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Data Show India's Homegrown COVID-19 Vaccine Works — 2 Months After It Was Approved

By Lauren Frayer

Published March 4, 2021 at 8:48 AM CST

It turns out a COVID-19 vaccine that stirred controversy in India may be effective after all.

The Indian government approved the use of the COVAXIN vaccine, made by the Indian company Bharat Biotech, on Jan. 3 – while clinical trials were ongoing, and before efficacy data was out. Scientists, public health experts and opposition politicians expressed concern.

Many called the move premature. Some accused India of acting out of nationalism. The Bharat Biotech formula has been billed as India's first "indigenous" vaccine.

Critics cautioned India to wait for data from phase 3 clinical trials.

Now, that data is out.

Late Wednesday, Bharat Biotech released interim data showing its vaccine prevents COVID-19 in 81% of patients who receive two doses. The phase 3 clinical trial involved 25,800 subjects, making it the largest ever in India, the company said.

Trials are still ongoing, and further data is needed for a "final analysis," it said. But Bharat Biotech's chairman said this interim data "demonstrates high clinical efficacy."

"Today is an important milestone in vaccine discovery, for science and our fight against coronavirus," Dr. Krishna Ella said in a statement. He added that the vaccine also shows "significant immunogenicity against the rapidly emerging variants."

The Indian Council of Medical Research, which collaborated with Bharat Biotech, issued its own statement saying the interim results had been evaluated by an independent data safety and monitoring board.

The interim results are "a testament to India's emergence as a global vaccine superpower," said Dr. Balram Bhargava, the ICMR's director general.

India is already the world's biggest vaccine producer. It has approved two vaccines so far: Bharat Biotech's, and the Oxford-AstraZeneca formula. Both are being manufactured inside India, and both require two shots.

When Prime Minister Narendra Modi got his first vaccine dose Monday, it was the Bharat Biotech formula.

Officials in India hope the company's interim results boost faith in the government's vaccination program. It aims to inoculate 300 million people by July, but is not on track to meet that target.

Bharat Biotech says "more than 40 countries" have expressed interest in its vaccine.