GlobalHealth Threats

11 November: The interim results from a Phase 3 study of Bharat Biotech’s Covaxin vaccine (BBV152) have been published in The Lancet. As earlier reported by the company, the vaccine was found to be 77.8% effective against COVID-19 infection in the study of over 25,000 people in India. Vaccine efficacy against severe infection was 93.4%. Preliminary analysis has found efficacy of 65.2% against infection with the Delta variant, but the researchers state further investigations into efficacy against variants is needed.

There were no safety concerns nor any reports of anaphylaxis. The most common side effects reported were pain at the injection site, headache, fever and fatigue.

The vaccine was issued an Emergency Use Listing by the World Health Organization on 3 November.

8 June: A small study has found that Covaxin (BBV152) remains able to neutralise the Beta (B.1.351) and Delta (B.1.617.2) variants. The authors also state that since Covaxin is based on the whole inactivated virus, it has less chances of becoming ineffective against variants. The study is published on BioRxiv and is yet to be peer reviewed.

22 April: In addition, the Indian Council of Medical Research tweeted that COVAXIN works against several strains, including B.1.1.7 (first identified in the United Kingdom), B.1.1.28 (first identified in Brazil) and B.1.617 (the double mutant strain identified in India).

21 April: Bharat Biotech and ICMR have announced Interim Results from Phase 3 trials of COVAXIN® in a press release. This is the second interim analysis and is based on assessment of 87 symptomatic cases of COVID-19. These new results estimate vaccine efficacy of 78% against mild, moderate and severe COVID-19 disease. The efficacy against severe COVID-19 disease was 100% with an impact on reduction in hospitalizations. Final results will be available in June.

9 March: Findings from phase 2 trials and 3 month follow up of participants from Phase 1 have been published in The Lancet. Phase 2 trials included 356 participants between the ages of 12 and 65 years old who were vaccinated at days 0 and 28. The results demonstrate that COVAXIN is well tolerated and produces a sustained immune response at 3 months after the 2nd dose.

3 March: Bharat Biotech has announced that its Phase 3 interim results of the COVID-19 vaccine COVAXIN showed 81% efficacy after the second dose. Data from 25,800 participants between the ages of 19 and 98 also demonstrated that the vaccine was well tolerated. Bharat Biotech will continue to share further details of trial results as more data becomes available.