“We are reviewing the situation and pausing India trials,” Serum said in a brief statement.
AstraZeneca said on Tuesday it had paused trials of its experimental coronavirus vaccine because of an unexplained illness in a study participant, but its partner Serum had at the time said its trials in India were still ongoing.
AstraZeneca, which is developing the vaccine with Oxford University researchers, said on Tuesday it had paused late-stage trials to allow an independent committee to review safety data, and it was working to minimize any potential impact on the timeline.
“It is obviously a challenge to this particular vaccine trial,” Britain’s health secretary Matt Hancock told Sky News.
The patient was reportedly suffering from neurological symptoms associated with a rare spinal inflammatory disorder called transverse myelitis. AstraZeneca on Wednesday said a final diagnosis was still pending as more tests are carried out.
AstraZeneca, Britain’s largest drugmaker by market value, has already agreed to supply close to three billion doses to governments across the globe – more than any other vaccine project.
The company also confirmed on Wednesday that it had briefly suspended the vaccine trial in July after a study volunteer was found to have multiple sclerosis. An independent review panel concluded the MS was not related to the vaccine.
Asked whether the latest pause would set back the development process, Hancock said: “Not necessarily, it depends on what they find when they do the investigation.”