Hyderabad, Jul 7 (PTI) The process of conducting clinical
trials for Covaxin, a vaccine candidate for COVID-19, began on
Tuesday at the Nizams Institute of Medical Sciences (NIMS)
here, a top official of the state-run medical facility said.
"We will select healthy individuals and draw blood and
send the blood samples to designated labs in New Delhi.
They will give the green signal. Then the medicine people
will examine and the first shot of the vaccine will be given
due observation," NIMS director Dr K Manohar told PTI.
The Indian Council of Medical Research (ICMR) has
identified 12 clinical trial sites such as medical
institutions and hospitals, including NIMS, and has asked
their principal investigators to ensure that the subject
enrolment is initiated no later than July 7.
"Everything will be sent to ICMR, where data is analysed.
We have already started the screening of individuals. We will
first take audio visual consent of the individual," the
medical officer added.
Asked about the total number of individuals required for
the clinical trial, Manohar said at least 30 are needed.
The clinical trials proposal was already placed before
the NIMS hospital ethics committee.
The Drug Controller General of India recently granted
permission to initiate Phase I & II human clinical trials for
COVID-19 Vaccine Covaxin- being developed by Bharat Biotech,
in collaboration with the Indian Council of Medical Research
(ICMR) and National Institute of Virology (NIV). PTI GDK APR
Disclaimer :- This story has not been edited by Outlook staff and is auto-generated from news agency feeds. Source: PTI
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