Covaxin, Vaccine Developed in India, Gets W.H.O. Clearance

The vaccine is the eighth coronavirus vaccine to receive the global health body’s green light.

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The W.H.O. grants Covaxin, a Covid vaccine developed in India, emergency authorization.

A health worker administered a dose of the Covaxin coronavirus vaccine at a health center in Garia, India, last month.Credit…Bikas Das/Associated Press

Nov. 3, 2021, 12:36 p.m. ET

The World Health Organization on Wednesday granted emergency authorization to Covaxin, the first coronavirus vaccine developed in India and to get the designation, providing a major boost for Prime Minister Narendra Modi, who has stressed his intention of making the country’s pandemic prevention effort self-reliant.

The vaccine was developed by Bharat Biotech, an Indian drug company, and the Indian Council of Medical Research, a government body, and is the eighth coronavirus vaccine to receive the global health body’s green light.

The W.H.O. said in a tweet that Covaxin met standards for protection against Covid-19 and that the benefit of the vaccine far outweighs the risks.

Mr. Modi’s government was already exporting the vaccine to gain favors in a geopolitical struggle with China, which has used its large infrastructure projects to bolster its image.

The W.H.O. said Covaxin had a 78 percent efficacy rate against Covid-19 and should be administered in two doses four weeks apart to adults, noting the vaccine’s easier storage requirements might be convenient for poor and developing countries.

On Wednesday, India’s top drug regulatory authority said that it was extending the shelf life of Covaxin from 6 to 12 months from the date of manufacture, based on data showing that it is safe and effective.

Mr. Modi, who got his first shot of the vaccine in March, said at the Group of 20 summit in Rome last week that his country will be able to produce over five billion vaccine doses overall next year to help the world in the fight against the pandemic.

Covaxin was approved by Indian government officials in January and administered to millions of people even without data being released. Many in the country, including frontline health care workers, had feared that Covaxin could be ineffective or worse, slowing down the national campaign to inoculate 1.3 billion people.

Officials in Brazil, where the government had bought doses of Covaxin, had raised questions about the vaccine and were investigating possible irregularities in its contract to buy 20 million shots of Covaxin from India.

Covaxin is being manufactured in three different locations in India, with the current production at over 50 million doses per month. The company has said it is aiming to make 1 billion doses per year by the end of this year.

The W.H.O.’s sign-off comes after a lengthy review period; the manufacturers applied in April and provided the first batch of data to the agency on July 6, addressing a host of issues, including the vaccine safety and efficacy.

Covaxin’s manufacturers said in a statement on Wednesday that the W.H.O.’s validation would help expedite requests from countries seeking to buy the vaccine.

Dr. Krishna Ella, a top official at Bharat Biotech, said that the organization has focused on maintaining stringent quality and safety standards.

The authorization “will enable us to contribute to accelerating the equitable access of Covid-19 vaccine, and the access to our vaccine globally,” he said.

Worldwide, about 75 percent of all Covid shots have been administered in high- and upper-middle-income countries, according to the Our World in Data project at the University of Oxford. Only 0.6 percent of doses have been administered in low-income countries.

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