Hyderabad: After Bharat Biotech stopped the MoU with Brazilian partner Precisa Medicamentos on Friday, Brazilian Health Regulator Anvisa (Agencia Nacional de VigiLancia Sanitaria) said it had suspended the clinical trial Covaxin in Brazil.
Precisa has submitted a request for a random phase-3 study, Double-Blind and Covaxin controlled placebo in Brazil to Anvisa.
“Coordination of clinical research determines Friday the caution suspension of Covaxin clinical studies in Brazil,” said Anvisa notices on the website.
“The suspension was carried out as a result of a statement from Indian company Bharat Biotech Limited International, sent to Anvisa on Friday (7/23).
In that statement, Bharat told that the company’s needs Comercializacao de Medicamentos LTDA was no longer authorized to represent Bharat in Brazil, What in Anvisa’s assessment makes it impossible to carry out research.
Bharat is a covaxin vaccine manufacturer, “Anvisa said.
“Letters that communicate the cautious suspension sent to the Instituto Albert Einstein and Sponsor of Research, the company needs Comercialização de Medicamentos Ltd.
The application of vaccines in Brazilian volunteers does not occur,” said Brazilian Health Regulator.
The Phase-3 study, which was approved by Anvisa in mid-May this year, had to be done at 4,500 volunteers aged 18 years and over in Sao Paulo, Rio de Janeiro, Bahia and Mato Grosso.
Late on Friday night, Bharat Biotech announced a direct termination of his agreement with Precisa Medicamentos and Envixia Pharmaceuticals LLC, pulling a plug of a $ 324 million deal for a supply of 20 million covaxin doses to Brazil.
However, Hyderabad-based vaccine makers said they would continue to work with Anvisa to complete the regulatory approval process for Covaxin.
The Covaxin agreement was under the scanner and was suspended by Brazil after alleged irregularities arose against the Brazilian government Jair Bolsonaro.
While ending the deal, Bharat Biotech said in a statement: “We have recently been told that certain letters, which are intended to be implemented by company executives, are being circulated online.
We want to firmly state that these documents have not been issued by the company or executive and therefore loud deny the same thing.
“” The company also emphasizes that all its actions, including global transactions, are carried out in accordance with local law and that the company employs and follows the highest ethical, integrity, and compliance standards every time, ” said Bharat Biotech.