The Serum Institute of India (SII) on Thursday paused clinical trials of AstraZeneca-Oxford’s Covid-19 vaccine candidate in the country until the British drugmaker restarts them.
“We are reviewing the situation and pausing India trials,” Serum Institute, the world’s biggest vaccine manufacturer by volume, said in a brief statement.
AstraZeneca said on Tuesday it had paused trials of its experimental coronavirus vaccine following an unexplained illness in a study participant, but its partner SII had said then that trials in India were still ongoing.
The Serum Institute of India’s latest announcement also comes against the backdrop of the central drug regulator Drugs Controller General of India (DCGI) issuing a show-cause notice to SII for not informing it about AstraZeneca pausing the clinical trials of the Oxford vaccine candidate in other countries. The Pune-based vaccine maker said it is following instructions of the DCGI.
The drugs regulator had in August given SII approval to run Phase II/III clinical trials on the leading Covid-19 vaccine candidate to determine its safety and immunogenicity.
Giving hope, meanwhile, AstraZeneca said a Covid-19 vaccine could still be available by as early as the end of this year, despite the randomised clinical trial in the UK being paused after an illness in a participant. The patient was reportedly suffering 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," the company’s chief executive Pascal Soriot said, adding it depended on how fast regulators moved.
Soriot said during an online event that AstraZeneca did not yet know the diagnosis, adding that it was not clear if the volunteer had transverse myelitis and more tests were needed.
Soriot said that the potential vaccine, which the World Health Organization (WHO) has flagged as the most promising for coronavirus, that it was usual for a trial to be suspended.
“It’s very common, actually, and many experts will tell you this," Soriot said, adding: “The difference with other vaccine trials is, the whole world is not watching them, of course. They stop, they study, and they restart."
AstraZeneca would supply vaccines to countries at the same time to ensure a fair and equitable distribution, Soriot said, adding that the company was close to having capacity to produce 3 billion doses at sites set up around the world to prevent governments from restricting distribution.
Shares in AstraZeneca fell on Wednesday after news of the trial’s suspension as some observers raised doubts about the timeline for the rollout of a vaccine to help curb the coronavirus pandemic.
With inputs from Reuters