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Montevideo, September 16th 2021 - 12:00 UTC

 

 

Brazil dispute with Pfizer vaccine; pledges emergency use for AstraZeneca's shots probably by mid January

Thursday, December 31st 2020 - 08:35 UTC
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In theory, Brazil's emergency use authorization allows for fast-track usage of a COVID-19 vaccine among certain high-risk patients In theory, Brazil's emergency use authorization allows for fast-track usage of a COVID-19 vaccine among certain high-risk patients

Brazil will soon weigh emergency-use approval for AstraZeneca's COVID-19 vaccine after Britain gave the green light on Wednesday, as Latin America's largest country rushes to catch up with immunization programs under way around the hard-hit region.

Brazil's health regulator Anvisa met with AstraZeneca Plc representatives said the company's local partners, federally-funded biomedical institute Fiocruz, will file for emergency use authorization, without saying when.

Britain became the first country in the world to give full regulatory approval to the coronavirus vaccine developed by Oxford University and AstraZeneca. The U.K. approval offers hope to Brazil, which has made the cheap and sturdy British vaccine a cornerstone of its widely criticized vaccine plan.

President Jair Bolsonaro, a prominent coronavirus skeptic who has said he will not take any COVID-19 vaccine, is under pressure to speed up Brazil's rollout, as regional peers Mexico, Chile and Argentina have already begun immunizations. Brazil's government has given a best-case-scenario date of Jan. 20 for AstraZeneca vaccinations to begin.

In theory, Brazil's emergency use authorization allows for fast-track usage of a COVID-19 vaccine among certain high-risk patients. It is a slimmed down version of a full regulatory approval for nationwide rollout.

However, Pfizer Inc has complained that Brazil's emergency use application is especially onerous, souring relations with the federal government and leading critics to decry bureaucratic hurdles just as the virus roars back to life. Brazil recorded 1,194 deaths on Wednesday, the worst daily death toll reported by the Health Ministry since September.

The government defended itself against criticism of its vaccine plan on Tuesday, saying it was hamstrung by local laws that only allow it to sign purchase agreements once producers have emergency use authorizations or full authorizations.

Nonetheless, it also pledged to improve dialogue with Pfizer, whose vaccine is already being used in Britain and the United States.

Its new stance appears to be bearing fruit. On Wednesday, Pfizer said that health regulator Anvisa had suggested to the company in a meeting that it could tweak certain requirements to help expedite emergency use approval. Anvisa, in a statement, confirmed its willingness to modify certain requirements.

Pfizer said it would consider whether to apply for emergency use, adding that it continues to regularly submit trial data to Anvisa as part of the full authorization process.

Rio de Janeiro-based Fiocruz, which has agreed to import and bottle some 100 million doses of the AstraZeneca vaccine by June and eventually produce the vaccine locally, had previously said it would seek full regulatory approval for the shot on Jan. 15.

On that basis, officials have said nationwide vaccinations could, at the earliest, begin on Jan. 20.

Once submitted, Anvisa said it will take up to 10 days to review the application, adding that the ongoing submission of late-stage trial results would help to accelerate the process.

Earlier in the day, AstraZeneca said it was working to offer its COVID-19 vaccine to Brazilians as soon as possible, but made no mention of seeking emergency use approval.

While some vaccines, such as Pfizer's COVID-19 shot, must be super cooled to -70 degrees Celsius (-94 Fahrenheit), the AstraZeneca vaccine only needs normal refrigeration, making it a more robust candidate for developing countries such as Brazil.

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