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(Adds Pfizer statement, Argentina emergency use approval)
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 under way 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. Brazil's
government has given a best-case-scenario date of Jan. 20 for
AstraZeneca vaccinations to begin.
On Wednesday, AstraZeneca said Argentina's regulator
approved its vaccine for emergency use in the country.
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 1,111 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.
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.
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, officials have said nationwide vaccinations
could, at the earliest, begin on Jan. 20.
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.
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)
