India's Bharat Biotech has finally published the Phase III results of its COVID-19 vaccine Covaxin which it produced in collaboration with the Indian Council of Medical Research and the National Institute of Virology. The paper published in the medical journal Lancet shares that the vaccine is 78 per cent effective against SARS-CoV-2, the virus that causes COVID-19.
The paper also shares that the vaccine is 65.2 per cent effective against the delta variant of the virus. This is the same variant that was first found in India but was later responsible for the surge in cases across the world.
The published data comes after several questions were raised on the delay in presenting the results of the vaccine's clinical trials. In the case of other vaccines, emergency approvals were only given after their results were publicly shared and published. India's regulatory body approved the vaccine for emergency use authorisation in January 2021 when its Phase III trials were still ongoing.
This paper also comes a week after Covaxin received emergency use listing by the World Health Organisation.
The Hyderabad- based manufacturer has produced over 150 million doses of the vaccine and has said that it will meet its annual capacity of 1 billion doses.
With close to 25,000 participants in the phase III trial, the trials for the vaccine were the largest in India. The vaccine is currently being evaluated for children between the ages of 2-18 in the country.
In the trials only 24 people from the 8471 who received the vaccine developed COVID-19 indicating that the vaccine has a 77.8 per cent efficacy. While the manufacturer had earlier shared this finding, the detailed data is only available now.
Bharat Biotech used the services of health consulting firm IQVIA to assess any adverse events and the onset of COVID-19 symptoms across the country. Those who developed COVID-19 were followed up daily through telephonic conversations to assess the severity of symptoms until they were either resolved or the patient required hospitalisation for severe COVID-19. If the latter did occur, it was recognised as a severe adverse event.
From the close to 12,000 participants in the vaccine arm, over 230 discontinued at various stages of the trial. This number was 220 in the placebo arm.
The manufacturer has also shared the vaccine's effectiveness against the variants of concern and the variants of interest. Covaxin's efficacy against severe symptomatic COVID-19 stands at 93 per cent. While it is 65 per cent effective against the Delta variant, it is close to 90 per cent effective against the kappa variant.