Brazil scraps Covaxin’s emergency use application after Bharat Biotech terminates pact with partners

PTI Hyderabad | Updated on July 27, 2021

Move follows suspension of planned clinical trials of the Covid-19 vaccine in Brazil

After suspending the proposed clinical trials of Bharat Bioetch’s Covid-19 vaccine Covaxin, Brazil has now scrapped the company’s Emergency Use Authorisation request for the jab.

The Brazilian health regulator’s decision comes after the vaccine maker informed the South American country about the termination of its pact with its partners in that country.

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According to a statement issued by the National Health Surveillance Agency of Brazil, Anvisa, its Collegiate Board, on Saturday unanimously decided “to close the process that dealt with the temporary authorisation of emergency use, on an experimental basis, of the Covaxin vaccine”.

Earlier Anvisa had suspended the clinical studies of Biotech’s Covaxin in Brazil following the termination of the company’s agreement with its partners there.

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“The decision was taken after Anvisa was informed by the Indian company Bharat Biotech International Limited that the company Necessidade no longer has authorisation to represent Bharat Biotech, manufacturer of the Covaxin vaccine, in Brazil,” Anvisa said.

Anvisa’s decision refers to the request for emergency use of Covaxin that had been filed by the Brazilian company Necessidade with Anvisa.

Bharat Biotech on July 23 said it had terminated its MoU with Precisa Medicamentos and Envixia Pharmaceuticals LLC for Covaxin for the Brazilian market.

The termination of the MoU came after the deal with the Brazilian Government for the supply of 20 million doses of Covaxin landed in controversy and attracted investigation by authorities in that country.

Following the graft allegations and subsequent inquiry by the authorities, the Brazilian government had earlier suspended Covaxin’s order temporarily.

Bharat Biotech will continue to work diligently with Anvisa, to complete the regulatory approval process for Covaxin, Bharat Biotech had said while announcing the termination of its pact with its Brazilian partners.

Published on July 27, 2021

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