'Covaxin Doses Were Well Tolerated, No Serious Adverse Effects Were Found,' Says Lancet Report

A study on the effects of India's first indigenous vaccine against Coronavirus developed by Bharat Biotech, 'Covaxin', has been published by the reputed British medical journal, The Lancet saying that the vaccine doses were well tolerated, and no vaccine-related serious adverse effects were found.

Covaxin is being developed by Bharat Biotech in association with the Indian Council for Medical Research and the National Institute for Virology, Pune.

Suchitra Ella, joint managing director of Bharat Biotech, said, "With this, Covaxin become the first COVID-19 vaccine from India to have its data published in the lancet," reported Times of India.

The Lancet said that the study for the vaccine was conducted during the phase 1 trial of the vaccine and it was funded by Bharat Biotech International. It was also clarified by the journal that the funder had no role in data collection, data analysis, data interpretation or writing the report but was involved in study design.

The British journal in its report said, "Covaxin induced binding and neutralising antibody responses and with the inclusion of Algel-IMDG adjuvant. BBV152(codename for Covaxin) is the first inactivated SARS-CoV-2 vaccine that has been reported to induce a Th1-biased response."

"There is no vaccine-related serious adverse events and the sole serious adverse event was not causally associated with the vaccine. The vaccine was well tolerated in all dose groups," the Journal reported.

Giving data of the number of people on which the trial was conducted to study, Lancet report said that 875 individuals were screened and out of them, 375 were enrolled and first 50 participants were monitored for 7 days after vaccination.

"On the basis of the independent data safety monitoring board review of masked safety data, the trial was allowed to continue with an enrolment of the remaining participants into all groups. Among the enrolled participants, 100 each were randomly assigned to the three vaccine groups, and 75 were randomly assigned to the control group (Algel only). Demographic characteristics of the participants were similar across groups," the British journal said.

Earlier, when Covaxin was approved for the emergency use by the government, it was highly criticized because its efficacy data was not available in the public domain.

The Lancet report also said that all the adverse events observed in the Phase 1 trials were mild or moderate and were more frequent after the first dose than the second and no significant differences were observed between the vaccinated and control groups.

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