Govt neither denies nor accepts adverse event in Serum Institute COVID-19 vaccine trial

Health secretary claims all procedures followed but refuses to divulge details

By Banjot Kaur
Published: Tuesday 01 December 2020

The government December 1, 2020, neither denied nor accepted that a serious adverse event (SAE) had happened to a trial participant of the Serum Institute of India (SII)-Oxford AstraZeneca novel coronavirus disease (COVID-19) vaccine.  

Most of the questions in the Union Ministry of Health and Family Welfare press conference were about reports of a SAE occurring with a participant, that surfaced in November. The conference was addressed by ministry Secretary Rajesh Bhushan and Indian Council of Medical Research (ICMR) Director-General Balram Bhargava.

Bhargava, replying to one of the questions in the conference, said, “Initial causality assessment findings did not necessitate the stoppage of this trial.” He thus indicated that there was no causal link between the SAE and vaccine. He added the institution ethics committee (IEC), data safety monitoring board (DSMB) and principal investigator had submitted reports to the drug controller general of India (DCGI).

To put things in perspective, such trials are conducted at multiple sites and, therefore, every site has an IEC. An IEC, among other things, has to investigate adverse events at the respective sites. The IECs are independent of the company conducting the trial and also the government. For all such trials, there is a principal investigator who oversees them. The DSMB provides an oversight for the ethics of the trial. The DSMB is also independent. 

A normal adverse event includes pain in the injection site or headache. If hospitalisation is warranted, it is termed as an SAE. However, when Bhargava was asked again about the causality part, he said, “The final assessment will be done by the DCGI. I would not know when it would be completed.” Also, other trial participants had not been informed of the adverse event as the assessment was ongoing, he said.

Questions unanswered

When the first question was asked about the SAE, Bhushan said, media discourse was often based on inadequate information. Among other things, he asked the media to study the New Drugs and Clinical Trial Rules, 2019. 

According to those rules, there are time-bound limits to act in the case of an SAE. Were they carried out? Some of the key provisions include. 

1. The sponsor, in this case, the SII and the investigator shall forward their reports on an SAE to the Central Licencing Authority (DCGI), the ethics committee and the head of the institution where the trial was conducted within 14 days of the reporting of the event

2. The ethics committee shall forward the report of its analysis and compensation to be given by the sponsor within 30 days of knowing that the adverse event had occurred

3. The DCGI shall pass an order or constitute an independent expert committee for this. The expert committee will take a call on causality and compensation, if any, within a period of 60 days of the event

4. The company conducting the trial shall have to comply by the DCGI order and pay compensation, if any, within 30 days of the event

The SAE happened with the 40-year-old Chennai resident October 11, more than 30 days ago from December 1. The DCGI has, till date, not come out in public saying whether this sequence of events was followed and if yes, what was the outcome.

When Down To Earth (DTE) asked Bhushan the details of the procedure followed in this case, he said, “Please don’t assume that the rules were complied with.” He did not reply as to why the DCGI or any other organ of the government or even the company did not deem it fit to make a suo motu disclosure of the adverse event. 

“The fact that adverse event happened should not surprise us because they are bound to happen in clinical trials. And that is why clinical trials are so important to establish safety beyond doubt. But what is surprising is neither the government nor the company decided to share it till the participant himself sent a legal notice,” bioethics researcher Anant Bhan told DTE.

Bhushan also said at one point that he would not like to go into the details as the matter was sub judice. However, the matter is not, yet. The trial participant had sent a legal notice November 21, 2020.

Talking to DTE, his lawyer, R Rajaram said, “We have given two weeks’ time to them. We would move court only after the time limit expires.”

The trial participant was inoculated with the vaccine October 1 at Ramachandra Institute of Higher Education and Research, Chennai. The legal notice sent by Rajaram claimed that the participant reported headaches and disorientation October 11. The next day, he was hospitalised. He remained in hospital for 16 days including an 8-day admission in the intensive care unit. 

After his discharge from hospital, there had been no follow-up, which is mandatory in a clinical trial. Nobody from the hospital, SII, ICMR or even Oxford University and AstraZeneca Inc got in touch with him. 

The trial participant has demanded Rs 5 crore as compensation. In turn, the SII has threatened him a defamation case and penalty of Rs 100 crore.

Dangerous precedent

“I am hearing for the first time that instead of responding to the participant’s concern, the vaccine manufacturer has been threatening him with a legal notice. This will set a dangerous precedent,” Bhan said. 

Incidentally, AstraZeneca had to pause global trials including, in India, for six days after a participant in the UK trial reported neurological complications. It was resumed after they were properly looked into.

“If adverse events in other countries can lead to a pause in the trial, we could have done that too. If not that, the Indian authorities could have at least suo motu made it public and assured that they were looking into it. This would have instilled confidence and also dispelled unfounded fears in the public which leads to vaccine hesitancy,” Bhan said. 

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