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Bharat Biotech's Covaxin Deal With Brazil Fell Apart In Just Three Weeks. What Went Wrong?

Bharat Biotech is pursuing approvals in various countries as per legal requirements applicable in each country.

Bharat Biotech is pursuing approvals in various countries as per legal requirements applicable in each country.

The cancellation of the MoU left Bharat Biotech without a formal representative in Brazil, subsequently complicating matters over the EUA.

The Brazil government cancelled the request for emergency use authorisation (EUA) of Bharat Biotech’s Covaxin, India’s first indigenous vaccine, on July 24. Following allegations of corruption and discrepancies in the company’s $320 million contract with Brazil, the Hyderabad-based pharma company terminated its Memorandum of Understanding (MoU), signed in November 2020, with Brazilian intermediaries Precisa Medicamentos and Envixia Pharmaceuticals. The company also stated at the time that it would work on obtaining all necessary approvals for the use of Covaxin in Brazil.

However, the cancellation of the MoU left Bharat Biotech without a formal representative in Brazil, subsequently complicating matters over the EUA, as per local Brazilian reports, and in just three weeks, the deal came crumbling.

So what happened in the three weeks that led to the termination of the contract?

End of June

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On June 25, head of imports at the Health Ministry Luis Ricardo Miranda, and his brother, Congressman Luis Miranda, turned whistleblowers and reported to the parliamentary committee that they received unusual pressure from the higher-ups for the purchase of Covaxin. They also added that no action was taken despite flagging the issue with President Jair Bolsonaro in March.

The same day, Bolsonaro claimed there was no irregularities or overpricing in the Covaxin contract, while some raised questions on the reason the government sealed an agreement with Bharat Biotech when the US from Pfizer offered its vaccine at a lesser price.

Four days later, on June 29, Brazil suspended its contract with Bharat Biotech, worth $321 million, to procure 20 million Covaxin doses. Bolsonaro also fired health ministry logistics chief Roberto Ferreira Dias, who allegedly asked for a bribe in a coronavirus vaccine deal.

On June 30, Bharat Biotech denied any malpractice in the Brazil-Covaxin deal and said it neither received any advance payments nor supplied any vaccines to Brazil’s health ministry. The company added that Covaxin was offered to Brazil at US$ 15 per dose.

Beginning of July

On July 5, Bharat Biotech altered its 29 June statement, which claimed “EUA received on 04 June 2021”. It clarified that on June 4 the country’s health regulator Anvisa (Agencia Nacional de Vigilancia Sanitaria) authorised exceptional import of Covaxin by Ministry of Health for distribution and use Under Controlled Conditions.

End of July

On July 23, Bharat Biotech terminated the MoU with Precisa Medicamentos and Envixia Pharmaceuticals. Further, Anvisa suspended Covaxin trials the same day.

On July 24, Brazil officially cancelled Bharat Biotech’s EUA request. The National Health Surveillance Agency of Brazil stated that it decided to close the process that dealt with the temporary authorization of emergency use of the Covaxin. Two days later, Anvisa cancelled the phase 3 clinical trials of Covaxin on the request of Precisa – one of the intermediaries. Anvisa, in its website, said that the collegiate board unanimously decided to provisionally suspend the exceptional and temporary authorization for import and distribution of Covaxin.

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first published:July 29, 2021, 20:09 IST