(Adds Pfizer comments)
By Pedro Fonseca
RIO DE JANEIRO, Dec 17 (Reuters) - Pfizer is
encountering difficulty in registering its COVID-19 vaccine for
emergency use in Brazil due to the level of detail required by
the regulator, Health Minister Eduardo Pazuello said on
Thursday.
The health minister's comments could raise tensions with
Pfizer, whose vaccine is already being used in Britain and the
United States. They will also fuel concerns from critics who
argue that Brazil's vaccine rollout is progressing too slowly,
just as the virus roars back to life.
Vaccines are seen as crucial to ending the outbreak in
Brazil, its death toll second only to the United States at more
than 180,000 people. President Jair Bolsonaro, already under
fire for his handling of the pandemic, is one of the world's
most prominent COVID-19 skeptics, and has said he will not take
any vaccine.
Addressing lawmakers on Thursday, Pazuello said he spoke
with Pfizer's country manager on Sunday and directed him to meet
with officials from health regulator Anvisa. After meeting
Anvisa officials, the manager told the health minister that he
had expected the emergency use process to be less onerous,
Pazuello said.
"'I thought it was simpler, but the agency is very
detailed,'" Pazuello quoted the unnamed Pfizer executive as
saying.
Pfizer Brazil's country manager, Carlos Murillo, could not
immediately be reached for comment. In a series of statements on
Thursday, Pfizer said it could not comment on talks with the
government.
Its statements confirmed that Anvisa had made specific
requests that required more time. As a result, it said that
seeking full regulatory approval for its vaccine - rather than a
more onerous emergency use authorization - was the fastest
course of action at this time.
It said the Anvisa requirement for specific country data was
more onerous than other regulatory agencies, which were happy to
analyze the trial information as a whole.
Pazuello said Pfizer had presented a variety of demands in
order to close the deal, including a waiver of liability. "We
are thinking of accepting," Pazuello said of the demands.
In its statements Pfizer said many countries had agreed to
waive liability, including in Latin America.
Anvisa confirmed that Pfizer had yet to apply to register
its vaccine. It said that information provided by Pfizer was
"not the complete data necessary to judge the safety, efficacy
and quality of a vaccine for registration."
The regulator added that so far no vaccine producer had
applied for full registration or approval for emergency use.
A source with knowledge of Pfizer's position said it was
only going to apply for an emergency use authorization once the
Brazilian government signed a contract to buy its vaccine.
Brazil's federal government has repeatedly changed the date
by which it expects to start inoculations. After a lull of a few
months, infections are rising again sharply, hitting a fresh
daily record on Wednesday of 70,000 new cases.
Brazil expects to receive some 24 million COVID-19 vaccines
by January, Pazuello said.
He said Brazil expected Pfizer to provide 500,000 of those
doses next month, China's Sinovac to provide 9 million
doses and AstraZeneca to provide 15 million doses.
Brazil expects to reach 37.7 million vaccine doses by
February, with another 31 million doses arriving in March, the
minister added.
(Reporting by Pedro Fonseca
Writing by Stephen Eisenhammer and Gabriel Stargardter
Editing by Brad Haynes and Howard Goller)
Astrazeneca (AZN)
