The trials for the third phase of the vaccine involved 25,800 subjects and it was the largest ever conducted in India.
The Indian Council of Medical Research (ICMR) has said that the indigenously made vaccine Covaxin has shown an interim efficacy of 81% during the phase 3 results.
What does ‘efficacy’ of a vaccine mean?
The efficacy of a vaccine represents how much it prevents against a pathogen in comparison to the absence of vaccination. The measures the ability of a vaccine to protest an individual from a disease based on certain parameters.
In the case of Covaxin, the 81% efficacy means that the vaccine was able to fight the coronavirus in 81% of people who received it during the trial.
Notably, trials for the third phase of the vaccine, which has been jointly developed by ICMR and Hyderabad-based Biotech International Limited (BBIL), were started in November last year. The trials involved 25,800 subjects, the largest ever conducted in India.
"The bench-to-bedside journey of completely indigenous COVID-19 vaccine in less than eight months` time showcases the immense strength of Atmanirbhar Bharat to fight the odds and stand tall in the global public health community. It is also a testament to India`s emergence as a global vaccine superpower," said Dr Balram Bhargava, Director General, ICMR.
"Covaxin demonstrates high clinical efficacy trend against Covid-19 but also significant immunogenicity against the rapidly emerging variants," said Dr Krishna Ella, Chairman and Managing Director, Bharat Biotech.
Covaxin is one of two COVID-19 vaccines that was granted emergency use approval in the country in early January. The DCGI in early January gave permission to Covaxin "for restricted use in an emergency situation." However, a huge backlash followed the announcement as the vaccine had yet not completed phase three trials.
Bharat Biotech expects to share further details of the trial results as additional data become available. Additional interim analysis is planned for 87 cases, and the final analysis is planned for 130 cases. All data from the second interim and final analyses will be shared via pre-publication servers as well as submitted to a peer-reviewed journal for publication, Bharat Biotech said.
In the case of Covid-19 vaccines, pharma companies have primarily focussed on bringing down the number of symptomatic cases — even if you’re infected with SARS-CoV-2, you may not present with the symptoms and fall as sick as you would have without the vaccine.
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