By Manojna Maddipatla
(Reuters) – The coronavirus vaccine from Indian drugmaker Bharat Biotech, which has been approved for use in the country, appears to be safe and elicits an immune response in a small group of adults aged 18 to 55, according to a study conducted in the medical journal The Lancet was published.
The vaccine, developed in collaboration with the Indian Medical Research Council (ICMR), is being evaluated in a separate trial of 25,800 people that began in November. Bharat Biotech said on Friday that 13,000 people taking part in the late trial had received the second dose.
The interim data published in the journal https://www.thelancet.com/journals/laninf/article/PIIS1473-3099(20)30942-7/fulltext 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 further efficacy trials are warranted, the report said.
COVAXIN is an inactivated vaccine that introduces dead viruses into the body to elicit an immune response.
This is the first peer-reviewed data for the vaccine that has been scrutinized after much criticism over the lack of transparency over the approval process for the shot.
The vaccine was approved this month by India’s Drug Administration, 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, began its own vaccination process on Saturday in what the government calls 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)