India’s homegrown Covid-19 vaccine Covaxin has an efficacy rate of more than 93.4% against severe Covid-19 infection and 77.8% against symptomatic infection, according to data released Saturday by the shot’s developer.
Pharmaceutical company Bharat Biotech announced it had concluded the final analysis of its Phase 3 clinical trials, which it called the largest Covid-19 vaccine trial in India.
The trial involved 25,800 participants aged 18 to 98. Of those, 2,433 people were over 60 years old, and 4,500 had comorbidities.
Bharat Biotech said the results found Covaxin provided 65.2% protection against the Delta variant, which was first detected in India and is the dominant variant in the country.
The efficacy data has been published online in MedRxiv, a site where studies can be published without being peer reviewed.
Bharat Biotech’s chairman and managing director Dr. Krishna Ella said the result “establishes the ability of India and developing world countries to focus towards innovation.”
“Covaxin will not only benefit the Indian citizens but would also immensely contribute to protect the global community against the deadly (Covid-19),” said Balram Bhargava, the director general of Indian Council of Medical Research (ICMR), which co-developed the vaccine.
The two-dose Covaxin shot was approved for restricted emergency use in India in January, before preliminary results from the Phase 3 trial were released. It has received emergency use authorization in 16 countries including Brazil, the Philippines, Iran and Mexico, according to the company.
Hyderabad-based Bharat Biotech is holding talks with the World Health Organization (WHO) to receive emergency use authorization for its shot.
If it does, Covaxin would be the first Indian-developed vaccine to receive WHO authorization.
Bharat Biotech has faced controversy over the vaccine in the past. Earlier this year, more than a dozen Phase 3 trial participants in slum areas of the Indian city of Bhopal told CNN they didn’t realize they were part of a clinical trial — instead, they thought they were being vaccinated.
Bharat Biotech, ICMR, and People’s Hospital in Bhopal, which ran the trial, have denied wrongdoing.
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