Vaccines Approved Abroad May Be Endorsed for Emergency Use in Brazil

RIO DE JANEIRO, BRAZIL – Governors who met with Minister of Health Eduardo Pazuello on Tuesday, December 8th, stated that vaccines approved by international regulatory agencies may be cleared for emergency use in Brazil. In such cases, the National Health Regulatory Agency (ANVISA) will have 72 hours to assess the immunizer before clearing it.

“What he [Pazuello] made clear to us is that measures are being taken and all vaccines certified by international agencies will be assessed within 72 hours by ANVISA, as required by law, and will be implemented for emergency use. Not in the policy extended to all, but for those at greater risk,” explained the governor of Goiás, Ronaldo Caiado.

Emergency use will be restricted to people in risk groups, with priority to healthcare professionals, according to the governors. “Priority would be given mainly to the healthcare sector, which is in the frontline, assisting patients in ICUs, outpatient clinics and wards. From there, there would be a register by age, comorbidities and then public security”, said Caiado.

Under the legislative regulations, if ANVISA does not bar a vaccine in 72 hours, it will be deemed cleared for use. In case the agency fails to issue its opinion, its approval will be “tacit”, according to the governor of Goiás. “Should it fail to issue an opinion, it will be authorized,” said Caiado. Pfizer’s vaccine, for instance, which should announce its registration by the United States food and drug agency, may be released by ANVISA for emergency use thereafter.

These guidelines are restricted to emergency use only. The deadline for the immunization plan of the entire population is different. ANVISA will have 60 days to authorize the use of vaccines. “The deadline for what is directly submitted to ANVISA is 60 days, as stated by the Minister. This is a fact and we have told him that we are in an exceptional moment and we therefore need an exceptional response,” said the governor of Pará, Helder Barbalho.

“We are governed by a federal statute in force and, given the pandemic, it is required that whatever is approved by four international agencies should be used on domestic territory, with the registration of ANVISA,” said Barbalho. This is provided in Law No. 13,979, passed in February 2020, which establishes measures to fight the novel coronavirus pandemic.

The authorities may grant “exceptional and temporary authorization for the import and distribution of any materials, drugs, equipment and supplies in the health area subject to health monitoring without ANVISA registration which are considered essential to assist in fighting the coronavirus pandemic,” reads the statute.

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According to Barbalho, Pazuello guaranteed that all vaccines will be distributed proportionally to states and municipalities, with no distinction. “We point out that the leadership of the Ministry of Health is crucial, that it is not possible to differentiate between states. The Ministry must effectively exercise its leadership in this process, to ensure an immunization plan equally to all Brazilians, to all units of the federation,” he said.

The governors stated that Pazuello said that he would submit the federal logistics plan for vaccine distribution on Wednesday, December 9th. “The Minister should publicly issue an official statement to advise society regarding this schedule, to reassure all Brazilians that no state will be left unsupported and without coverage,” he said.