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Covaxin, the coronavirus vaccine from Bharat Biotech, now under restricted emergency use, has been found to be well-tolerated and produced an immune response, as per the findings of the Phase-1 interim data published by the company in British medical journal Lancet .
Suchitra Ella, Joint Managing Director, Bharat Biotech, tweeted, “ …. phase I clinical trial studies of Covaxin published in the British Journal The Lancet Infectious diseases. This is the first clinical trial publication on a Covid-19 vaccine from India. We continue in this journey of bringing you work that is made in India on par with International standard.”
She tweeted “13,000 volunteers have been successfully administered the second dose in the Phase-3 clinical trials of Covaxin.”
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Study findings
For the Hyderabad-based vaccine maker, these findings are timely in the backdrop of reports of some front line workers, including doctors, reportedly backing out from taking the indigenously developed vaccine. Covaxin, developed by Bharat Biotech in collaboration with the Indian Council of Medical Research and National Institute of Virology, is now undergoing phase-3 trials and the data from Phase 2 trials is under analysis.
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In Phase-1, during July 2020, Bharat Biotech enrolled 375 people aged between 18 and 55 years of age to assess the safety and potential side-effects of the vaccine and the immune response to fight an infection. As per the study, the most common adverse event was pain at the injection site, followed by headache, fatigue and fever. And the overall systemic adverse events was 14–21 per cent.
The company maintained that the incidence of adverse events was noticeably lower than the rates for other SARS-CoV-2 vaccine platform candidates.
As per the report, 69 per cent were mild and 31 per cent moderate and one serious adverse event of viral pneumonitis was reported.
According to the study, Covaxin has induced binding and neutralising antibody responses. After 28 days, that is 14 days after the second dose, all vaccinated had significantly elevated spike binding antibodies and neutralising antibody.
The Government had approved Covaxin for restricted emergency use under clinical trial mode and has procured 55 million doses of the vaccine. .
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