Bharat Biotech’s COVID-19 fired safely, produced an immune response at the start of human testing

By Manojna Maddipatla

(Reuters) – The coronavirus vaccine by Indian pharmaceutical company Bharat Biotech, which has been authorized for use in the country, has proved safe and produced an immune response in a small group of adults aged 18 to 55, according to a study published in the The Lancet medical journal.

The vaccine, developed with the Indian Medical Research Council (ICMR), is being evaluated in a separate test of 25,800 people, which began in November. Bharat Biotech said on Friday that 13,000 people who participated in the last stage of the study received the second dose.

Provisional data published https://www.thelancet.com/journals/laninf/article/PIIS1473-3099(20)30942-7/fulltext in the journal included three different vaccine formulations and a placebo group among 375 adults.

Two formulations of the vaccine, called COVAXIN, have been selected for more advanced stages of testing and more tests of effectiveness are warranted, the report said.

COVAXIN is an inactivated vaccine that introduces dead viruses into the body to trigger an immune response.

This is the first peer-reviewed data for the vaccine that has been examined after widespread criticism of the lack of transparency in the vaccine approval process.

The vaccine was granted emergency approval by India’s general drug controller this month, along with another vaccine, Covishield, developed by AstraZeneca and the University of Oxford.

India, which reported the highest number of coronavirus infections after the United States, started its own vaccination campaign on Saturday, in what the government called “the world’s largest vaccination program”.

(Reporting by Manojna Maddipatla in Bengaluru, additional reporting by Ankur Banerjee and Julie Steenhuysen; Editing by Caroline Humer in New York and Sriraj Kalluvila)

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