Manas Dasgupta
NEW DELHI, Sep 9: The expectations of the people in the country for an early arrival of a vaccine for COVID-19 being developed by the Oxford University may have received a set-back due to a “serious adverse event” in the United Kingdom and India putting on hold the trial after first 100 participants administered the shots.
The official sources did not give the details of the “serious adverse event” in the UK but claimed that the “issue is potentially unrelated to the vaccine itself.” The manufacturing company AstraZeneca, however, announced a temporary halt late on Tuesday to the global trials of the Covid-19 vaccine candidate.
The sources claimed that it would not so much impact the vaccine progress in India which had put the trials on hold last week itself awaiting the results of the first 100 shots. “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,” the sources said.
Pune-based Serum Institute of India said the timeline for the mid- and late-stage trial of the candidate would not be impacted as a result of AstraZeneca’s decision. A spokesman for the SII, 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, said, “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.”
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 three trials.
Dismissing the possibility of the UK development seriously impacting the vaccine trials in India, the sources said the SII towards the end of the last month had only initiated the second phase of trials in the country and was still in the process of collating and sending information from the first 100 participants for safety reviews.
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 sources said.
“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,” the sources said and added, “The follow up information for some of the participants is still in the process of being collected.”
“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,” the SII sources said. “The trials had already been paused… so, there is no reason to stop anything and adversely affecting the vaccine progress in India,” the sources 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.
