COVID-19 in Mumbai: KEM, Nair ask ICMR for more vaccine candidates
Nair hospital dean Dr Ramesh Bharmal said that the idea of increasing the number of participants was initiated by the Serum Institute of India (SII)
Before the Oxford vaccine trial was halted, both KEM and Nair hospitals had a target of conducting trials on 160 candidates each. But after the former was resumed last month, as a precautionary measure, the Indian Council of Medical Research (ICMR) decided to reduce the number of candidates to 100 for both the hospitals. Having completed the first round of administering the first dose, senior civic officials said that they recently approached the ICMR to add more candidates for the trial and are awaiting their approval.
Nair hospital dean Dr Ramesh Bharmal said that the idea of increasing the number of participants was initiated by the Serum Institute of India (SII). "They wanted us to add 25 candidates more and approached us a week ago. We have started screening people for it and we can handle more if needed," said Dr Bharmal.
Senior civic officials said that while they were keen on increasing the number of candidates for the trial, they would not be able to wait too long for the ICMR's response to their request.
Additional municipal commissioner, Suresh Kakani said that the civic hospitals had written to the ICMR asking for an additional target. "Initially, we had targeted 160 (per centre) as indicated by the ICMR, but subsequently, the number of candidates were reduced to 100. We communicated to them that we have completed the first dose for all of them and that we are ready to increase the number of candidates if allowed," he said, adding that at the start of the trial, both the hospitals had selected volunteers based on the original target.
He, however, pointed out that waiting too long would disrupt the cycle and the time that needs to be maintained between the doses. "We can handle any number but can start with 25 first. The cycle has to be maintained. If there is a delay then it will be difficult to keep track of the 28-day cycle. Then we'll have to wait for another 28 days to administer the next dose. Hopefully, we'll get the approval from ICMR in a day or two," he said.
Both Nair and KEM hospitals have completed giving the first dose to 100 candidates each and Dr Hemant Deshmukh, dean of KEM hospital, said that they had started giving the second dose as well.
Second dose initiated
Dr Deshmukh said that details about the clinical trial could not be divulged and added, "We haven't heard from the ICMR yet and we are waiting for the approval. Around three to four candidates have already been given the second dose."
As per the protocol of the trial, the same pool of candidates will be involved in phase II and phase III, and they will be monitored for a period of six months. There will be a total of three doses in both the phases. After the first dose is given, 28 days later, the second dose will be given. The candidate will be observed and three months later the third dose will be given.
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