Drug Controller General dodges query on COVID-19 vaccine adverse event

Govt webinar on clinical trials also skips questions on emergency authorisation, expert committees

By Banjot Kaur
Published: Friday 04 December 2020
Drug Controller General avoids query on SII adverse event at press meet. Photo: pxfuel

The Drug Controller General of India (DCGI), VG Somani, dodged questions about the serious adverse event (SAE) in the Serum Institute of India (SII) vaccine trial at his first media interaction since the novel coronavirus disease (COVID-19) was reported in India.

The interaction titled Regulatory Pathways for COVID-19 vaccines, Clinical Trials, Rolling Reviews and Adverse Event Monitoring was a part of the virtual webinar organised by the Union Ministry of Health and Family Welfare.

A 40-year-old participant from Chennai in the SII trial was inoculated with the vaccine on October 1, 2020. He had to be hospitalised eleven days later due to complaints of mental disorientiation.

Down To Earth asked the DCGI as to whether he could explain the sequence of events that led to the conclusion by his office that there was no causality link between the SAE and SII vaccination. A media report, quoting anonymous sources from his office had claimed so December 2.

There is a clear sequence of events laid down in the Clinical Trial and New Drugs Rule, 2019, in case an SAE has occurred. 

“My request was to limit the question regarding understanding the processes involved. About the specifics of the things you are questioning, there are forums…there are weekly press conferences by department / ministry. This question can be asked there,” Mandeep Bhandari, the host of the webinar and a joint secretary in MoHFW said. 


Somani, so far, has never appeared in any press conference in the last 11 months. 

When asked one more time by a journalist, all he could say was the following: “What has been assessed until…that process has been completed…it has been found as per the process the things are going on.” (sic).

Despite several media persons asking questions about the pressing issue, there was still no clear reply from the DCGI. 

A major part of the two-hour-long session was dominated by presentations of the DCGI, a senior scientist of Indian Council of Medical Research and the department of biotechnology.

The DCGI took about an hour just to explain what the rulebook was — what were the three phases of a clinical trial, what was the role of key stakeholders and how adverse events were supposed to be tackled. 

The officials from the two other bodies explained the science and policy parts of clinical trials. 

Somani was asked as to why the trial data was not being put out in the public domain. He said it was too huge to be shared and the regulator of no country had done so. 

He also claimed that if any decision was to be made by the principal investigator of the trial regarding the causality link between an SAE and immunisation, the trial participant was taken into confidence.

However, the fact that the Chennai participant, who has claimed an SAE in the trial, had to send a legal notice to the SII, DCGI, ICMR and others to claim his compensation, hardly indicates that his version was paid heed to. 

Most questions from journalists who sought more transparency were not taken up due to ‘paucity of time’. Several questions regarding the ongoing COVID-19 vaccine trials were also not taken up. 

They included:

  • The composition of ethics committees of institutions where these trials are going on
  • The Central Drugs Standard Control Organisation’s own subject expert committee (SEC)
  • The timeline of the adverse event in the case of the Chennai participant
  • Rules regarding emergency use authorisation of vaccines in India which is expected to be granted in coming days
  • Study designs and protocols
  • Data provided to SEC for granting permission to proceed on progressive phases of trials
  • Criteria for pausing a trial in India
  • Whether the DCGI would put all the related data in the public domain 

One question that was not taken up was on the Data Safety Management Board that oversees the entire trial process. Another query that went unanswered was the one that asked whether vaccination criteria also excluded people who have comorbidities since only healthy volunteers were enrolled for a clinical trial.

Two questions that were answered included the ones on new vaccine platforms and compensation for trial participants. 

The DCGI claimed in his presentation that crores had been awarded as compensation to trial participants. “Rupees 12 crore have been awarded in past trials,” he said in reply to a specific query about quantum. But he did not specify the duration over which this compensation was awarded. 

He was asked whether the country had a robust system in place to evaluate the novel mRNA platform that the SII vaccine was using. “This has to go through a complete evaluation process. A vaccine is allowed for public use only when complete safety is established. Even after it is allowed, active surveillance would continue to take place,” Somani said.

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