Bharat Biotech's Covaxin led to enhanced immune responses, says Lancet
British medical journal the Lancet has published a study on the effects of Bharat Biotech's Covaxin, the indigenous vaccine against Covid-19, and said the vaccine doses were well tolerated and no vaccine-related serious adverse events were found. The study, funded by Bharat Biotech International, was conducted during the phase 1 trial of the vaccine. Though Bharat Biotech funded the study, the funder had no role in data collection, data analysis data interpretation or writing of the report, but was involved in study design, the Lancet report says.
The study was conducted during the lockdown and around 375 participants were enrolled for the purpose between July 13 and 30. The study also notes that since the number of daily infections was high at that time, participants were more exposed to the virus. "The sample size was intentionally large to enable the inference of meaningful conclusions regarding neutralising responses. With several reports questioning the efficacy of SARS-CoV-2 vaccines against antigenically divergent strains, we report neutralising responses to homologous and heterologous strains," the report said.
This trial was held at 11 hospitals across India and the doses were administered 14 days apart, not 28 days as what will be done to vaccine recipients.
The participants were divided into several groups and all reported enhanced immune responses, the report said.
Participants were observed for two hours after the trial to assess reactogenicity and were also instructed to record local and systemic reactions within seven days (after each dose). The overall incidence of solicited local and systemic adverse events in this study was 14–21% in all vaccine-treated groups.
"The results reported here do not permit efficacy assessments. The analysis of safety outcomes requires more extensive phase 2 and 3 clinical trials," it said.
The Drug Controller General of India granted restricted emergency use authorisation to Bharat Biotech's Covaxin under the clinical trial mode, which entails taking consent from the beneficiaries before administering them with the doses, and then following up on each beneficiary.
From January 16 onwards, healthcare workers of the country are being administered vaccines — both Covaxin and Serum Institute of India's Covishield.
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