The Drug Controller General of India (DGCI)has issued a showcause notice to vaccine maker Serum Institute of India (SII) after trials of the AstraZeneca Covid vaccine were halted in the UK as a participant felt sick.
Sources confirmed to India Today that the showcause notice was issued to SII as they had not revealed to DGCI the trial outcomes that have led to one participant falling ill in the UK trials of the AstraZeneca vaccine.
SII is the Indian manufacturer of the Covid vaccine developed by the Jenner Institute of Oxford University in collaboration with the British-Swedish pharmaceutical company AstraZeneca. The Oxford Covid vaccine is considered to be the most promising Covid-19 vaccine candidate globally.
The DCGI notice states, SII “has not informed the central licensing authority regarding the pausing of the clinical trial carried out by AstraZeneca in other countries” adding that SII “has not submitted the causal analysis of the reported serious adverse event with the investigational vaccine for the continuation of the Phase 2/3 trial of the subject vaccine in the country in the light of safety concerns”.
The Drugs Controller General of India in the showcause notice has asked SII as to why the permission granted for conducting phase 2 and 3 clinical trials of the vaccine candidate in India should be not suspended till patient safety is established.
Last month, the DCGI had granted permission to the Pune-based SII to conduct Phase 2 and 3 human clinical trials of the coronavirus vaccine candidate with 1,000 participants across 17 hospitals in the country.
“In view of the above, the Drugs Controller General of India and central licensing authority hereby give you an opportunity to show cause as per provided under rule 30 Of the new drugs and clinical trial rules 2019 — Why the permission granted to you on August 2 should not be suspended till patient safety is established,” states the notice accessed by India Today TV.
With trials of the Oxford vaccine trial being halted first in the UK and then in other countries, things are not looking good for the SII in India as well. In the show-cause notice, the drug regulator also mentioned that the clinical trials have been put on hold across countries where it is conducted i.e. USA, UK, Brazil and South Africa.
“The halting of trial in the UK is likely to have an impact on phase 3 trials of the Oxford vaccine in India as well,” said a source in the government.
Therefore, the DGCI is seeking an explanation from the vaccine manufacturing company.
SII SAYS NOT ASKED TO STOP TRIALS, WILL FOLLOW PROTOCOL
Meanwhile, Serum Institute of India (SII), which has partnered with AstraZeneca for manufacturing the Oxford vaccine candidate for Covid-19, on Wednesday said it is continuing with the trials in India.
Releasing a statement on the notice, the Serum Institute of India said, “We are going by DCGI’s direction and so far were not told to pause the trials. If DCGI has any safety concerns, we will follow their instructions and abide by the standard protocols.”
Commenting on the recent reports on AstraZeneca halting the trials in the UK, SII said in a statement: “We can’t comment much on the UK trials, but they have been paused for further review and they hope to restart soon.”
It further said: “As far as Indian trials are concerned, it is continuing and we have faced no issues at all”.
ASTRAZENECA STOPS GLOBALTRIALS AFTER PATIENT FALLS ILL
AstraZeneca has suspended global trials of its experimental coronavirus vaccine after an unexplained illness in a participant in Britain, casting doubt on prospects for an early rollout.
AstraZeneca said on Tuesday it had paused trials, including late-stage ones, to allow an independent committee to review safety data, and it was working to minimise 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.
AstraZeneca said a woman in the United Kingdom had symptoms consistent with a rare but serious spinal inflammatory disorder, which led to the British drugmaker’s decision to stop its clinical study of the new coronavirus vaccine, Stat News reported on Wednesday.
“This is a routine action which has to happen whenever there is a potentially unexplained illness in one of the trials,” the AstraZeneca said in an emailed statement.
A separate report from the Financial Times noted that AstraZeneca could resume trials of its experimental coronavirus vaccine next week.
The stakes are high because AstraZeneca, Britain’s largest drugmaker by market value, has already agreed to supply close to three billion doses to governments across the globe.
The company’s shares closed 0.5% higher at 8,230 pence on Wednesday. They slipped earlier in the day as the halt was seen as dimming prospects for an early rollout of the vaccine hopeful was seen among the leading candidates.
Safety is paramount in vaccine clinical trials and temporary suspensions are not unusual to evaluate any unexplained illness in a participant, the World Health Organization (WHO) said on Thursday regarding the pause in an AstraZeneca Covid-19 trial.