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The WHO grants emergency-use approval to India’s Covaxin

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The World Health Organization (WHO) has granted emergency use listing (EUL) to Covaxin, India’s homegrown covid-19 vaccine.

The inactivated virus vaccine was developed by Bharat Biotech in partnership with the government-administered Indian Council for Medical Research.

The Hyderabad-based company had applied for the EUL on May 24 and began submitting rolling data on safety and efficacy on July 6.

Since then, the WHO has met several times, most recently on Oct. 26, and regularly sought more data. The final approval has come after a meeting of the global health body’s technical advisory group held on November 3 following a risk-benefit analysis of adding Covaxin to the global vaccine basket.

A WHO approval has at least two immediate benefits: First, being on the EUL is that the India-developed vaccine can participate in the Covax initiative. Bharat Biotech is eligible to be enlisted as a supplier for the global vaccine-sharing initiative, which will allow India to donate and sell doses across the world.

The second is international travel.

In March this year, the Minister of Health Kailesh Jagutpal revealed in Parliament that Mauritius bought a dose of Covaxin for $15, while it was sold $3.40 in India.

He had also revealed that his ministry submitted an emergency use authorization and a
purchase order for the purchase of one million doses of Covaxin.

Covaxin was at the heart of a corruption scandal in Brazil, which led to an inquiry into Bharat Biotech’s $324 million contract with the Jair Bolsonaro government.

In June, Brazilian whistleblower Luis Ricardo Miranda alleged he was being pressured by an aide of the country’s health minister to clear a $45 million payment to Madison Biotech. Miranda was the head of medical imports in the ministry. The company was not listed in the original contract, but it later came to light that it was a partner of Bharat Biotech in Singapore.

An inquiry was launched on June 24. Eventually, the Bharat Biotech deal was suspended.

The vaccine maker denied any wrongdoing, despite additional allegations of a $200,000 payout to lobbyists. Company co-founder Suchitra Ella, along with Precisa Medicamentos, its Brazil partner, were part of the India-Brazil Chamber of Commerce (IBCC). It was found that the Brazilian entity had transferred $200,000 to the IBCC in two instalments in February.

Bharat Biotech has since severed its ties with Precisa Medicamentos.

Source: Quartz India and Defi Media

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