Bharat Biotech Begins Its Final Stage For Covaxin

Third phase human trial of India's COVID-19 vaccine begins In Bhubaneswar

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Gaurav Singh
Gaurav Singh
Founder and CEO at Cynosure PR & Communications. Specialized in media relations and brand communications.

INDIA. Bhubaneswar: India’s first COVID-19 vaccine, Covaxin, has been developed and is currently in testing. Covaxin is derived from a strain of SARS-CoV-2 which is isolated by ICMR-National Institute of Virology (NIV), Pune.

According to officials, phase III of the human clinical trial will commence soon in Bhubaneswar. The reports say that the clinical trial will take place in a private hospital. The vaccine was developed by Bharat Biotech in collaboration with the ICMR (Indian Council of Medical Research).

The development of Covaxin

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Last Friday, Bharat Biotech was permitted to conduct the clinical trial phase III with certain conditions by the DCGI (Drugs Controller General of India). ICMR selected 21 medical institutes across the country among which Bhubaneswar’s IMS and SUM Hospital were included for conducting the third phase trial.

On Sunday, the principal investigator in the Covaxin clinical trial, Dr E. Venkata Rao said that the search for a suitable COVID-19 vaccine has almost come to a final stage. Rao is also a professor in the Department of Community Medicine at the Institute of Medical Sciences and SUM Hospital.

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Rao further mentioned that the large-scale efficacy trial involving thousands of volunteers has been planned to post the completion of the first and second phase of the trial with demonstrable safety profile and immunogenicity.

Meanwhile, half of the volunteers would be administered Covaxin while the remaining half would receive a placebo in this phase. For this trial, even healthcare workers will be recruited. The doctor further mentioned that for preventing the development of COVID-19 and checking the efficacy of the vaccine, the volunteers would be followed up over a considerable period of time. Rao also mentioned that the volunteers who offered to help with the trials have been excited to partake in this next step.

Phase III of the clinical trial

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The phase III clinical trial will be conducted in 21 sites across ten states. The states include Lucknow, Patna, Delhi, and Mumbai. It will also be covering around 28,500 subjects with the age group of 18 years and above.

As per the media reports, the application proposed a dose of 0.5 mL on day 0 and 28 for the phase III clinical trial. It further mentions that on 2 October, the vaccine maker had applied to the DCGI seeking permission. This was done to conduct a randomised double-blind placebo-controlled multicentre trial of its COVID-19 vaccine which would make up phase III.

Executive Director, Sai Prasad talked about the future plans of Bharat Biotech regarding the COVID-19 vaccine. According to him, Covaxin is planned to be launched by June 2021. However, the vaccine will be launched earlier if the government decides to give an emergency use authorisation before. In the interim, the company is in talks with more than 10 countries that have shown interest in Covaxin.

With the ongoing pandemic, the government has advised the public to contact the central Helpline Number for COVID-19. A person can call 011-23978046 in case of an emergency.

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