Hyderabad: After suspending the covaxin clinical test after the termination of Bharat Biotech’s Mou with Brazilian Partners Precisa Medicamentos, Brazilian Health Regulator Anvisa (Agencia Nacional de Vigilancia Sanitaria) has now closed the request of Emergency Use Authorization (EUA) for Indian vaccines as well.
Anvisa said it decided to close the process that was dealing with the temporary authorization of the Emergency use of Covaxin without evaluating its benefits after Bharat Biotech told him that Precisa was no longer authorized to represent the company in Brazil.
“The Universities Board of the National Health Supervisory Agency decided …
to close the process of dealing with the temporary authorization of emergency use, based on experiments, from the Covaxin vaccine.
The process will be closed without evaluating the benefits of temporary authorization requests for emergency use, based on experimental, based on experimental By the company’s comercialização de Medicamentos Ltda on June 29 this year, “Read the notification version translated loosely.
on the Anvisa website.
According to Anvisa, Director of Meiruze Freitas, reporting process, highlighted in voting that “commercial relationship disorders between the company, and decay of fundamental requirements for authorization of emergency use, implying barriers to the maintenance and continuity of demand evaluation.
Because of anchoring in the principle of efficiency, in the future with evaluation The technical technical petition that has administratively imply significant waste from administrative efforts and resources.
“The latest developments came after Anvisa suspended phase-3 clinical trials proposed from Covaxin, which will be carried out at around 4,500 volunteers over 18 years in Brazil, during weekend.
Bharat Biotech has been, at the end of Friday night, 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, Bharat Biotech said that it would continue to work with Anvisa to complete the regulatory approval process for Covaxin.
With Anvisa canceling the clinical trial and EUA request, Bharat Biotech must now start the process again.
The Covaxin agreement was suspended by Brazil at the end of June amid allegations of irregularities against the government of Brazilian President Jair Bolsonaro.
The Covaxin deal was also under the scanner after the allegations appeared that the deal was too expensive and hastily hit even though there was a cheaper vaccine option available.
In a statement announced the termination of the agreement with Precisa, Bharat Biotech had offended several letters, written in Portuguese and said that the executives were executed, circulated online and firmly stated that these documents were not issued by the company or said.
executives.
Bharat Biotech also emphasizes that all his 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 at any time”.
Covid-19: After suspending the covaxin clinical trial, Brazil closed the request of EUA
