Covaxin Phase I data gets good reviews in Lancet, journal says ‘it led to enhance immune response’

New Delhi: Even as the controversy rages over Covaxin, India’s first indigenous Covid-19 vaccine, a renowned medical journal Lancet has given thumbs up to the vaccine saying that it led to enhanced immune response without any side effects.

Lancet, which published the Phase I results of Covaxin in its latest edition said, “BBV152 led to tolerable safety outcomes and enhanced immune responses. The vaccine was well tolerated in all dose groups with no vaccine-related serious adverse events.”

Developed by Bharat Biotech in collaboration with the Indian Council of Medical Research (ICMR) and the National Institute of Virology (NIV), Pune, the vaccine was granted emergency use authorisation in clinical trial mode’ by the Indian government.

Covaxin, which is now undergoing phase-3 trials, had raised concerns among experts over its emergency approval earlier this month by India’s drug regulator.

The vaccine, codenamed BBV152, was well tolerated in all dose groups with no vaccine-related serious adverse events, noted the authors of the study funded by Bharat Biotech. The same results were earlier published in the preprint server medRxiv in December.

The most common adverse event was pain at the injection site, followed by headache, fatigue, and fever. Overall, the side effects including those near the injection site (e.g. redness and swelling) and others that were system-wide (e.g. fever) were experienced by 1 in 5 or 1 in 6 people that were given the vaccine. These side effects, researchers said in the study, were much lower than for other SARS-CoV-2 vaccine candidates.

Covaxin is an inactivated vaccine developed by chemically treating novel coronavirus samples to make them incapable of reproduction.