RIO DE JANEIRO, BRAZIL – On Monday, the agency voted on the import, distribution and administration of the Russian immunizer following a request by 10 states.
In an extraordinary meeting of the Brazilian Health Regulatory Agency’s (ANVISA) board of directors on Monday, April 26th, the agency denied the exceptional and temporary import of the Russian Sputnik V vaccine.
The exceptional and temporary import authorization was requested by the states of Bahia, Acre, Rio Grande do Norte, Maranhão, Mato Grosso, Piauí, Ceará, Sergipe, Pernambuco and Rondônia. This release would allows the immunizers to be bought, distributed, and administered to the population.
According to Law 14.124, in this modality, the applicant that failed to send a technical report of the vaccine’s evaluation for the emergency use request will have the process analyzed by ANVISA in up to 30 days. In the case of Sputnik V, the agency lodged a request for an extension with the Supreme Court, which was rejected by justice Ricardo Lewandowski.
“It is a quicker and speedier process, where ANVISA is limited to assessing, from a technical report issued by an international agency, whether or not safety and efficacy aspects were observed,” explains director Alex Machado, rapporteur of the process.
Source: Metropoles
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