Vaccine maker Serum Institute of India on Wednesday said the ongoing clinical trials in India for the Covid-19 vaccine, developed by University of Oxford and AstraZeneca, will continue and not be affected by AstraZeneca’s announcement of putting trials on hold due to an adverse reaction seen in a vaccine trial participant in the UK.
None of the participants in the Indian leg of the trials being carried out by Serum have faced any problems, the company said.
Serum is partnering with AstraZeneca to carry out trials and manufacture the Covid-19 vaccine doses in India at its Pune facility.
But ICMR scientist Tarun Bhatnagar said as this was a multisite trial, whatever decision was taken by the company at one site should be applicable to all, and this would have an impact on the trials in India. However, there are no details available whether the adverse reaction was related to the vaccine and the trial has been stopped to find that out, Bhatnagar said.
“If the link between the vaccine and the reaction is established, we need to understand if similar adverse event could happen in the Indian population or was it related to a specific population,” Bhatnagar said. It was also not clear whether the reaction came after the first shot or the second shot, Bhatnagar pointed out.
The Oxford vaccine consists of two doses and the second dose is taken 28 days after the first shot. There is no official decision yet as all details are not known about the adverse incident and how many people have been affected, Bhatnagar said.
Commenting on AstraZeneca’s decision to halt the trials in the UK, a Serum spokesperson said, “We can’t comment much on the UK trials, but they have paused for further review and hope to restart soon. As far as the Indian trials are concerned, they are continuing and we have faced no issues at all.”
AstraZeneca on Tuesday said global trials of the Oxford coronavirus vaccine were on hold. It said they were voluntarily pausing vaccination for reviewing the safety data by an independent committee. The company said this was a routine action and happens whenever there is an unexplained illness in one of the trials. It further said they would be looking to expedite the review and minimise any potential impact on the trial timeline.
AstraZeneca and Oxford had started Phase-3 trials for a Covid-19 vaccine in August 2020 with trials in the US, the UK, Brazil, South Africa and India, covering 30,000 participants across 100 sites to assess safety, efficacy and immunogenicity of vaccine ‘AZD1222’ for the prevention of Covid-19.
A total of 1,600 participants are being recruited for the trials from India across 17 sites. Around 100 patients have got the vaccine shots, but Serum has refused to share any details on the trials so far.