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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.
Health regulator Anvisa confirmed that Pfizer had yet to
apply to register its vaccine. In a statement, Anvisa 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.
The snag comes as pressure rises in Brazil over the delay in
rolling out a vaccine as other countries begin immunizations.
Brazil's federal government has repeatedly changed the date
by which it expects to start inoculations needed to bring the
outbreak under control. After a lull of a few months, infections
are rising again sharply, hitting a fresh daily record on
Wednesday.
Speaking to an audience of senators on Thursday morning,
Pazuello said Pfizer had presented a variety of demands in order
to close the deal to supply the vaccine to Brazil, including a
waiver of liability.
"We are thinking of accepting," Pazuello said of the
demands.
Pfizer said in a statement it was in talks with the Health
Ministry and that many countries had agreed to waive liability.
It did not comment on the registration process with Anvisa.
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
Editing by Brad Haynes and Howard Goller)
