Govt, Bharat Biotech Deny ‘Shortcut’ in Covaxin Trials: What's the Controversy?

COVAXIN has been pulled up by health experts in the past for a lack of transparency in clinical trial data.

COVAXIN clinical trials questioned. Government, Bharat Biotech denies irregularities.

(Photo: FIT)

'Misleading and fallacious' – said Union Health Ministry on 17 November, in response to an investigative report, which said that approval for Covaxin was rushed due to "political pressure."

It all started with an investigative report by STAT that claimed the company rushed the clinical trials of Covaxin, and cut corners under political pressure to 'create a home-grown product that could fulfil the national demand for COVID vaccines'.

The report also says that the health authorities in India backed and endorsed the vaccine, despite glaring discrepancies in it's clinical trial data.

To find out more about what's happening, read on.

The allegations: Here's a quick run through of the STAT report. It said that Bharat Biotech:

• Omitted data of some participants in the phase 1 trial when the study was published in a medical journal.

• Changed protocol of the phase 2 trial testing without any scientific justification.

• The Phase 3 trial was given the go-ahead before phase 2 was completed, and the data was collected.

• It faced 'political pressure' to release the vaccines as quickly as possible, but that, according to a company insider, they 'didn't take any shortcuts'.

How do they know all this?

The report says they had access to internal documents from the company, and they also quote people in the company, including Krishna Mohan, one of Bharat Biotech's directors.

The report also cites protocol documents, and minutes of meetings held by the Central Drugs Standard Control Organization's (CDSCO) Subject Expert Committee that approved these vaccines.

What is Bharat Biotech saying?

In a statement released on 17 November, the company denied 'external pressure', and called the media reports 'incorrect and erroneous'.

However, they also accepted that the phase 3 trial was not conducted based on phase 2 trial data, rather data from phase 1 and animal studies.

The statement doesn't refute other allegations made in the STAT report either – including the claim that changes were made to the clinical trial protocol without justification.

In the news report, Mohan is quoted accepting the claim. He says that 'unusual' steps they had to take to rise up to the unusual situation - the pandemic, but assured that there was no issue with the veracity of the data.

What the government is saying: On 17 November, the Ministry of Health and Family Welfare also released a statement calling the report "completely misleading, fallacious and ill-informed," and denies any irregularities.

It said,

• The CDSCO followed a scientific approach in granting an EUA to COVAXIN.

• The changes to COVAXIN's clinical trials protocol pointed out in the report were made in compliance of due process in CDSCO and with approval from the DGCI.

'A History of Lack of Transparency'

Experts have in the past expressed their concerns regarding the emergency use authorisation (EUA) granted to COVAXIN in January 2021 - two months before the phase 3 clinical trial data was in.

In their statement MoHFW assures that the data was examined by the SEC of the CDSCO before the EUA was granted, but this data was never made public.

In fact, even as the company declared efficacy data, experts have time and time again questioned why the phase 1/2, and phase 3 clinical trial data were not available to the public, or for peer review.

Speaking to FIT in early 2021, epidemiologist Dr Chandrakant Lahariya said, "it is possible that government is looking at that data and using it. But I cannot comment whether the government, experts and government committees have analysed that data or not, as it's not available in public."