(Adds comments by health official and Bolsonaro, background,
details)
By Pedro Fonseca
RIO DE JANEIRO, Dec 28 (Reuters) - 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.
(Reporting by Pedro Fonseca in Rio de Janeiro
Writing by Gabriel Stargardter
Editing by Brad Haynes and Matthew Lewis)