(Adds details on emergency use)
By Eduardo Simões and Ricardo Brito
SAO PAULO/BRASILIA, Dec 30 (Reuters) - 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 underway around the hard-hit region.
Brazil's health regulator Anvisa met with AstraZeneca Plc
representatives in the morning and 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.
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, leading critics
to decry bureaucratic hurdles just as the virus roars back to
life. Brazil recorded 1,111 deaths on Tuesday, 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.
TARGETING JANUARY
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, Health Ministry officials have said
nationwide vaccinations would begin Jan. 20 in a best-case
scenario.
Anvisa's press representatives declined to say when Fiocruz
would file its request for emergency use.
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.
AstraZeneca and Fiocruz did not immediately answer questions
on plans and timing for seeking regulatory approval.
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.
The U.K. approval may add to pressure on Anvisa to expedite
its own approval processes.
While some vaccines, such as Pfizer's COVID-19 shot, must be
supercooled 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.
(Reporting by Eduardo Simoes in Sao Paulo and Ricardo Brito in
Brasilia
Writing by Gabriel Stargardter and Jamie McGeever
Editing by Brad Haynes and Alistair Bell)