British medical journal the Lancet recently released a study on made-in-India Bharat Biotech’s Covaxin and said that the vaccine doses were well tolerated and no vaccine-related serious adverse events were found.
The study was, however, conducted during the phase 1 trial of the vaccine. The first face of the trial of Bharat Biotech’s Covaxin was conducted during the lockdown and with 375 participants. The report said that the fact that the daily number of cases back then were high, people 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.
The test in phase 1 was conducted at 11 hospitals across India and the second vaccine dose for administered 14 days apart.
Post-vaccination, people were tracked for 2 hours. There were also asked to report local and systemic reactions for the upcoming seven days. The overall incidence of solicited local and systemic adverse events in this study was 14–21% in all vaccine-treated groups, the Lancet report says.
“The results reported here do not permit efficacy assessments. The analysis of safety outcomes requires more extensive phase 2 and 3 clinical trials,” it added.
Currently, the Drug Controller General of India has approved Covaxin for restricted emergency use. A person to whom the vaccine is being given has to give his consent and only after his/her consent the vaccine would be administered to them.