While clinical trial sites conducting the testing in India are awaiting more information on the adverse event, some said they have been informally told that the issue is potentially unrelated to the vaccine itself.While AstraZeneca announced a temporary halt late on Tuesday to the global trials of the Covid-19 vaccine candidate developed by the University of Oxford due to a serious adverse event in the United Kingdom, recruitment of participants in India had already been put on hold last week after the first 100 participants were administered the shot.
The adverse event seen in the UK case has not been noted in any of the Indian participants so far. However, it is likely to be taken up by a safety expert group which will review information collected from the first set of participants in the human clinical trials in India.
While clinical trial sites conducting the testing in India are awaiting more information on the adverse event, some said they have been informally told that the issue is potentially unrelated to the vaccine itself.
Pune-based Serum Institute of India, meanwhile, said the timeline for the mid- and late-stage trial of the candidate here will not be impacted as a result of AstraZeneca’s decision. SII has been contracted by AstraZeneca and the University of Oxford to manufacture the vaccine for low- and middle-income countries and is the sponsor of the trials underway in India.
“We can’t comment much on the UK trials, but they have been paused for further review and they hope to restart soon. As far as Indian trials are concerned, it is continuing and we have faced no issues at all,” stated the firm.
The vaccine candidate was already undergoing phase 2/3 trials in the UK since the end of May, and AstraZeneca announced on September 3 that centres in the US were recruiting up to 30,000 participants to initiate phase 3 trials.
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SII only initiated the second phase of trials in India towards the end of last month, and is still in the process of collating and sending information from the first 100 participants for safety reviews, The Indian Express has learnt.
The review group, known as a ‘Data Safety and Monitoring Board (DSMB)’, is scheduled to meet by the end of this week to study the data and decide whether the vaccine candidate is safe enough to be administered to more participants in India, sources close to the development said.
Not all sites in the country have begun the phase 2 trials, which are conducted to test how effective the vaccine is. Trials have begun at only three sites, and the follow-up information of the first 100 participants are to be collected and sent to the DSMB after seven days of vaccination, The Indian Express has learnt.
“The last vaccinations were completed last week around Tuesday or Wednesday, so the data are likely to be collected and sent this week to the DSMB,” said a source on condition of anonymity.
The follow up information for some of the participants is still in the process of being collected, another source said.
The understanding is that along with the Indian data, this issue will also be discussed by the DSMB “once more details are available” from AstraZeneca.
“The DSMB will review the Indian data along with this particular event that has occurred, and then decide and let us know what has to be done,” one of the investigators of the trial sites that is to be conducting the testing in India, said.
“The trials had already been paused… so, there is no reason to stop anything,” this investigator added.
Some investigators are awaiting a formal communique from Serum Institute to understand the exact nature of the issue, and its severity.
“We have been told (by the sponsor) that this is unrelated… but we have no data and have not seen anything (to ascertain this) yet,” an investigator said.
“As part of the ongoing randomised, controlled global trials of the Oxford coronavirus vaccine, our standard review process was triggered and we voluntarily paused vaccination to allow review of safety data by an independent committee. This is a routine action which has to happen whenever there is a potentially unexplained illness in one of the trials, while it is investigated, ensuring we maintain the integrity of the trials,” stated AstraZeneca. “In large trials illnesses will happen by chance but must be independently reviewed to check this carefully. We are working to expedite the review of the single event to minimise any potential impact on the trial timeline. We are committed to the safety of our participants and the highest standards of conduct in our trials.”
Other countries where the vaccine candidate is being tested include Brazil and South Africa, while trials have also been planned in Japan and Russia.