Hyderabad: After closing an emergency use business (EUA) and the clinical test request for phase-3 for Bharat Biotech’s Covaxin, Brazilian Health Regulator Anvisa (Agencia Nacional de Vigilancia Sanitaria) has now decided to suspend the extraordinary authorization of 4 million doses of Covid vaccine-19 India.
“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, 2021, Bharat Biotech had told Anvisa that Precisa Medicamentos was no longer authorized to represent him in Brazil.
According to Anvisa, Director of Alex Machado Campos, Rapporeur on this issue, “assumed that the loss of the company’s legitimacy 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 is no covaxin dose imported by Brazil so far, Anvisa said the extraordinary imports authorization needed compliance with the obligations and conditions stipulated in the provisions of the Reporting Voting for the purposes of distribution and the use of controlled vaccines in controlled conditions.
Extraordinary and temporary imports from Covaxin for distribution and use in controlled conditions have been authorized on June 4, 2021, at the 9th extraordinary meeting of the Board of Collegiate Anvisa.
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.
Brazil has suspended the Covaxin agreement at the end of June after alleged irregularities against the government of President Jair Bolsonaro leading to allegations that at $ 15 doses of covaxin are valued higher than other Pfizer’s choice such as the Pfizer vaccine.