Bharat Biotech’s Covaxin safe, induced immune response in Phase-1: Lancet
Phase-1 interim data published in the British medical journal Lancet has found India’s indigenous vaccine Covaxin by Bharat Biotech to produce and immune response and be well-tolerated.
The vaccine maker’s Joint Managing Director, Suchitra Ella, tweeted about the publication as the first publication from India about a coronavirus vaccine’s clinical trial. She assured that the company’s work in India would be maintained on par with global standards. She also mentioned that Phase-3 trials of the vaccine saw 13,000 volunteers vaccinated with the 2nd dose.
In the wake of backing out of taking the vaccine by some frontline workers (including doctors), this publication comes as a timely report for the Hyderabad-based company. The vaccine, now undergoing Phase 3 trials, was developed in collaboration with the NIV (National Institute of Virology) and ICMR (Indian Council of Medical Research). Phase 2 results to report Bharat’s Biotech’s Covaxin safe are being analyzed.
Phase 1 assessments to test the potential adverse effects and safety were conducted in July 2020. The trials that tested the immune response conferred b the vaccine saw 375 volunteers between 18 and 55. While 14-21% was the total systemic adverse events, the most common side effect was pain at the vaccine injection site, followed by fever, fatigue, and headache.
The vaccine maker maintained that these adverse events’ occurrence was significantly lower than those for other COVID-19 vaccine candidates. The reports said that while there was just 1 serious viral pneumonitis event, 31% percent of the adverse events were moderate, and 69% were mild. The study states that the vaccine has induced antibody responses that are neutralizing and binding. 14 days after the 2nd dose (or after 28 days), all the vaccinated individuals demonstrated neutralizing antibodies and spike-binding antibodies noticeably elevated in number. Followed this, the clinical trials reported Bharat Biotech’s Covaxin safe.
The Government has approved the vaccine for restricted emergency use under clinical trial mode. They have acquired 55 million vaccine doses.