(Adds latest COVID-19 numbers)
By Gabriel Stargardter and Eduardo Simões
RIO DE JANEIRO/SAO PAULO, 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 the
South American country was forced into making regulatory
concessions to speed up its lagging immunization program.
Britain on Wednesday 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.
But it also highlights the problems Latin America's biggest
country has had in procuring and utilizing vaccines that will be
crucial to ending the world's second-most deadly coronavirus
outbreak.
President Jair Bolsonaro, a prominent coronavirus skeptic
who has said he will not take any COVID-19 vaccine, is under
growing pressure to speed up Brazil's rollout, as regional peers
Mexico, Chile and Argentina have already begun immunizations.
On Wednesday, AstraZeneca said Argentina's regulator
approved its vaccine for emergency use there.
Brazil's government has given a best-case-scenario date of Jan.
20 for AstraZeneca vaccinations to begin.
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.
It also said that it had agreed to tweak certain emergency
use application requirements that Pfizer Inc had
complained were overly onerous.
The federal government's dispute with Pfizer, whose vaccine
is already being used in Britain and the United States, led
critics to decry needless bureaucratic hurdles just as the virus
roars back to life. Brazil recorded 1,194 deaths from COVID-19
on Wednesday, the highest number for one day since Sept. 1.
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's complaints about the process had forced
the government onto the defensive 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.
However, the government also pledged to improve dialogue
with Pfizer.
Its new stance appears to be bearing fruit.
On Wednesday, Pfizer said Anvisa had suggested 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.
(Reporting by Eduardo Simoes in Sao Paulo and Ricardo Brito in
Brasilia
Writing by Gabriel Stargardter
Editing by Brad Haynes and Alistair Bell)