Brazil cancels Covaxin's emergency use application
Image from Bharat Biotech's website

Asian Tech Press -- Brazil has decided to cancel the application for an emergency use authorization for India's Covaxin COVID-19 vaccine, India's largest news agency Press Trust of India (PTI) reported on Tuesday.

Just a month ago, Brazil's health department called off the procurement of 20 million doses of Covaxin vaccine.

According to a statement released by the Brazilian Health Regulatory Agency (Anvisa), members of the commission decided unanimously on Saturday to "cancel the process of authorizing the emergency use of the Covaxin vaccine.

The decision comes after the Brazilian government signed a contract with India's Bharat Biotech for the purchase of 20 million doses of the Covaxin vaccine, worth more than $300 million.

On June 4 of this year, Brazilian media claimed that Anvisa approved the emergency use authorization (EUA) for the Indian Covaxin COVID-19 vaccine in Brazil, but Anvisa denied this shortly after.

At that time, the Covaxin vaccine had not yet published the test report of the phase III clinical trial, and some media predicted that Brazil could call off the import and use of the vaccine at any time.

Subsequently, a corruption-related case against Brazilian President Jair Bolsonaro disrupted Covaxin's procurement process. Brazilian media broke the news that cables from the Brazilian Embassy in India showed that the price of Covaxin vaccine in India was $1.34 per dose, but the Brazilian government was purchasing it for as much as $15 each.

Three Brazilian senators formally reported to Brazil's Supreme Court on June 28, accusing Bolsonaro of malfeasance, and Brazil's Health Ministry suspended the Covaxin procurement contract late last month.

Late last Friday, India's Bharat Biotech terminated a memorandum of understanding (MoU) with two Brazilian drug companies, Precisa Medicamentos and Envixia Pharmaceuticals LLC, after the vaccine deal was disrupted by the corruption-related case.

Under the previous agreement, the two Brazilian pharmaceutical companies would have been responsible for the application licensing and distribution of Bharat's Covaxin COVID-19 vaccine in Brazil, as well as providing assistance and support for the phase III clinical trials of the vaccine in Brazil.

In a statement the same day, Bharat said the company would continue to work with Anvisa to complete the process of regulatory approval for the Covaxin vaccine, despite the termination of the collaboration with the two Brazilian firms.

But against all expectations, Anvisa also suspended phase III clinical trials for the Covaxin vaccine in the country after Bharat halted its partnership with them.

According to the latest data from Brazil's health department on July 26, the cumulative number of confirmed cases in Brazil has surpassed 19.7 million and causally died in more than 550,000 cases.

Up to now, Brazil ranks third in the world after the United States and India in terms of the number of confirmed cases and second in the world after the United States in terms of the cumulative number of deaths.

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