DCGI serves show cause notice to Serum as Oxford vaccine trials in India continue without trouble with volunteers showing no side effects
Even as AstraZeneca has paused trials of its Covid-19 vaccine candidate after one of the participants in the United Kingdom developed an unexplained illness, at least 100 volunteers in India have completed the crucial week after receiving shots in the phase 2 human trials, without showing any adverse reaction.
However, the central drug regulator Drugs Controller General of India (DCGI) issued a show cause notice to Serum institute of India (SII) for not informing them about AstraZeneca pausing the clinical trials in other countries and also for not submitting casualty analysis of the “reported serious adverse events”. Dr VG Somani, the Drugs Controller General of India in his show cause notice has asked SII as to why the 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.
On the show cause notice issued by the DCGI, SII, 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.”
Pune-based Serum institute of India (SII), the world’s largest vaccine maker, has signed an agreement to manufacture the potential vaccine developed by the Jenner Institute of Oxford University in collaboration with British-Swedish pharma company AstraZeneca. AstraZeneca announced a pause on clinical trials after a volunteer developed an unexplained illness in the UK, just hours after it joined eight other drug makers to make an unusual safety pledge.
Earlier in the day, while clarifying on AstraZeneca putting on hold trials, SII clarified that the Indian trials of the Covishield vaccine candidate are continuing without any problems.
Commenting on the reports of AstraZeneca putting on hold trials in UK, SII in a statement said, “We can’t comment much on trials in the UK. But they have been paused for further review and they hold to restart soon. The Indian trials are continuing and we have faced no issues at all.”
Of the 100 volunteers, 34 were from Bharati Vidyapeeth Medical College and hospital in Pune, who have been administered vaccine shots after trials for phase 2 began in India on August 26.
According to doctors at the medical college and hospital, none of the 34 volunteers have shown any sign of health-related complications, with all their vital parameters appearing normal. Besides Bharati Vidyapeeth, two other hospitals in Pune are carrying out trials, including the KEM.
“We have completed the phase two trials of 100 enrolments in India, of which 34 were from Bharti Vidyapeeth. It’s been a week after the shots were given to 34 volunteers at our institute and none of them showed any adverse reaction,” said Dr Sanjay Lalwani, medical director at Bharti Vidyapeeth medical college and hospital.
The KEM hospital, which carried out trials at its Vadhu campus, has also completed the process. A senior doctor at the hospital said, “We have given shots to some volunteers and none have shown any side effects so far,” said the doctor declining to share exact number of volunteers undergoing trial. Besides KEM, CS Medical College and hospital has been selected for Phase-2 trials.
The entire data about volunteers and the results of trials, according to Lalwani, has been submitted to SII. The data in turn will be picked up by Data System Monitoring Board at Drugs Controller General of India (DCGI) level for further review.
“We have submitted the data about all the participants. We are now awaiting directions from SII. If there is any official communication, we will start enrolment for third phase,” said Lalwani.
(With PTI inputs)
Eligibility criteria for volunteers during Phase 2 trials
Person is aged between 18-99 years
No co-morbidities
He or she has to be tested negative for the SARS-CoV-2 virus
He or she should not have antibodies of the virus
Administered how?
The 0.5 ml dose is given intramuscularly
Who bears the cost of trials?
While candidates will not be given any compensation for trails, hospital borne the cost of tests and trails along with any medical treatment to volunteers, if necessary
Phase -3 trial
Over 1500 people across India to be administered Covishield vaccine if results of Phase -2 are as per standards laid out by Oxford. Phase -3 trials will determine if the vaccine can induce immunity
Vaccine production at SII
SII has already started producing vaccine at its plant in Manjri near Pune
Earlier this week, SII stated filling up doses in glass vials