03 November,2020 07:09 AM IST | Mumbai | Arita Sarkar
Nair hospital also has 48 more participants in the trial now. Representation pic
Both KEM Hospital and Nair Hospital, centres for the ongoing Oxford vaccine trial for COVID-19, have finished administering the first dose to participants and have started with the second round. While both centres had asked for an additional target, Nair received the approval of the Indian Council of Medical Research (ICMR) and added 48 participants.
Late last month, a representation was sent to ICMR of adding more participants to the existing quota of 100 candidates for each hospital.
Representation pic
Dr Ramesh Bharmal, dean of Nair hospital, said, "We had asked for permission from the ICMR and since AIIMS has fewer candidates, we were allowed to add more. We have given the first dose to all candidates and the second round started last week," he said.
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Dr Bharmal added that so far around 12-15 candidates have received the second dose and no one has reported side effects.
The BCG vaccine trial is being done on adults to fight COVID-19. Representation pic
"A few of the candidates reported mild effects like fever and body ache that can be treated with paracetamol. No one has any major side effects and the trial is going well so far," he said.
Additional Municipal Commissioner Suresh Kakani said that KEM Hospital has maintained the original target of 100 candidates and has started giving the second dose.
KEM Hospital. File pic
As per the protocol, the same pool of candidates will be involved in the Phase II (two doses) and phase III (single dose) of the trial and will be monitored for six months. The second dose in Phase II is given 29 days after the first one and three months later, the third dose is given.
Apart from the Oxford trial, KEM Hospital is also managing the BCG vaccine trial for COVID-19 and ICMR has increased the sample size for the trial from 1,450 to 1,555 candidates along with 778 participants as part of the control group.
Dr Rujuta Hadaye from the Department of Community Medicine who is heading the trial said, "Since the sero positivity rate was high, ICMR increased the target and added centres in September. A deadline for October 30 was given. However, we are still working and will finish by the end of this month."
Dr Hadaye said that they have screened more than 275 people till date and have given the vaccine dose to nearly 100 people. To speed things up, Dr Hadaye said that ICMR added five centres to the existing six, which reduced the target for each of them.
3
Total no. of phases in the Oxford vaccine trial
12-15
Candidates at Nair who got second dose of vaccine
148
Total no. of participants in Nair hospital trial
02
No. of doses in Phase II of the Oxford vaccine trial
1,555
No. of target participants in the BCG vaccine trial
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