Serum Institute Pauses Oxford COVID-19 Vaccine Trials in India

DCGI had issued a notice to SII for not pausing the trials in India even though UK paused them over health concerns.

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The Serum Institute of India on Thursday, 10 September said that it is officially pausing India trials of Oxford COVID-19 vaccine as per the instructions by the Drugs Controller General of India (DCGI).

SII is the Indian manufacturer of the Oxford vaccine.

“We are reviewing the situation and pausing India trials till AstraZeneca restarts the trials. We are following DCGI's instructions and will not be able to comment further on trials. You can connect with DCGI for more updates on this front,” SII said in a statement.

Move After SII Pulled Up By DCGI

The move comes as pharmaceutical firm AstraZeneca on Wednesday paused its clinical trial for the COVID-19 vaccine as one person developed neurological symptoms, STAT reported.

Following the pause in the UK, SII initially put out a statement saying they were not pausing the Phase 2-3 trials in India.

Subsequently, the Drugs Controller General of India (DCGI), the apex body responsible for overseeing clinical trials, issued a show cause notice to SII for failing to inform them about the pausing of the trial. DCGI wrote to SII regarding safety concerns over the ongoing clinical trials.

(Photo accessed by The Quint)

The notice read, "In view of the above, Drugs Controller General of India and Central Licensing Authority hereby give you an opportunity to show cause... why the permission granted to you on 2 August shall not be suspended till patient safety is established."

Serum reacted by saying they were simply following DCGI's directives.

“We are going by DCGI’s direction and so far were not told to pause the trials. If DCGI has any safety concerns, we will follow their instructions and abide by the standard protocols.”

Serum Institute, India

Why Were Vaccine Trials Halted in UK?

The participant was a woman who experienced neurological symptoms consistent with a rare but serious spinal inflammatory disorder called transverse myelitis, the drug maker’s chief executive, Pascal Soriot, was quoted by the report as saying.

The participant’s health, however, is improving and she is likely to be discharged from the hospital as early as Wednesday, Soriot said.

Earlier on Wednesday, the firm said that it “voluntarily paused” its clinical vaccination trial for COVID-19 and described the health condition of the participant as “unexplained”.

“As part of the ongoing randomised, controlled global trials of the Oxford vaccine, our standard review process was triggered and we voluntarily paused vaccination to allow review of safety data by an independent committee,” the company's spokesperson was quoted as saying, adding that it was a “routine action” in such cases, and was being done to maintain the integrity of the trials.

While AstraZeneca said it was working to expedite the review to "minimise any potential impact on the trial timeline", its US-traded shares were negatively impacted, Bloomberg reported.

First Phase 3 COVID-19 Vaccine Trial Put on Hold

There are currently nine vaccine candidates in Phase 3 trials. AstraZeneca’s is the first Phase 3 COVID-19 vaccine trial known to have been put on hold.

The vaccine candidate, known as AZD1222, employs an adenovirus that carries a gene for one of the proteins in SARS-CoV-2, the pathogen responsible for COVID-19. The adenovirus is designed to induce a protective immune system response against the coronavirus.

It's important to note such a method has not been used in any approved vaccine.

The vaccine candidate, being jointly developed by AstraZeneca and the University of Oxford, had shown promising early results.

‘Exactly Why We Need Large Trials Before Approval’: Expert

Speaking to The Quint, Dr Shahid Jameel said that such effects are exactly why large number of trials are required for the vaccine before it gets approval, as people have several underlying health conditions.

“This is not a bad thing at all. In large randomised efficacy trials an investigational drug or vaccine is given to a large heterogeneous population. Some of these people also have other underlying health conditions and may react adversely. This is exactly why we need large trials before approval. This is also not uncommon in such trials,” he said.

“The good thing is that there is a system in place to recognise these adverse events and address them. This is good and will build confidence in the trials,” he added.