Bharat Biotech's Covaxin led to 'enhanced immune responses' in phase 1 trials, says Lancet

Updated : January 22, 2021 04:06 PM IST

The report was an interim one and does not determine the long-term safety outcomes or efficacy of the vaccine

On January 3, Covaxin became the country’s first indigenously produced vaccine against COVID-19 to get ‘restricted emergency approval’.

An interim report published in British medical journal The Lancet on January 21 on Covaxin’s phase 1 trials stated that the vaccine led to “tolerable safety outcomes” and “enhanced immune responses”. The report was an interim one and does not determine the long-term safety outcomes or efficacy of India’s first indigenous COVID-19 vaccine candidate.

The report stated: “We did a double-blind, multicentre, randomised, controlled phase 1 trial to assess the safety and immunogenicity of BBV152 (Covaxin) at 11 hospitals across India.” Healthy individuals between 18 and 55 years were included in the study, for which 827 participants were screened between July 13 and July 30 last year. Of these, 375 were enrolled.

The findings from the trial are important, as there has been growing hesitancy among many people across India to take the vaccine shot, since the drive was launched on January 16. The hesitancy has been especially towards Bharat Biotech's Covaxin, as it’s still undergoing phase 3 trials.

The most common adverse event was “injection site pain” (in 5 per cent of the participants), followed by headache and fatigue (3 per cent each), and fever and nausea or vomiting (2 per cent each). “All solicited adverse events were mild or moderate and were more frequent after the first dose,” stated the report. The only serious adverse event was “viral pneumonitis”, which, the report states, was “unrelated to the vaccine”.

These are interim results and do not indicate long-term safety or antibody responses. They also cannot help assess the efficacy of the vaccine, necessitating phase 3 trials.

On January 3, Covaxin became the country’s first indigenously produced vaccine against COVID-19 to get ‘restricted emergency approval’. The government had declared that those receiving Covaxin — developed by pharma major Bharat Biotech in collaboration with Indian Council of Medical Research (ICMR) and National Institute of Virology (NIV) — would be monitored the same way as volunteers are in clinical trials. The approval created a huge furore, with several experts raising questions due to lack of sufficient safety or efficacy data from large-scale trials.

Published : January 22, 2021 04:06 PM IST

Bharat Biotech's Covaxin led to 'enhanced immune responses' in phase 1 trials, says Lancet

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