By Mark Bennett, Worthy News Correspondent
(Worthy News) – Bharat Biotech is now approved for human trials, and slated to start human vaccine testing for COVID-19 in July. It will be India’s first domestic pharmaceutical candidate to receive the go-ahead from the government’s drug regulator as cases are sky-rocketing in the 1.3 billion population.
According to a company statement released this past Monday, the (DCGI) Drug Controller General of India told Bharat Biotech to begin Phase I and II clinical trials of their new vaccine, COVAXIN, which was developed along with the Indian Council of Medical Research’s National Institute of Virology.
COVAXIN was developed and manufactured in Bharat Biotech’s facility at Genome Valley in Hyderabad, India. According to the Ministry of Health, India is just behind the United States, Brazil, and Russia in total cases, and reported close to 20,000 new infections this past Monday, June 29th.
According to Krishna Ella, CMD of Bharat Biotech, COVAXIN will be the first indigenous vaccine developed specifically for COVID-19. The vaccine was tested in animals utilizing schedule Y and WHO guidelines. The reports showed the vaccine was safe and immunogenic in all animal cases. Thus, the DCG said clinical testing can now begin on humans.
Moreover, Bharat Biotech is also working jointly with the University of Wisconsin, at Madison to develop a nasal vaccine, CoroFlu, as well as leading another project for the development of a monoclonal antibody therapy for COVID infections. Bharat Biotech has over 140 global patents and has developed more than 16 vaccines.
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