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Brazil shelves import authorisation of Covaxin days after scrapping EUA request

Brazil shelves import authorisation of Covaxin days after scrapping EUA request

According to a statement issued by Brazil's National Health Surveillance Agency, Anvisa, its Collegiate Board on Tuesday decided to suspend the authorisation for import and distribution of Covaxin in the country after Bharat Biotech informed the South American government about the termination of its pact with its Brazilian partners

Earlier on Friday, Bharat Biotech said it had terminated the MoU to sell Covaxin to Brazil's Precisa Medicamentos and Envixia Pharmaceuticals LLC Earlier on Friday, Bharat Biotech said it had terminated the MoU to sell Covaxin to Brazil's Precisa Medicamentos and Envixia Pharmaceuticals LLC

Brazil has now suspended its decision to import 4 million doses of Bharat Biotech's Covid-19 vaccine Covaxin into their nation. This comes shortly after the country suspended the proposed clinical trials of Covaxin as well as a request for Emergency Use Authorisation.

According to a statement issued by Brazil's National Health Surveillance Agency, Anvisa, its Collegiate Board on Tuesday decided to suspend the authorisation for import and distribution of Covaxin in the country after Bharat Biotech informed the South American government about the termination of its pact with its Brazilian partners.

"The Collegiate Board of Anvisa unanimously decided on Tuesday to provisionally suspend the exceptional and temporary authorisation for import and distribution of the vaccine against Covid-19-Covaxin, requested by the Ministry of Health," Anvisa said in a statement posted on its website.

Earlier on Friday, Bharat Biotech said it had terminated the Memorandum of Understanding (MoU) to sell its Covid-19 vaccine Covaxin to Brazil's Precisa Medicamentos and Envixia Pharmaceuticals LLC.

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

"The measure prevails until there is new information that allows us to conclude that the legal and technical security of maintaining the decision that authorised the importation is maintained," Anvisa further said in a roughly translated version of Portuguese of the statement.

Although the exceptional and temporary importation of Covaxin had been authorised on June 4 at the ninth Extraordinary Meeting of the Collegiate Board of Anvisa, Brazil did not import the jab.

Bharat Biotech said, while announcing the termination of its pact with its Brazilian partners, that it will continue to work diligently with Anvisa to obtain all required approvals for the use of Covaxin in the country.

Edited by Rupashree Ravi

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