its statement said: “The aim is to complete these phases at the earliest, so that population-based trials for efficacy could be initiated without delay.” But it remained silent both on the unrealistic timeline and the strong language used in its letter of 2 July.

 

NOTE 2: Dr Sagar Redkar of Redkar Hospital has sent the following letter in reply:

Respected Sir,

With reference to the news about Redkar Hospital published on 7 July 2020 ['The Great Indian Vaccine Hoax?', Goanews.com] it says: "Though Redkar Hospital has the phrase 'Research Centre' appended to its name, its website does not list ‘research’ among its activities."

Please find a list of research publications we have published and represented at various international platforms, which will clarify the doubts about the phrase 'research centre' added to the hospital name.
[This letter was accompanied by a list of two research publications on Covid-19 and five on Diabetes and Hypertension, all either published in scientific journals and/or presented at national or international seminars in the past two years - Editor].

We are proud of our achievements in the field of medical sciences and having represented Goa and the country at the highest platforms.

Possibly 'medical journalism' is not given the due importance it deserves to appreciate these kind of achievements and to be 'in the news' for the same.

But it is unfair that 'lack of information/knowledge' just on the basis of unavailability of content on the hospital website should mask the achievements and recognition of all the hard work done and the efforts we have put in.

Feel free to contact us at any time for any queries and doubts.

Thanks and regards,

Dr Sagar Redkar

Blogger's Profile

Ashwin Tombat

Ashwin Tombat has been the Editor of Gomantak Times and Herald. Worked as an Associate Editor of national magazine Gentleman in Mumbai, before shifting to Goa. Loves sailing, also participates in Marathons. Has worked as an activist in students's union and trade unions in Maharashtra. Also an artist of Street Theatre during student days.

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Previous Comments

It's all to show the greatness of an Individual.

And then on 15 th August a Patriotism ingredient would be added to the vaccine and will be termed as first time ever any vaccine is made in India and then IT CELL will start it's circulation making a person literally God..

This is the real agenda.

- A Kunar, Goa | 08 th July 2020 05:56

 

Dr. Fauci recently announced that CDC is going to release a vaccine by the end of December 2020.

https://www.cnbc.com/2020/05/22/dr-fauci-is-still-confident-us-could-have-a-coronavirus-vaccine-by-december.html

Of course, all that the ICMR is doing is not very clear either. If ICMR is going to do much of the heavy lifting and 'Guide' the hospitals in performing the human trials then it may be OK in these unprecedented times.

Anyway, good analysis Ashwin.

- Jeevan, USA | 06 th July 2020 23:06

 

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