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Vaccine-maker Serum Institute of India has also paused trials on the Covid-19 vaccine candidate from the AstraZeneca-Oxford University combine.
“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,” said a note from the company.
The development comes a day after AstraZeneca said it had paused late-stage clinical trials on the AZ-Oxford University vaccine candidate due to a “potentially unexplained illness” in one participant in the United Kingdom. Serum Institute has a production and supply alliance on this vaccine that was undergoing late-stage Phase II/III trials in India. But it struck a different note from AstraZeneca yesterday by saying it was continuing with the trailas they did not have an issue here.
However, since AstraZeneca had stopped trials in other countries as well, the Drug Controller General of India (DCGI) then sent Serum Institute a show-cause notice. The notice said that the Central licensing authority had not been informed about the trial being paused by AstraZeneca in other countries and the company had “not submitted casualty analysis of the reported serious adverse event with the investigational vaccine”. Serum was asked to respond “immediately”. Serum clarified later last night that it would abide by the standard protocols.
Vaccine on track
Meanwhile, AstraZeneca Chief Executive Officer Pascal Soriot is reported to have said at an event that the vaccine would be ready by the year-end, despite the pause because of a possible serious neurological event.
“The decision on whether to resume the study is in the hands of a group of independent experts working to understand whether the patient’s illness was a coincidence or a result of the vaccine. The reality is we all have to be very patient and see how it unfolds,” said a Bloomberg report quoting him.
Greater clarity is awaited from AstraZeneca and the Oxford University on the nature of the adverse event, and whether it was linked to the vaccine. Besides the UK, the US, Brazil, South Africa and India were participating in the Phase II/III trials. No timeline was available on the restart of the trial either, if indeed it was just a pause.
The Oxford vaccine is among a handful of candidates that are in late-stage trials, required to get final approvals before it is ready for mass use. Experts point out that pausing trial to assess the adverse event was, in fact, an indicator of good clinical practices. Other companies listed with promising candidates include Moderna and Pfizer, BioNTech, and are also expected to come out with trial data this month. This is even as China and Russia claim to already have safe Covid vaccines.