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FRANKFURT/LONDON, March 22 (Reuters) - AstraZeneca's
COVID-19 vaccine developed with Oxford University was 79%
effective in preventing symptomatic illness in a large trial in
Chile, Peru and the United States, the company said on Monday,
paving the way for it to apply for U.S. approval.
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.
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)
