Anvisa approves temporary authorization for emergency use of vaccines against Covid-19

SÃO PAULO – A Anvisa (National Health Surveillance Agency) decided on Thursday (10) to approve a proposal that will give temporary authorization for emergency use, on an experimental basis, for the Covid-19 vaccines.

According to Alessandra Bastos, Anvisa director and rapporteur for the proposal, the agency does not yet have regulations on the emergency use of drugs and vaccines in the event of a public health emergency.

“Knowing that there is an urgent and unmet need related to Covid-19, there is the reason for an emergency use authorization as a mechanism that can facilitate the availability and use of vaccines,” said Alessandra at the XI Extraordinary Meeting of the Collegiate Board. Anvisa.

The approval of the director’s proposal, while there is still no regulation, was confirmed by Antônio Barra Torres, general manager of Anvisa, after the vote of the other members of the Board.

By the new procedure, the companies that today produce the different immunizers against the new coronavirus (see below) you can request a concession in this regard. If authorized, vaccines may come into use, including public vaccination programs, pending the final registration process.

Anvisa states that it has not yet received any request for temporary authorization for emergency use. “So far, there is nothing new in the document protocol requesting emergency use or vaccine registration. We will only be able to approve the processes if the companies present the requests in the ordinary channels of the requests for analysis ”, said Alessandra.

Vaccines against Covid-19

The Minister of Health, Eduardo Pazuello, said on Wednesday (9) that the vaccination against Covid-19 in Brazil can begin in December or early next year, between January and February.

Deliveries scheduled for early 2021 include 15 million doses of the vaccine developed by the pharmaceutical company AstraZeneca and the University of Oxford. The agreement with the Ministry of Health implies the purchase of 100 million doses in total.

Also in deliveries for early 2021, the Ministry of Health mentions 500,000 initial doses of the vaccine produced by the pharmaceutical company Pfizer and by the German laboratory BioNTech. The Pfizer / BioNTech vaccine had its emergency use approved on Thursday (10) by the FDA, the US drug regulatory agency.

These two vaccines are the Federal Government’s biggest bets. At the state level, the São Paulo State Government bets on CoronaVac, a vaccine produced by the Butantan Institute in partnership with the Chinese pharmaceutical company Sinovac. 46 million doses should be available by January 2021, according to the Government of São Paulo.

See a summary of the various immunizers tested and produced to combat Covid-19, as well as their relationship with Brazil:

More information at a time.

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