Bharat Biotech’s Covaxin set to go global after WHO gives it a booster

Hyderabad-based Bharat Biotech’s vaccine, Covaxin, received the much-awaited Emergency Use Listing (EUL) from the World Health Organization (WHO) on Wednesday, bringing relief to students, business travelers, and all those who intend to travel abroad.

The WHO decided to grant the EUL after a risk-benefit assessment of Covaxin for global use. The WHO said in a tweet: “WHO has granted emergency use listing (EUL) to Covaxin (developed by Bharat Biotech), adding to a growing portfolio of vaccines validated by WHO for the prevention of Covid-19.”

“This emergency use listing expands the availability of vaccines, the most effective medical tools we have to end the pandemic,” said Dr Mariangela Simao, WHO’s assistant-director general for Access to Medicines and Health Products.

This makes Covaxin the sixth vaccine to receive EUL after the Pfizer-BioNTech, AstraZeneca, Johnson & Johnson-Janssen, Moderna, and Sinopharm vaccines.

Reacting to the news, Krishna Ella, chairman and managing director of Bharat Biotech, said: “Validation by WHO is a very significant step towards ensuring global access to India’s widely administered, safe, and efficacious Covaxin. As an organisation, we have focused on maintaining stringent quality and safety standards that meet rigorous assessment, and scientific standards established by WHO, as a result, many of our vaccines have received WHO prequalification.”

Union Health Minister Mansukh Mandaviya took to twitter to thank the WHO, saying this was ‘Diwali’ for ‘Atmanirbhar Bharat’. “Thanking WHO for granting emergency use listing (EUL) to made-in-India Covaxin,” the minister said.

Covaxin had demonstrated 77.8 per cent efficacy against symptomatic Covid-19 infections and a 93.4 per cent efficacy against severe symptomatic infection.

India had thrown its weight behind locally-manufactured vaccines. Prime Minister Narendra Modi said at the G20 summit session in Rome on Saturday that it was necessary that the WHO approves Indian vaccines “at the earliest”.

Long journey

The journey to EUL status took longer than what the firm had expected. In May, Bharat Biotech had said that it expects the EUL between July and September. The firm had submitted all the necessary documents for the EUL on July 9.

However, even as recently as October 26, the WHO’s Technical Advisory Group (TAG) sought additional clarifications from Bharat Biotech. Rolling data submission to the WHO began on July 6, and the company has been providing additional data as and when it was sought.

Sources in India’s vaccine industry said, “Pfizer and Moderna got WHO EULs within six to nine weeks or so after they published their phase III clinical trial results. Bharat Biotech declared the results around July, and it’s been over 12 weeks or so. An inadequately drafted application can be a reason behind the back and forth between the company and the WHO.”

The person quoted above, who is a senior executive at a vaccine maker, also added that “back and forth” with queries is part of the normal approval process. “In some cases, it takes longer than usual. It is not a matter of concern,” he added.

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