Hyderabad: After closing the emergency use permit (EUA) and clinical requests for phase-3 requests for Bharat Biotech Covaxin, Brazilian Health Regulator Anvisa (Agencia Nacional de Vigilancient Sanitaria) has now decided to temporarily suspend authorization for the extraordinary import of 4 million doses of Indian vaccine Covid-19.
“The Board of Collegiate Anvisa unanimously decided, on Tuesday (27/7), temporarily suspended the authorization of extraordinary and temporary for the imports and distribution of vaccines against Covid-19, Covaxin, which was requested by the Ministry of Health,” said a translation.
The notification version appears on the Anvisa website.
“The size is valid until there is new information that allows us to conclude that legal and technical security maintains decisions that ratify imports are maintained,” Anvisa said.
The decision followed the termination of Bharat Biotech from his partnership with Brazilian partner Precisa Medicamentos.
On July 23, Bharat Biotech had told Anvisa that Precisa Medicamentos was no longer authorized to represent her in Brazil.
According to Anvisa, Director of Alex Machado Campos, the reporting on this issue, “assumed that the loss of the legitimacy of the Precisa company to act before Anvisa could affect the fulfillment of import requirements and conditions.” “The decision also takes into account the news that illegal documents may have been added to the import process, which can have an impact on the conclusion of the aspects of the quality, safety and efficacy of vaccines to be used by the national population,” Anvisa said.
Indicates that there are no covaxin doses imported by Brazil so far, Anvisa says outstanding import authorization requires compliance with the obligations and conditions stipulated in the provisions of RAPPORUR vote for the purposes of distribution and use of controlled vaccines.
Extraordinary and temporary imports of Covaxin for distribution and use in controlled conditions have been authorized on June 4, at the 9th extraordinary meeting of the Board of Collegiate Anvisa.
In voting, the reporter told him that he called legal lawyers agency and promoted actions with the developer of Bharat Biotech vaccine and the Ministry of Health.
Bharat Biotech also, after ending the agreement with Precisa, it has said that he will continue to work with Anvisa to complete the regulatory approval process for Covaxin.
After the termination of Hyderabad-based vaccine makers with the Precisa ended the $ 324 million deal for the supply of 20 million doses of Covaxin to Brazil, Anvisa first suspended the phase-3 clinical trial which was proposed from the Covaxin which would be carried out at 4,500 Brazil and then closed the request of EUA.
After the termination of Bharat Biotech from the agreement with the Precisa ended the agreement of $ 324 million for the supply of 20 million covaxin doses to Brazil, Anvisa first suspended phase-3 clinical trials proposed from Covaxin and then closed the request of EUA.