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Clinical trials for Covid-19 vaccine begin in Hyderabad’s NIMS
The Nizam’s Institute of Medical Sciences (NIMS) is among the 13 hospitals chosen by Indian Council of Medical Research (ICMR) for clinical trials of the first indigenous vaccine for Covid-19 developed in collaboration with Hyderabad-based Bharat Biotech Limited.
Clinical trials for a Covid-19 vaccine began at the Nizam’s Institute of Medical Sciences (NIMS) in Hyderabad on Monday with hospital authorities administering the first vaccine dose to two volunteers.
NIMS is among the 13 hospitals chosen by Indian Council of Medical Research (ICMR) for clinical trials of the first indigenous vaccine for Covid-19 developed in collaboration with Hyderabad-based Bharat Biotech Limited.
In the first phase, the vaccine would be tested on around 375 subjects and in the second phase 875 would be tested across the country. In Hyderabad, as many as 30 volunteers have registered with the NIMS for the clinical trials.
“Of them, seven more subjects are available and they would be administered the vaccine in the next few days,” NIMS director Dr K Manohar said.
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According to an official familiar with the development, the volunteers are being drawn from different parts of the state. These subjects would be administered two doses of the vaccine. There will be three types of vaccines — three micrograms, six micrograms and placebo. Each subject would be given the second dose of the same vaccine after 14 days.
For two days after administering the vaccine, the subjects would be monitored by a team of doctors in the Intensive Critical Care Unit (ICCU) before being discharged.
“Their health condition will be monitored from time to time. The doctors would also look into the interaction with the vaccine digitally as well as through frequent physical check-ups,” the official said.
Meanwhile, King George Hospital (KGH) in Andhra Pradesh’s D, which was also selected by the ICMR for clinical trials for Covid-19 vaccine, is yet to commence the exercise.
“We have got the approval from the ICMR, but are yet to get the clearance from the state government. We have written to the Director of Medical Education to give the nod for clinical trials and once we get it, we shall start,” Dr K Indira Devi, in-charge superintendent of the KGH, told Hindustan Times.
She said the selection of subjects would be done only after getting an approval from the state government. “As of now, we have not identified any subjects,” she said.
The first phase of clinical trials would go on for 28 days, after which ICMR and Drug Controller General of India (DGCI) would accord permission for the second phase which will include more subjects.
