Anvisa management waives the registration and emergency authorization for the Covax Facility vaccines | Vaccine



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The National Health Surveillance Agency (Anvisa) decided on Tuesday (9) that vaccines purchased by the Ministry of Health through the Covax Facility are exempt from the registration requirement and temporary authorization for emergency use.

The Covax Facility is a coalition of more than 150 countries created to drive the development and distribution of Covid-19 vaccines. The initiative is led by the World Health Organization (WHO).

Brazil should receive 10.6 million doses of Covax vaccines in the first half. The country’s agreement with the WHO to receive a total of 42 million doses will cost R $ 2.5 billion.

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Deadlock on new orders

The decision of the Anvisa collegiate council resolves a possible impasse: Anvisa had stated that even the Oxford vaccine, already approved for emergency use in the country, would need a new registration application depending on the place of production and the form of presentation of the doses Covax will send you.

The emergency registry already granted analyzed Oxford vaccines produced and completed by the Serum laboratory in India. If there was a change of supplier, another order of use would be needed. With Anvisa’s most recent decision, a new order will no longer be necessary for the Oxford vaccine or another vaccine to be shipped by the alliance in the future.

Covax plans to deliver 1.8 billion doses of vaccines to the 92 poorest countries in 2021
Covax plans to deliver 1.8 billion doses of vaccines to the 92 poorest countries in 2021

1 minute Covax plans to deliver 1.8 billion doses of vaccines to the 92 poorest countries in 2021

Covax plans to deliver 1.8 billion doses of vaccines to the 92 poorest countries in 2021

Brazil is not on that list, which has most of the countries in Africa and Asia. The vaccine consortium led by the World Health Organization foresees shipping to the richest countries only in the second half.

Expected doses for Brazil and the world

In October, the executive secretary of the Ministry of Health, Elcio Franco, reported that Brazil’s contribution to the global alliance provided, in return, the receipt of 42 million doses of vaccines.

This total would be enough to cover 10% of the Brazilian population, which is equivalent to approximately 21 million people (considering the need for a double dose).

The Covax alliance will provide at least 2 billion doses of vaccines by the end of 2021 and 92 poor countries are expected to have access to 1.3 billion doses in the first half. Brazil participates in the alliance, but is not on the list of the poorest countries.

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