Brazil seeks AstraZeneca vaccine's regulatory approval

Brazil to seek regulatory approval for AstraZeneca Covid-19 vaccine on January 15

Credit: Reuters photo.

Brazil's Fiocruz biomedical institute will seek approval for the Oxford University/AstraZeneca vaccine against COVID-19 with federal health regulator Anvisa on Jan. 15, one of the center's senior officials said on Monday.

The Jan. 15 date brings a measure of clarity to Brazil's vaccine rollout, which critics have blasted for falling behind smaller and poorer peers in Latin America. The AstraZeneca vaccine represents the Brazilian government's main bet to help end the world's second-most deadly coronavirus outbreak, after the United States.

"The final submission of this process, this last milestone, will be on Jan. 15," Marco Krieger, vice president of health production and innovation at the Rio de Janeiro-based Fiocruz institute, told Reuters.

Once seen as a front-runner in the development of a coronavirus vaccine, the British team has been overtaken by U.S. drugmaker Pfizer Inc and partner BioNTech, whose shots are already being used in Britain and the United States.

Confusion has arisen over the best dosage. Data published earlier from the British team's Phase 3 trials showed efficacy was 62% for trial participants given two full doses, but a more robust 90% for a sub-group given first a half, then a full dose.

Krieger said Fiocruz would apply to Anvisa with a two-dose regimen, which, despite being less effective, was more widely tested, including in Brazil.

He said Fiocruz would be applying for a full approval with Anvisa, rather than an emergency use application. Pfizer, which is in talks to sell its vaccine to Brazil's federal government, has said the emergency use application is onerous.

Krieger said the institute would start filling and finishing 1 million doses per week in January, then ramp up to 3 million weekly doses in early February.

Fiocruz is licensed to receive supplies from AstraZeneca and eventually produce the vaccine locally. Brazil's federal government, which has ordered the AstraZeneca vaccine, expects to receive 100 million doses in the first half of 2021.

Brazilian President Jair Bolsonaro, one of the world's most prominent coronavirus skeptics, said over the weekend he was not worried about criticism over the speed of Brazil's vaccine rollout, saying he felt no pressure.

"Nobody pressures me for anything, I don't give a damn about it," he said in a video aired on CNN Brasil.

Bolsonaro, who caught the virus in July, has also said he will not take any COVID-19 vaccine, adding to growing vaccine skepticism in Brazil.

Brazil now has nearly 7.5 million confirmed cases, and 191,139 deaths from the virus since the outbreak began, according to data from the Health Ministry.

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