Ethics committee waits for reply from ICMR after seeking assurance that Mumbai volunteers should be insured for the same amount as those in other cities
KEM Hospital is one of the hospitals where the vaccine trial will take place. File pic
Despite days of deliberations, the ethics committee is yet to greenlight the Oxford vaccine trial that is to be conducted at two civic-run hospitals. What appears to be holding up the final approval is clarity from the Indian Council of Medical Research (ICMR) on medical insurance for participants, with the committee having been waiting for the council's response for a few days.
The ethics committee, headed by Dr Padma Menon of KEM Hospital, met on August 20 and had further discussions over the next couple of days. A senior civic official said that while medical insurance has to be arranged, the amount needs to be determined.
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A South African Oxford vaccine trialist receives the vaccine in Soweto, South Africa. Pic/AFP
"During the discussions, a point came up that Mumbai cannot have an insurance amount different from the rest of the sites in India. All candidates as part of the phase II trial will have to be granted the same insurance amount. We wrote to the ICMR last week and are yet to get a response," said the official, adding that final approval is expected by the end of the week.
How to register
The trial that will be held at KEM and Nair hospitals will involve 160 patients each. While officials at Nair hospital said they are waiting for the ethics committee's directions, KEM Hospital has set up two helpline numbers for people to call and register.
Nair Hospital is one of the two hospitals where the trial will take place
"Participants must be above 18 years old. An upper limit in age and other physical requirements are unlikely. Participants will be given an RT-PCR test to verify if they have COVID-19 and an antibody test to verify if they have had it," said Dr Hemant Deshmukh, dean, KEM Hospital.
Dr Deshmukh added that the vaccine will be given on an out-patient basis and the only side-effect to look out for is fever for a day or two. "We will keep them under observation for half an hour and then we will keep in touch with them on call. The aim is for people who get the vaccine to develop antibodies," he said.
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He added that while a final decision is yet to be taken, there is likely to be no control group and everyone will get a dose of the vaccine. However, experts say that they don't know how long the antibodies will remain valid.
2
No. of civic hospitals where the trial is to take place
160
No. of participants allowed in each trial
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