What went wrong with Bharat Biotech’s Covaxin agreement with Brazil?

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Bharat Biotech’s Covaxin deal with Brazil got mired in allegations of irregularities, partnership problems, etc.

What went wrong with Bharat Biotech's Covaxin agreement with Brazil?
What went wrong with Bharat Biotech’s Covaxin agreement with Brazil?

Hyderabad-based Bharat Biotech canceled its agreement with two firms to supply Covaxin on Friday after the Brazilian government canceled the deal over graft allegations. Brazil suspended the clinical studies the Indian vaccine maker was about to conduct there on Saturday. After the Brazilian government suspended its deal with Bharat Biotech to procure 20 million doses of Covaxin, all of this happened in a chain reaction.

A look at why the Covaxin deal in Brazil failed for Bharat Biotech’s.

Bharat Biotech entered into an agreement with Precisa Medicamentos and Envixia Pharmaceuticals LL.C. in November 2020. As a partner, Bharat Biotech provides assistance, guidance, and support with regulatory submissions, licensing, distribution, insurance, and conducting phase III clinical trials.

The clinical trial has to be suspended naturally since Precisa has represented Bharat Biotech in Brazil so far and will not do so in the future.

An allegation of graft or a partnership dispute?

Bolsonaro’s government faced allegations of corruption in its agreement with Bharat Biotech, which remains under investigation. Brazilian whistleblowers said there was pressure from higher authorities regarding the Bharat Biotech deal. Furthermore, it was alleged that Pfizer gave vaccines to Brazil at a cheaper price. As a result, the deal was canceled and the Brazilian government said that there was no corruption since Bharat Biotech was not paid. Neither the Brazilian government nor Bharat Biotech has authorized the company to receive any advance payments.

As Bharat Biotech has now distanced itself from these two firms, it has also made some allegations without specifically targeting anyone firm. There have been reports online that letters purportedly signed by company executives are circulating. The company and its executives have not issued these documents and therefore vehemently deny them,” Bharat Biotech said in a statement on Friday.

What is the status of Covaxin in Brazil?

Bharat Biotech’s Covaxin was said to have received approval from Brazil’s health regulator Anvisa on June 4, when the deal was announced. In the end, it was clarified that on June 4 Anvisa authorized the ministry of health to import Covaxin vaccine under controlled conditions for distribution and use.

Bharat Biotech said it will work diligently with Anvisa to complete the regulatory approval process now that the deal has been canceled.

“The company is working on two processes for regularizing Covaxin in Brazil – an application for emergency use and a protocol for conducting clinical research there. As a result of the communication from Bharat Biotech, Anvisa will reevaluate the processes underway at the agency and take the necessary measures,” Brazil’s health regulator said, according to news agency PTI.

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