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It turns out that the controversy against COVID-19, which is causing controversy in India, may still be effective.
The Indian government approved the use of the COVAXIN vaccine, made by the Indian company Bharat Biotech, on January 3 – while clinical trials are underway and before efficacy data are released. Scientists, public health experts and opposition politicians have expressed concern.
Many called the move premature. Some have accused India of acting outside of nationalism. The Bharat Biotech formula has been announced as the first “local” vaccine in India.
Critics have warned India to wait for data from phase 3 clinical trials.
Now this data is exhausted.
Late Wednesday, Bharat Biotech published interim data showing that the vaccine prevented COVID-19 in 81% of patients receiving two doses. The phase 3 clinical trial involved 25,800 subjects, making it the largest in India, the company said.
Tests are still ongoing and additional data are needed for a “final analysis”, it said. But Bharat Biotech chairman said the interim data “showed high clinical efficacy”.
“Today is an important milestone in the discovery of vaccines for science and our fight against the coronavirus,” Dr. Krishna Ella said in a statement. He added that the vaccine also showed “significant immunogenicity against rapidly emerging variants”.
The Indian Medical Research Council, which is collaborating with Bharat Biotech, issued its own statement saying the interim results were evaluated by an independent safety and data monitoring council.
The interim results are “evidence of India’s emergence as a global vaccine superpower,” said Dr. Balram Bhargava, ICMR’s director general.
India is already the world’s largest producer of vaccines. So far, she has approved two vaccines: Bharat Biotech and the Oxford-AstraZeneca formula. Both are made in India and both require two shots.
When Prime Minister Narendra Modi received her first dose of vaccine on Monday, it was the Bharat Biotech formula.
Officials in India hope the company’s interim results will boost faith in the government’s vaccination program. Its goal is to inoculate 300 million people by July, but it is not on track to achieve that goal.
Bharat Biotech says “more than 40 countries” have expressed interest in its vaccine.