In this illustration, taken on April 10, 2020, small vials labeled with a “COVID-19 Vaccine” label and a medical syringe are seen (REUTERS / Dado Ruvic / Illustration / File photo).
The Serum Institute of India halted trials of the Covid-19 vaccine in India one day after AstraZeneca halted trials following an unexplained illness in a study participant. The volunteer reportedly suffers from symptoms associated with a rare spinal inflammatory disorder called transverse myelitis.
- News18.com New Delhi / London
- Last update: September 10, 2020 5:39 PM IST
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The Serum Institute of India (SII) halted clinical trials of AstraZeneca-Oxford’s Covid-19 candidate vaccine in the country on Thursday until the British drugmaker restarts them.
“We are reviewing the situation and stopping trials in India,” the Serum Institute, the world’s largest vaccine manufacturer by volume, said in a brief statement.
AstraZeneca said Tuesday that it had stopped trials of its experimental coronavirus vaccine after an unexplained illness in a study participant, but its partner IBS had said at the time that trials in India were still ongoing.
The latest announcement from the Serum Institute of India also comes in the context that the central drug regulator Drugs Controller General of India (DCGI) issued a notice of demonstrative cause to IBS for not informing it that AstraZeneca paused clinical trials of the candidate vaccine. from Oxford in other countries. The Pune-based vaccine maker said it is following DCGI’s instructions.
The drug regulator had granted SII approval in August to run phase II / III clinical trials on the main Covid-19 vaccine candidate to determine its safety and immunogenicity.
In the meantime, giving hope, AstraZeneca said that a Covid-19 vaccine could still be available later this year, despite the UK randomized clinical trial being stopped after illness in one participant. The patient reportedly suffered from symptoms associated with a rare spinal inflammatory disorder called transverse myelitis.
“We could still have a vaccine by the end of this year, early next year,” said the company’s chief executive, Pascal Soriot, adding that it depends on how quickly regulators move.
Soriot said during an online event that AstraZeneca was not yet aware of the diagnosis, adding that it was unclear if the volunteer had transverse myelitis and more tests were needed.
Soriot said that the potential vaccine, which the World Health Organization (WHO) has identified as the most promising for the coronavirus, is customary for a trial to be suspended.
“It’s very common, actually, and many experts will tell you this,” Soriot said, adding: “The difference from other vaccine trials is that the whole world is not looking at them, of course. They stop, study, and restart. “
AstraZeneca would supply vaccines to countries at the same time to ensure fair and equitable distribution, Soriot said, adding that the company was close to having the capacity to produce 3 billion doses at established sites around the world to prevent governments from restricting the distribution.
Shares in AstraZeneca fell on Wednesday following news of the trial’s suspension, as some observers raised questions about the timeline for launching a vaccine to help curb the coronavirus pandemic.
With input from Reuters
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