The Drugs Controller General of India issued a notice to the Serum Institute of India on Wednesday after the organisation said trials of the Oxford coronavirus vaccine will continue, even after they were suspended in the United Kingdom because of a volunteer’s illness, PTI reported.
The Serum Institute of India is developing the vaccine in collaboration with AstraZeneca and Oxford University. Earlier on Wednesday, the Serum Institute of India said that its trials of the coronavirus vaccine will continue, even as United Kingdom pharmaceutical major AstraZeneca has suspended it, News18 reported.
“We can’t comment much on the UK trials, but they have been paused for further review and they hope to restart soon,” the institute said in a statement. “As far as Indian trials are concerned, it is continuing and we have faced no issues at all.” The trials are currently in the third and final phase.
On Wednesday evening, Drugs Controller General of India Dr VG Somani asked the institute why permission granted for conducting phase 2 and 3 clinical trials of the vaccine candidate in the country be not suspended till patient safety is established. “Whereas, Serum Institute of India Pvt Ltd, Pune, till now has not informed the Central licensing authority regarding pausing the clinical trial carried out by AstraZeneca in other countries and also not submitted casualty analysis of the reported serious adverse event with the investigational vaccine for the continuation of phase 2 and 3 clinical trials of the subject vaccine in the country in light of the safety concerns,” the notice said.
The drugs regulator also said that if the institute did not reply immediately, it would be construed that it had no explanation to offer, and action would be taken.
The “Oxford vaccine” has been widely seen as one of the leading candidates against the infection. In a statement on Tuesday, AstraZeneca said it was a “routine” pause because of “a potentially unexplained illness”. AstraZeneca said that in large trials, illnesses sometimes happen by chance, and added that it was working to expedite review of this to minimise any potential impact on the vaccine timeline.
The nature and severity of the volunteer’s illness is not clear. According to The New York Times, the participant is from the United Kingdom and was found to have transverse myelitis, an inflammatory syndrome that affects the spinal cord and is often sparked by viral infections. The report said it remains unclear whether the illness was directly linked to AstraZeneca’s vaccine.
Medical fraternity unhappy
The Serum Institute of India’s decision not to halt trials does not seem to have gone down well with the medical fraternity. Former International Association of Bioethics President Dr Anant Bhan tweeted that the trial ought to be halted for the present.
“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 [Data and Safety Monitoring Board] looks at the event, why not suspend the Indian study too till that decision is made?” he asked. “The ethics committees for the Indian sites [for testing] should be intervening.”
As many as 17 sites in India are conducting testing for the vaccine. It is being tested on individuals between the ages of 18 and 55. The trials began on August 26.
Oxford’s vaccine, called AZD1222, had produced an immune response against the coronavirus and proved to be safe in early-stage clinical trials, according to trial results published in medical journal The Lancet.
Over 100 vaccines are being developed around the world to tackle the coronavirus pandemic. As of Wednesday evening, the global tally of cases stood at 2,76,28,190, according to the Johns Hopkins University. As many as 8,98,757 people have died, and 1,85,90,528 have recovered.