Brazil suspends phase-3 trials of Covaxin | Hyderabad News | Sidnaz Blog

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HYDERABAD: After Bharat Biotech terminated its MoU with Brazilian partner Precisa Medicamentos on Friday, Brazil’s health regulator Anvisa (Agencia Nacional de Vigilancia Sanitaria) said it has suspended Covaxin’s clinical trials in Brazil. Precisa had submitted a request for randomised, double-blind and placebo-controlled phase-3 study of Covaxin in Brazil to Anvisa.
“The Coordination of Clinical Research determined this Friday the precautionary suspension of clinical studies of Covaxin in Brazil,” said a notice by Anvisa on website.
“The suspension was carried out as a result of a statement from the Indian company Bharat Biotech Limited International, sent to Anvisa on Friday (23/7). In the statement, Bharat informs that the company Necessidade Comercializacao de Medicamentos Ltda is no longer authorized to represent Bharat in Brazil, which in Anvisa’s assessment makes it impossible to carry out the study. Bharat is the manufacturer of the Covaxin vaccine,” Anvisa said.
“The letters communicating the precautionary suspension were sent to Instituto Albert Einstein and the sponsor of the study, the company Necessidade Comercialização de Medicamentos Ltda. The application of the vaccine in Brazilian volunteers did not happen,” the Brazilian health regulator said.
The Phase-3 study, which was approved by Anvisa in mid-May this year, was to be carried out on 4,500 volunteers aged 18 years and above at Sao Paulo, Rio de Janeiro, Bahia and Mato Grosso.
Late on Friday evening, Bharat Biotech announced the immediate termination of its deal with Precisa Medicamentos and Envixia Pharmaceuticals LLC, pulling the plug on the $324 million deal for supply of 20 million doses of Covaxin to Brazil.
However, the Hyderabad-based vaccine maker said it would continue to work with Anvisa to complete the regulatory approval process for Covaxin.
The Covaxin deal had come under the scanner and was suspended by Brazil after allegations of irregularities surfaced against Brazilian President Jair Bolsonaro’s government.
While terminating the deal, Bharat Biotech said in a statement: “We have very recently been informed that certain letters, purported to have been executed by executives of the company, are being circulated online. We would like to emphatically state that these documents have not been issued by the company or its executives and therefore vehemently deny the same.”
“The company also stresses that all its actions, including its global dealings, are done in accordance with local laws and that the company employs and follows the highest standards of ethics, integrity and compliance at all times,” Bharat Biotech had said.

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