English
New Delhi: Reacting to the news report of AstraZeneca halting the vaccine trial after one of the volunteers developed illness, Serum Institute of India CEO Adar Poonawalla on Wednesday said it will not have any impact on the trial of India’s Covid-19 vaccine. He said that AstraZeneca has paused the trial for further review and will restart soon.
“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,” Poonawalla 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 & we have faced no issues at all: Serum Institute of India on reports on AstraZeneca halting the trials. https://t.co/gL7IirfnXy
— ANI (@ANI) September 9, 2020
He further added that nothing untoward has so far been reported during the vaccine trials in India. Saying that the reaction that has been reported from the volunteer is not directly linked to the vaccine, Poonawallasaid the volunteer also had an existing neurological condition.
However, he added that during a vaccine trial such events happen and this is normal.
AstraZeneca, the biopharmaceutical giant in tie-up with the university to produce the vaccine, described the pause as a “routine” one following what was an unexplained illness”.
The trials had moved into Phase III after successful Phase I and II testing had raised worldwide hopes of it being ready by early next year as results showed that it produced a positive immune response.
The vaccine moved to Phase III testing in recent weeks, involving around 30,000 participants in the US as well as in the UK, Brazil and South Africa.
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 a review of safety data by an independent committee, AstraZeneca said.
“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. In large trials illnesses will happen by chance but must be independently reviewed to check this carefully,”it added.
For ChAdOx1 nCoV-19, the so-called Oxford vaccine, clinical trial volunteers are located in countries across five continents, including India, the UK, Brazil, South Africa and the US.
AstraZeneca, the firm partnering Oxford to develop the vaccine, is overseeing a scaling up of manufacturing in parallel with clinical testing so that hundreds of millions of doses can be available if the vaccine is shown to be safe and effective.
(With inputs from PTI)
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