Bharat Biotech Covaxin Safe, Generates Immune Response Against COVID-19: Study Published In British Medical Journal Lancet

A study by multiple researchers, including Raches Ella, MBBS and Krishna Mohan Vadrevu, PhD of Bharat Biotech, Hyderabad over the COVID-19 vaccine, Covaxin, has been published in British Medical Journal Lancet.

The study has found that Bharat Biotech's Covid-19 vaccine, Covaxin, is safe and generated immune response in the participants of the vaccine's phase-1 trials.

The paper published in the medical journal said that the vaccine generated tolerable safety outcomes and enhanced immune responses.

According to the study, all adverse events were mild and moderate and were more frequent after the first dose.

It said that one adverse event was reported but was unrelated to the vaccine.

Between 13 and 30 July 2020, 827 participants were screened, of whom 375 were enrolled. Among the enrolled participants, 100 each were randomly assigned to the three vaccine groups, and 75 were randomly assigned to the control group.

"The most common solicited adverse events were injection site pain , headache , fatigue, fever, and nausea or vomiting," the journal said.

"All solicited adverse events were mild (43 [69%] of 62) or moderate (19 [31%]) and were more frequent after the first dose. One serious adverse event of viral pneumonitis was reported in the 6 μg with Algel group, unrelated to the vaccine," it said.

It should be noted that Bharat Biotech developed the Covaxin in collaboration with the Indian Council of Medical Research (ICMR) and the vaccine is currently being used in India's Covid-19 immunisation drive after getting DCGI nod for emergency use.