AstraZeneca Vaccine Trial Data Underscore Safety, Range of Efficacy -- Update
08 Dezember 2020 - 5:58PM
Dow Jones News
By Jenny Strasburg and Joseph Walker
LONDON -- Peer-reviewed data from late-stage human trials of a
Covid-19 vaccine developed by the University of Oxford and
AstraZeneca PLC reaffirmed the shot's strong safety results and
provided some additional evidence that halving the first of two
doses of the shot boosts its effectiveness.
AstraZeneca and Oxford said the data gave them confidence to ask
the U.K. and other countries for emergency-use authorization of the
shot, but said regulators will have to decide which dosing regimen
to approve. Last month, AstraZeneca and Oxford said trial data
showed the vaccine was between 62% and 90% effective, but that the
higher results were observed in a small subset of the wider
trial.
This subset received a half-sized initial dose followed by a
full second dose. The group was also all under 55 years old,
raising questions about whether the lower dosing would also be
effective in older subjects.
AstraZeneca and Oxford on Tuesday declined to say whether they
would ask regulators to approve the lower dose regimen, leaving
unclear whether any initial vaccine approval and rollout would be
limited to the less-effective regimen. The 62% effectiveness shown
in the majority of the trial participants is still better than what
health experts said was necessary to protect people against severe
Covid-19.
The publication of the data -- the first full peer-reviewed
results from any of the late-stage human trials disclosed so far by
the West's three leading vaccine makers -- comes on the day that a
vaccine developed by Pfizer Inc. and Germany's BioNTech SE was
being administered for the first time outside trials, in the U.K.
The country authorized the vaccine for emergency use last week.
It also coincided with a preliminary assessment by the Food and
Drug Administration on Tuesday showing the agency was satisfied
with the Pfizer shot's effectiveness and safety, paving the way for
a potential emergency use authorization in the U.S. in coming
days.
The FDA is also reviewing Moderna Inc.'s vaccine, with a verdict
expected shortly.
While those two vaccines have raced ahead of AstraZeneca's in
the U.S. regulatory process, much of the rest of the world is
betting on it. Oxford and AstraZeneca promised to provide many more
doses across a wider geographic footprint then either Pfizer or
Moderna.
The partners have also promised to provide the shot at cost,
making it the vaccine of choice for much of the developing
world.
Results from an ongoing U.S. study will likely be needed before
a potential approval in the U.S., said Menelas Pangalos,
AstraZeneca's head of biopharmaceutical research, citing
conversation with regulators at the FDA.
Write to Jenny Strasburg at jenny.strasburg@wsj.com and Joseph
Walker at joseph.walker@wsj.com
(END) Dow Jones Newswires
December 08, 2020 11:43 ET (16:43 GMT)
Copyright (c) 2020 Dow Jones & Company, Inc.
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