Shot in the arm: Covaxin’s 81% effective, works against UK variant
The first interim review of Phase-3 trials for Bharat Biotech’s Covid-19 vaccine Covaxin has revealed 81% efficacy, the company announced on Wednesday. It added that “analysis from the National Institute of Virology indicates that vaccine-induced antibodies can neutralise the UK variant strains and other heterologous strains”.
Now, Covaxin was approved for restricted use in an emergency situation by the Drug Controller General of India on January 3. However, since Bharat Biotech had not finished recruiting and vaccinating enough participants for Phase 3 trials, the approval was without efficacy data.
The company said its initial analysis was based on 43 trial participants getting coronavirus, of whom 36 had not received the vaccine. The interim analysis also showed that severe, serious, and medically attended adverse events occurred at low levels and were balanced between vaccine and placebo groups, it added.
Bharat Biotech also said it planned further interim analysis for 87 cases and a final analysis for 130. This data has yet to be peer-reviewed.
The Phase 3 trial results are significant since the company had approached the Central Drugs Standard Control Organisation for approval to conduct late-stage clinical trials of Covaxin in children aged between 5 to 18.
Till now, the vaccine has been administered to healthcare and frontline workers “in clinical trial mode” as part of the government’s mass Covid-19 vaccination campaign.