Coronavirus vaccine India: Clinical trials of coronavirus vaccine begin in India: All you need to know | India News

NEW DELHI: As India races to bring a vaccine for Covid-19 by mid August, the process of conducting clinical trials for Covaxin, a vaccine candidate for coronavirus, has begun at the Nizams Institute of Medical Sciences (NIMS) in Hyderabad, a top official said.
Covaxin by Bharat Biotech and ZyCov-D vaccine by Zydus Cadila are India’s own efforts to bring a vaccine for this pandemic. The government also six Indian companies are working on a vaccine for Covid-19.
Here is all you need to know about the progress of the vaccine:
Human trials at NIMS
* At NIMS, healthy individuals will be selected to draw blood and then the samples will be sent to designated labs in New Delhi.
* After they get a green signal, the first shot of the vaccine will be given due observation.
* 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, NIMS director Dr K Manohar said.
* Authorities at NIMS began the process to register 30-60 subjects for the trial.
How will the vaccine dosage work?
* After receiving the test reports, the department of medicine at NIMS will analyse the same and issue the fitness certificates to the subjects.
* The subjects would be administered two doses of the vaccine. There will be two vaccine dosage of three micrograms and six micrograms, and a 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 for two days in the ICCU at NIMS by a team of doctors, after which they would be sent home and monitored through videoconference or phone.
Phases of the vaccine trial
* The phase-I clinical trial would go on for 28 days.
* The phase-I would have around 375 subjects across the country.
* After the phase-I, the ICMR and the Drug Controller General of India (DGCI) would accord permission for Phase-II trial with more subjects.
* Phase-II would have 875 subjects.
ICMR’s progress on the Covid-19 vaccine
* 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.
* In a letter to the heads of the selected institutions last week, ICMR director general Balram Bhargava asked them to fast-track all approvals related to initiation of the clinical trials.
* He noted that this is the first indigenous vaccine being developed by India and is one of the top priority projects that is being monitored at the topmost level of the government.
ICMR vaccine deadline
* No vaccine has yet been approved for commercial use against Covid-19 but over a dozen vaccines from more than a 100 candidates globally are being tested in humans.
* India making its headway in the vaccine race earlier this week allowed one of the vaccine candidates to move to human clinical trials.
* The ICMR envisaged to launch the vaccine for public health use latest by August 15, 2020 after completion of all clinical trials.
* The apex health research body stressed that it is acting in accordance with the globally accepted norms to fast-track vaccine development for diseases of pandemic potential.
* It said that the BBIL is working expeditiously to meet the target; however, the final outcome will depend on the cooperation of all clinical trial sites involved in this project.
Experts raise questions on deadline
* While experts raised doubts on the August 15 target, the ICMR defended it, saying its process is in accordance with the globally accepted norms to fast-track vaccine development for diseases of pandemic potential.
* Anant Bhan, of the Department of Forensic Medicine at Kasturba Medical College, Manipal, among others had questioned the timeline of the announcement. “To my knowledge, such an accelerated development pathway has not been done EVER for any kind of vaccine, even for the ones being tried out in other countries. Even with accelerated timelines, this seems really rushed, and hence with potential risks, inadequate attention to process,” Bhan said.
* Virologist Upasana Ray noted while an accelerated launch or promise for launch for a vaccine against novel coronavirus deserves applause, we also have to think if we are rushing too much.
* BBIL has also refused to comment on ICMR’s August 15 deadline. The company had announced on June 29 that it had successfully developed Covaxin, India’s first vaccine candidate for Covid-19, in collaboration with the ICMR and NIV.
What is Covaxin
* Covaxin is India’s first vaccine candidate to have gone into human clinical trials.
* Bharat Biotech, the Hyderabad-based vaccine major, announced last week that its Covid-19 vaccine candidate has been approved by the Drug Controller General of India for phase I and II human clinical trials.
* The SARS-CoV-2 strain was isolated in NIV, Pune and transferred to Bharat Biotech. The indigenous, inactivated vaccine developed and manufactured in Bharat Biotech’s BSL-3 (Bio-Safety Level 3) High Containment facility located in Genome Valley, Hyderabad, India.

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One thought on “Coronavirus vaccine India: Clinical trials of coronavirus vaccine begin in India: All you need to know | India News

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