By Jenny Strasburg and Drew Hinshaw
LONDON -- The U.K. asked its medicines regulator to review
AstraZeneca PLC's Covid-19 vaccine for emergency-use approval,
while Europe's equivalent of the FDA said it could be more flexible
in how it reviews a handful of promising candidates.
The two moves accelerate a regulatory race on both sides of the
Atlantic, triggered by the recent publication of positive clinical
data for three different vaccine candidates. Two shots -- one from
Pfizer Inc. and Germany's BioNTech SE, and another from Moderna
Inc. -- showed to be more than 90% effective at preventing
symptomatic Covid-19 in large-scale human trials.
On Monday, AstraZeneca said the vaccine it has developed with
the University of Oxford showed to be as much as 90% effective, but
only among a small subset of subjects who received a lower first
dose of the two-shot regimen. In the other group of trial subjects
given two full doses, the vaccine showed 62% efficacy.
While that overall reading falls well short of the other two
vaccines, AstraZeneca said the results showed its shot was still
effective enough against the virus to provide protection and that
the company hoped for regulatory approval in Europe in coming
weeks, soon enough to potentially have the vaccine in use by
year-end.
The U.K. on Friday formally requested that the country's
Medicines and Healthcare products Regulatory Agency review the
AstraZeneca vaccine for emergency use in the country. Such
authorization depends on full safety and efficacy data that the
vaccine partners have yet to submit, U.K. officials said. The MHRA
hasn't provided a timeline for its review process.
Still, the British government said in a statement its request
"would mean potentially faster access to the vaccine for U.K.
patients," dependent on approval.
That sets up the U.S. and the U.K. as the two most likely
markets to get at least one of the three vaccines first, should
regulators ultimately approve any of them. Pfizer has already
submitted an approval application to both the Food and Drug
Administration in the U.S. and the British regulator.
European Union regulators, meanwhile, say they might need until
next year to assess the candidates.
The U.K. is in a transition period, through Dec. 31, in its
process to exit from the EU. That means medicine approvals are
still in most cases handled by the European Medicines Agency, that
bloc's top medicines regulator. But the U.K. retains the power to
authorize medicines for emergency use, and the government has said
it would do so if the MHRA signs off on a vaccine before the end of
the year.
The EMA has yet to receive an application from any of the
vaccine makers, officials there said, though it expects that in
coming days. It said it was willing to be more flexible in speeding
up its vaccine approval procedures. In a notice published Friday,
it invited drugmakers to contact the agency to discuss strategies
to quicken the review process.
The "EMA is ready to apply further flexibility, where it is
established that shortening of any other procedural step could have
an important public-health impact in dealing with the Covid-19
pandemic," the notice said.
An authorization of one of the front-runner candidates could
come "towards the end of this year at the earliest," a spokeswoman
at the agency said.
The FDA hasn't detailed an approval timeline, but executives and
officials expect it to be in a position to grant emergency-use
authorization for the Pfizer shot by the end of the year.
Moderna is expected to submit its vaccine for FDA review
soon.
U.S. clinical trials of AstraZeneca's shot were paused earlier
this year after a trial subject in Britain fell ill. Trials were
resumed after the FDA didn't find the vaccine was responsible for
that and another illness, though the agency couldn't rule out a
link either, a person familiar with the matter said at the
time.
That has set back the timeline for the U.S. trial, for which
AstraZeneca is still recruiting volunteers, as well as any
potential FDA review of the AstraZeneca vaccine.
The British request for regulatory review follows disclosure
this week from AstraZeneca about its so-called Phase 3 trials that
some analysts and health officials criticized as muddled and
confusing.
AstraZeneca didn't immediately disclose that the dosing
difference was the result of an early manufacturing mistake. The
subset that received the lower, more effective dosing included only
people under 55 years old -- a factor researchers said could have
contributed to the higher effectiveness.
AstraZeneca and Oxford said a peer-reviewed version of Monday's
results, with more data, will be published in the next week or so.
AstraZeneca executives also said they are planning a new study of
the half-dose regimen that would include people over 55.
AstraZeneca has also said it plans to discuss with the FDA the
possibility of altering its large-scale trials in the U.S. to add a
new segment of participants who would receive the
half-dose-full-dose combination that proved 90% effective in the
subset of trials reported this week.
Mene Pangalos, AstraZeneca's executive vice president for
biopharmaceuticals research and development, said in an interview
this week that a new study looking at over-55 subjects on the
half-dose regimen would take some time.
"We've got to set up the study, we've got to start recruiting,"
he said. He said the 62% efficacy shown in the larger group of
trial volunteers was enough to move forward with seeking
authorization.
"We just look at the worst-case scenario, which is the vaccine
is 62% effective -- it's still an effective vaccine," he said.
Write to Jenny Strasburg at jenny.strasburg@wsj.com and Drew
Hinshaw at drew.hinshaw@wsj.com
(END) Dow Jones Newswires
November 27, 2020 11:39 ET (16:39 GMT)
Copyright (c) 2020 Dow Jones & Company, Inc.
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