According to Indian media reports, a team of experts from the Central Drug Standards Control Organization (CDSCO) of India has agreed to approve the emergency use authorization of the coronavirus vaccine developed by Bharat Biotech, known as Covaxin.
This may make it the second coronavirus vaccine to be licensed by the SEC in India after Covishield, the Oxford/AstraZeneca coronavirus vaccine.
According to the report, Covaxin is the first coronavirus vaccine developed in India. It is being developed by Hyderabad-based Bharat Biotechnology Co., Ltd. in cooperation with the Indian Medical Research Council (ICMR) and the National Institute of Virus Research of India (NIV).
India’s ANI News Network quoted government sources as saying that the Group of Experts has recommended the approval of the emergency use authorization of Covaxin. The proposal, as well as the method of promoting vaccination, is now referred to the Indian Drug Administration (DCGI) for final decision.
The Group agreed to the emergency use authorization of Covaxin the day after agreeing to approve the emergency use authorization of Covishield. CDSCO’s expert group previously requested Bharat Biotechnology to submit data on Covaxin and recommended accelerating the recruitment of volunteers for ongoing phase 3 clinical trials.
The expert group previously recommended that the company could conduct a medium-term efficacy analysis to further consider the use of Covaxin restricted emergency use licenses.
Bharat Biotechnology has reportedly submitted interim data for phase 1 and phase 2 clinical trials, as well as unpeer-reviewed safety and immunogenic data in journals. However, the company has not disclosed the results of phase 3 clinical trials or research plans.
Krihsna Ella, president of Bharat Biotechnology, said that the Covaxin vaccine is effective against the more infectious B.1.1.7 mutant COVID-19 strain reported in the UK last month, because the inactivated vaccine contains two types that can cope with mutation.
Ingredients of heterotoxic strains. To date, except for the United Kingdom, this variant of the novel coronavirus has been found in India, Denmark, the Netherlands, Australia, Italy, Sweden, France, Spain, Switzerland, Germany, Canada, Japan, Lebanon and Singapore.
As we prepare for the launch of the two coronavirus vaccines, India has conducted a nationwide simulation exercise for vaccination efforts, which aim to test the vaccine delivery network and the accompanying digital platform Co-WIN, and also check the preparedness to deal with possible adverse reactions after vaccination.
According to the data released by the Ministry of Health of India at 8 a.m. local time on the 2nd, the cumulative number of confirmed cases of COVID-19 in India reached 1,0305,788, with a total of 149,218 deaths.