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Brazil suspends Bharat Biotech's Covaxin clinical trials

Our Bureau Hyderabad | Updated on July 24, 2021

File photo   -  The Hindu

There was a controversy related to the deal with Brazil’s government for supply of 20 million doses of the vaccine

Brazilian health regulator Anvisa has suspended the clinical trials of Bharat Biotech's Covid-19 vaccine, Covaxin, terming it a precautionary measure after the latter terminating its Memorandum of Understanding (MoU) with its Brazilian partners Precisa Medicamentos and Envixia Pharmaceuticals LLC.

Announcing its decision late on Friday evening, Anviasa has said that the application of the vaccine in Brazilian volunteers did not happen.

The regulator said it took the decision after receiving an intimation from the Indian company it no longer authorised Necessidade to represent it in Brazil. This, in Anvisa's assessment, makes it impossible to carry out the study".

"The letters communicating the precautionary suspension were sent to Instituto Albert Einstein and the sponsor of the study Necessidade Commercializacao de Medicamerntos Ltda," Anvisa said in its statement.

Announcing the termination of its memorandum of understanding on Friday, Bharat Biotech said it would continue to work diligently with Anvisa to complete the regulatory approval process for Covaxin.

The two sides signed the memorandum of uderstanding in November 2020 to introduce Covaxin to Brazil. As per the agreement, Precisa Medicamentos was Bharat Biotech's partner in Brazil for assistance, regulatory submissions, licensure, and conduct of phase-III clinical trials.

However, in the wake of allegations of irregularities in the deal for the supply of 20 million doses of the vaccine, the Government of Brazil suspended the contract pending investigation.

Published on July 24, 2021

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