The vaccine was also 100% effective against severe or critical
disease and hospitalisation, and was safe, the partners said on
Monday, releasing results of the late-stage human trial study of
more than 32,000 volunteers across all age groups.
The data will give credence to the British shot after results from
earlier, separate late-stage studies raised questions about the
robustness of the data.
It will also help to allay safety concerns that have disrupted its
use in the European Union after a small number of reports of rare
blood clots in people who received the vaccine.
After briefly halting its use, many European countries have resumed
using the shot in their inoculation programmes after a regional
regulator said it was safe, while several country leaders are also
taking the vaccine to boost confidence.
AstraZeneca said an independent safety committee conducted a
specific review of the blood clots in the U.S. trial, as well as
cerebral venous sinus thrombosis (CVST), which is an extremely rare
blood clot in the brain, with the help of an independent
neurologist.
The London-listed company said the panel found "no increased risk of
thrombosis or events characterised by thrombosis among the 21,583
participants receiving at least one dose of the vaccine. The
specific search for CVST found no events in this trial."
"These results are great news as they show the remarkable efficacy
of the vaccine in a new population and are consistent with the
results from Oxford-led trials," Andrew Pollard, who runs the Oxford
Vaccine Group, said.
AstraZeneca said it was preparing to submit the data to the U.S.
Food and Drug Administration and for a launch in the United States
should it win Emergency Use Authorization.
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University of Oxford professor
Sarah Gilbert told BBC radio that work to
prepare the submission will take a few weeks.
The efficacy read-out was above a rate of about
60%, cited by the European Union's drugs
regulator in its December recommendation.
It was, however, in line with the maximum efficacy found by
Britain's Medicines and Healthcare products Regulatory Agency (MHRA),
based on cases with a three-month gap between the first and the
second dose.
In the trial, participants received either two standard doses of the
Oxford-AstraZeneca vaccine or a placebo vaccine, at a four-week
interval.
Amongst participants in the interim analysis, about 79% were
white/Caucasian, 8% black/African American, 4% native American and
4% Asian, and 22% of participants were Hispanic, the company said.
About 20% of participants were 65 years and over, and approximately
60% had co-morbidities associated with an increased risk for
progression of severe COVID-19, such as diabetes, severe obesity or
cardiac disease.
(Reporting by Ludwig Burger in Frankfurt, Pushkala Aripaka and
Muvija M in Bengaluru; Editing by Josephine Mason, Mark Potter,
Sherry Jacob-Phillips and Edmund Blair)
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