Hyderabad: After suspending clinical trials of Covaxin following the termination of Bharat Biotech’s Memorandum of Understanding with its Brazilian partner Precisa Medicamentos, Brazil’s health regulator Anvisa (Agencia Nacional de Vigilancia Sanitaria) has now closed its Emergency Use Authorization (EUA) application for the Indian vaccine as we will.
Anvisa said it decided to close the operation that handled the temporary emergency use authorization of Covaxin without evaluating its merits following Bharat Biotech informed it that Precisa was no longer authorized to represent the company in Brazil.
“The Collective Board of the National Health Surveillance Agency decided unanimously … to close the operation that dealt with the temporary authorization of the emergency use of the Covaxin vaccine, on a trial basis. The operation will be closed without evaluating the merits of the application for a provisional authorization for emergency use, on a trial basis, submitted by Necessidade Comercialização de Medicamentos Ltda on June 29 this year,” read a loosely translated version of the notice posted on the Anvisa website.
According to Anvisa, Director Meiruze Freitas, process rapporteur, highlighted in the vote that “disruption of the business relationship between companies, as well as the erosion of one of the basic requirements of an emergency use authorization, implies impeding the maintenance and continuation of the evaluation of the application. Since it is based on the principle of efficiency, proceeding with the technical evaluation of an already administratively damaged petition would unkind a significant waste of management efforts and resources.”
The latest development came following Anvisa suspended proposed Phase 3 clinical trials of Covaxin, which were to be performed on about 4,500 volunteers over the age of 18 in Brazil, over the weekend.
Late Friday evening, Bharat Biotech announced the immediate termination of its deal with Precisa Medicamentos and Envixia Pharmaceuticals LLC, pulling a $324 million deal to supply Brazil with 20 million doses of Covaxin.
However, Bharat Biotech said it will persevere to work with Anvisa to conclude the regulatory approval process for Covaxin. With Anvisa canceling clinical trials and requesting an EUA, Bharat Biotech will now have to start the process over.
Brazil suspended the Kovaccin deal at the end of June amid allegations of wrongdoing against the government of Brazilian President Jair Bolsonaro. The Covaxin deal also came under scrutiny following allegations emerged that the deal was inflated and closed in haste despite cheaper vaccine options.
In its statement announcing the termination of the deal with Precisa, Bharat Biotech referred to some messages, written in Portuguese and allegedly executed by its executives, circulating online and emphatically asserted that these documents were not issued by the company or its executives.
Bharat Biotech also emphasized that all of its business, including its global dealings, was conducted in accordance with local laws and that “the company employs and pursues the highest standards of ethics, integrity and compliance at all times.”