The global trials were halted after a study participant suffered a ‘potentially unexplained illness', reports Sohini Das.
Even as late-stage trials for the United Kingdom arm of the Oxford-AstraZeneca Covid-19 vaccine have been suspended after a study participant suffered a ‘potentially unexplained illness’, India will wait until the country’s drug regulator gives the go-ahead to restart the trials, observed investigators.
The Drug Controller General of India V G Somani will take a call after he receives data from the Data and Safety Monitoring Board in the United Kingdom as well as India.
According to sources close to the development, around 100 participants were administered the first shot of the vaccine (Covishield) in Mumbai. The safety data is being analysed by the DSMB. Unless the DSMB gives its consent, the second shot of the vaccine will not be administered.
A senior investigator of a public hospital, which is one of the 17 trial sites for the Covishield in Mumbai, said, “We will commence the trials once we get DCGI permission. The regulator will analyse the data collated from the UK and the Indian arms of the trial and then take a call,” he said.
The participants were given the first shot of the vaccine and were to receive the second round 28 days later.
An investigator said there was the off chance of the trial getting derailed, subject to the course of the investigation. “If the second shot date is pushed back slightly, that should not be a worry,” he clarified.
A Serum Institute of India spokesperson said, “We are reviewing the situation and pausing the India trials till AstraZeneca restarts them.
“We are following the DCGI’s instructions and will not be able to comment further on the trials. You can connect with the DCGI for more updates,” he added.
SII is the Indian partner of AstraZeneca and is committed to supply 1 billion units of Covishield to the British firm.
On Wednesday, the DCGI had issued a show cause notice to SII, asking why it should not suspend permission granted for trials here until patient safety is established.
Somani had also noted in the letter that SII had not submitted a casualty report of the serious adverse event of the investigational vaccine for continuation of Phase II and III trials here. AstraZeneca India said that there were no further statements from the company at this point in time.
The company had said earlier that an ‘independent committee’ would review the safety data of a single event of an unexplained illness that occurred in the UK Phase III trial. Terming it as ‘routine action’, the firm had said that in large clinical trials, illnesses do happen unexpectedly.
“AstraZeneca is working to expedite the review of the single event to minimise any potential impact on the trial timeline,” it said.
AstraZeneca India did not comment.
