Covaxin has entered phase III of clinical trials at the All India Institute of Medical Sciences (AIIMS).
Covaxin, the COVID vaccine candidate by Hyderabad-based vaccine manufacturer Bharat Biotech Limited, being developed in collaboration with the Indian Council of Medical Research (ICMR), is likely to be available for use of the general public by the end of February 2021, Dr Sanjay Roy, principal investigator (PI) heading its clinical trial at AIIMS, said on Tuesday.
"We can hope the general population will get their hands on the vaccine doses by February," he stated.
Roy also said that two indigenous vaccine candidates which are frontrunners, expected to hit the market shelves before the end of the first quarter of 2021. "The Covishield by Serum Institute of India (SII) is also a frontrunner and also in the third phase of clinical trials. I expect it to be available for public use around the time of Covaxin," he added.
Covaxin has entered phase III of clinical trials at the All India Institute of Medical Sciences. Roy said that more than 100 volunteers have already received the first dose of the vaccine candidate.
He also informed that a target of 26,000 volunteers is set for the phase III clinical trial of the Covaxin. The volunteers would receive two intramuscular injections at a period of 28 days apart. The trial is double blinded and the volunteers will be randomly assigned to receive COVAXIN or placebo. The investigators, participants and the company will not be aware of who is assigned to which group.
The lowest age kept for the eligibility to enroll in the trial is kept at 18 years. The volunteers who wish to participate in this trial should be adults over 18 years of age.
Bharat Biotech has applied for emergency use authorisation (EUA) to Drug Controller General of India (DCGI) on Monday, a day after SII applied for the same on Sunday.
Apart from these two, US-based pharma giant Pfizer Inc had also submitted an application on December 4 to the DCGI seeking EUA for its COVID-19 vaccine in India.
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The Covaxin recently made news after its VIP participant, Haryana's Health Minister Anil Vij tested positive for the novel coronavirus two weeks after being administered the trial vaccine shot.
The union health ministry informed on Tuesday that as many as eight COVID vaccine candidates are under different stages of clinical trials which could be ready for authorisation in near future.
The vaccines include Covain, Astrazeneca and Oxford university developed and Serum Institute of India manufactured Covishield, ZyCoV-D by Zydus Cadila, Russian vaccine candidate Sputnik-V, NVX-CoV2373 by SII, HGCO19 by Geneva, and two unlabelled vaccines - Recombinant Protein Antigen-based vaccine by Biological E Limited and Inactivated rabies vector platform by Bharat Biotech Limited.
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