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 The independent monitors are analyzing data from the 32,000-person
U.S. study to determine whether the vaccine is safe and effective.
If the results are positive and all goes well, the U.S. Food and
Drug Administration would review the data and issue the
authorization, Dr. Francis Collins, director of the National
Institutes of Health (NIH), said in an interview.
Collins estimates that the FDA would need about three weeks to
analyze the trial data, after which an expert advisory panel will
meet and vote on whether to recommend authorization.
"We expect data from our US Phase III trial to be available soon,
and we plan to file for emergency use authorization shortly
thereafter," AstraZeneca spokeswoman Michele Meixell said in a
statement.
Independent monitoring boards periodically review data during
clinical trials to make sure no safety problems crop up, and can
halt studies early if it determines a drug or vaccine is likely to
fail or is clearly going to be a success.
The AstraZeneca vaccine, developed with the University of Oxford,
has been authorized for use in the European Union and many countries
based on separate trial data. U.S. regulators have been waiting for
the U.S. data.
Several EU countries have halted administering the AstraZeneca
vaccine after reports from Denmark and Norway of possible serious
side effects, including bleeding and blood clots.
Asked about those issues, Collins said he has not personally seen
the data but has been "pretty reassured" by statements from European
regulators that the problems could be occurring by chance, and are
not related to the vaccine.
With so many people being vaccinated, Collins said, some are bound
to experience a blood clot around the same time they receive a
vaccine.
[to top of second column] |
 "It's not clear at all" that
people who receive the vaccine get blood clots
at an increased rate, Collins said, adding
"there may be a bit of an overreaction to
something that is unrelated to the vaccine
itself."
A World Health Organization expert said on
Monday he sees no association between reports of
blood clots and the AstraZeneca vaccine and
urged people not to panic.
Asked about the emergence of more contagious
viral variants that could evade vaccine
protection, Collins said studies so far suggest
that currently authorized vaccines from Pfizer
Inc, Moderna Inc and Johnson & Johnson will be
protective.
"We do not feel that we are in a difficult
situation that requires immediate action in the
U.S., but we've got to watch this really
closely," said Collins, a geneticist who has led
the NIH since 2009.
COVID-19 vaccine makers have already started
work on booster doses of their shots that
specifically target a concerning variant first
discovered in South Africa. Those would be ready
by the end of 2021 or early 2022.
It will not be clear until this summer or fall
whether a booster dose is necessary, Collins
said.
"I really hope that doesn't happen, but I think
we would be foolish not to plan for that just in
case, and so planning is happening," he said.
(Reporting by Julie Steenhuysen in Chicago and
Michael Erman in New York; Editing by Peter
Henderson and Bill Berkrot)
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