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Serum Institute's Decision to Not Halt Vaccine Trials in India Raises Concerns after AstraZeneca Pause

A small bottle labeled with a "Vaccine" sticker stands near a medical syringe in front of displayed "Coronavirus COVID-19" words in this photo taken on April 10, 2020. (REUTERS/Dado Ruvic/Illustration/File Photo)

A small bottle labeled with a "Vaccine" sticker stands near a medical syringe in front of displayed "Coronavirus COVID-19" words in this photo taken on April 10, 2020. (REUTERS/Dado Ruvic/Illustration/File Photo)

The phase three trials of AstraZeneca were stopped in the UK on Wednesday and the pharma firm said it has halted global trials, including large late-stage trials, of its experimental Covid-19 vaccine.

Serum Institute of India (SII) said on Wednesday that trials of AstraZeneca Plc’s potential Covid-19 vaccine in the country is in progress even has AstraZeneca paused global trials. “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," SII said in a statement.

SII was responding to how the halt in trials globally is going to play out in India given that SII is developing a vaccine against Covid-19 in collaboration with AstraZeneca and Oxford University.

On Wednesday, the phase three trials of AstraZeneca were stopped in the UK and the pharma firm said it has halted global trials, including large late-stage trials, of its experimental coronavirus vaccine due to an unexplained illness in a study participant.

AstraZeneca has not given out details on the nature of the adverse reaction in the patient.

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“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," AstraZeneca said in a statement.

Taking the medical fraternity and other vaccine watchers by surprise, Serum Institute said, “We can’t comment much on the UK trials."

“It’s the same vaccine candidate, if there is a safety signal, even if just one, and the UK trial has been suspended till a DSMB looks at the event, why not suspend the Indian study too till that decision is made?" wrote Dr Anant Bhan, Researcher in Bioethics in a tweet.

“The ethics committees for the Indian sites should be intervening," he told News18.

The Pune-based vaccine maker earlier shortlisted 17 sites in India for the Phase II clinical trial of COVID-19 vaccine. At least 1,600 candidates aged between 18 to 55, will participate in the trial. The trials started on August 26 in Pune’s Vidyapeeth Medical College.

In the UK, the Lancet published data on trials of AstraZeneca that indicated that the vaccine candidate produced a dual immune response in people aged 18 to 55.

On the disruption of trials of Oxford University’s vaccine candidate, which has been touted as a front runner, Professor Ashish Jha wrote on Twitter “We have no idea whether this is a big deal or not. Science is hard. This is why we have to let the trials play out. I remain optimistic we will have a vaccine found to be safe and effective in upcoming months. But optimism isn’t evidence."

The government of India, meanwhile, in a press briefing on Tuesday expressed confidence about Serum Institute’s manufacturing capacity.

“Manufacturing capacity of Serum Institute is unimaginable - 75 to 100 million doses per month," Dr VK Paul, head of India’s National Task Force on Covid-19 said.