Wednesday, April 14, 2021

Lewandowski releases municipalities and states to import vaccines if Anvisa fails to meet deadline – Prime Time Zone

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Brazilian health agency has 72 hours after request to allow use of immunizer registered with regulatory bodies in other countries

Wallace Martins / Estadão Content – 4/13/2020According to Ricardo Lewandowski, states and municipalities can import immunizers if the federal government’s vaccination plan is not fulfilled

The Minister of the Supreme Federal Court (STF) Ricardo Lewandowski authorized states, municipalities and the Federal District to import any vaccine registered with health agencies in other countries if the National Health Surveillance Agency (Anvisa) it takes more than 72 hours after the request arrives to authorize the use of the foreign immunizer in national territory. Anvisa claims that the law provides for a 72-hour period to approve or not the use of vaccines for Covid-19 registered by the health authorities of the United States, Europe, China or Japan. The automatic guarantee will only be granted if the agency does not manifest itself within this period.

The immunizer of Pfizer, for example, obtained only this emergency endorsement in the USA and the United Kingdom, where it has already started to be used. Anvisa’s request to import and distribute a vaccine already registered in another country can only be made by manufacturers. In other words, a governor cannot take this initiative. Anvisa’s normal deadline for analyzing vaccine records against Covid-19 is up to 60 days. Time may drop if the manufacturer has adopted “continuous submission” of documents and has already delivered part of its studies. Also if registered with the health authorities mentioned in the law. Registered, the vaccine can be distributed en masse (even to the private network). In the case of emergency use, the agency estimates that it will take up to ten days in the analysis. This type of emergency application can only be done in the Single Health System (SUS), in restricted groups, such as the elderly and health professionals. There are still no requests for registration of vaccines or emergency use to Anvisa.

Lewandowski made the same decision in two different cases: one from the government of Maranhão and another from the Federal Council of the Brazilian Bar Association (OAB), which made the request for all Brazilian states and municipalities. On the 9th, the Federal Council of the OAB filed a lawsuit in the Supreme Court pointing out the government’s omission Jair Bolsonaro due to the delay in providing a definitive national immunization plan and guaranteeing the effective access of the population to the vaccine against Covid-19. “The immeasurable severity of the emergency situation caused by the coronavirus pandemic demands from all Brazilian authorities, at their different levels of government, the concrete realization of the protection of public health and guarantee of life and human dignity”, claimed the OAB.

* With information from Estadão Content

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