Bharat Biotech said last month that regulatory approvals for the vaccine were in the process in over 60 countries, including the US, Brazil, Hungary.
Bharat Biotech’s vaccine Covaccine (file photo)
Hyderabad-based company Bharat Biotech has submitted the data of Phase-3 clinical trial of its COVID-19 vaccine ‘Covaccine’ to the government. The news agency ANI quoted Indian government sources as saying that the data for the third phase of the vaccine was handed over to the Drug Controller General of India (DCGI) over the weekend. Covaccine is the first indigenous vaccine made in India against the corona virus, which the company has developed in collaboration with the Indian Council of Medical Research (ICMR).
Questions have been raised many times regarding the Phase-3 trial data of Covaccine. However, Bharat Biotech said a few days ago that the company has published 9 research papers regarding the safety and effectiveness of the vaccine. On June 11, VK Paul, member (health) of NITI Aayog, had said that in the next 7-8 days, the data of the third phase of the trial of Covaccine will also be published.
Bharat Biotech said in a statement that India’s regulators have thoroughly reviewed all data from trials conducted in the first and second phases of the vaccine vaccine and partial data for the third phase. According to the statement, “The company has already published 9 research studies in the last 12 months in the globally reputed 5 best review journals on the safety and effectiveness of Covaccine for a timely and comprehensive review.”
Covaccine is involved in approval process in more than 60 countries
The company said on June 12 that the first and second phase trials of the vaccine vaccine were published in the famous journal ‘The Lancet’. Bharat Biotech said, “At present, data from the Phase III trial on the efficacy and safety of the vaccine is being analyzed and compiled. Along with this, it has been ensured that its purity is not compromised. The company will soon make public the data of Phase III trials.
After the data of the third phase comes out, the effective capacity of the vaccine against the corona virus will be known. Bharat Biotech said last month that it expects an emergency use approval (EAU) from the World Health Organization (WHO) for the vaccine by July-September. The company had said that regulatory approvals for Covaccine are in process in more than 60 countries, including countries like America, Brazil, Hungary.
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