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LONDON, March 23 (Reuters) - AstraZeneca will
release the most up-to-date results from its latest COVID-19
vaccine trial within 48 hours after U.S. health officials
publicly criticised the drugmaker for using outdated information
in a press release earlier this week.
AstraZeneca said results published on Monday were based on
an interim analysis of data through Feb. 17. The company said on
Tuesday it would "immediately engage" with the independent panel
monitoring the trial to share its primary analysis using the
most up-to-date efficacy data.
The move comes after the National Institute for Allergy and
Infectious Diseases said the monitoring board charged with
ensuring the safety and accuracy of the trial had expressed
concern that the company may be giving an "incomplete" picture
of the shot's effectiveness.
"This is likely a very good vaccine," Dr Anthony Fauci, U.S.
President Joe Biden's COVID-19 medical adviser and National
Institute of Allergy and Infectious Diseases (NIAID) director,
told ABC News' "Good Morning America" program. "If you look at
it, the data really are quite good but when they put it into the
press release it wasn't completely accurate."
The public rebuke marks the latest setback for the vaccine,
which was initially hailed as a milestone in the fight against
the COVID-19 pandemic but which has been dogged by questions
over its effectiveness and possible side effects.
AstraZeneca said it had reviewed the preliminary assessment
of the primary analysis and found it to be consistent with the
interim report.
Its shares were down over 1% in London trading.
According to the data AstraZeneca made public on Monday the
vaccine, developed with Oxford University, was 79% effective in
preventing symptomatic illness in the large trial that also took
place in Chile and Peru. It was also 100% effective against
severe or critical forms of the disease and hospitalisation, and
posed no increased risk of blood clots.
The renewed doubts about the vaccine's efficacy coincide
with its rollout in dozens of countries worldwide and clouds the
timeline for its emergency use authorization in the United
States.
"This is indeed an extraordinary act. The negative reports
about this vaccine do not stop, although my assessment is that
it is well tolerated and safe, but clearly less effective than
the two mRNA vaccines," Peter Kremsner, from the University
Hospital in Tuebingen, Germany.
Rival vaccines from Pfizer and Moderna that
use so-called mRNA technology produced efficacy rates of around
95% each, far above the 50% benchmark set by global regulators.
The DSMB is organised by NIAID, and its role is to provide
study oversight and evaluate clinical data to ensure safe and
ethical conduct of the study. Fauci heads the NIAID, which is
part of the National Institutes of Health.
DOUBTS RAISED
AstraZeneca's COVID-19 shot has faced questions since late
last year when the drugmaker and Oxford University published
data with different efficacy readings due to a measurement
error.
Later analysis suggested the dosing interval rather than the
amount of dose administered was responsible for the difference.
Confidence in the vaccine took a further hit this month when
more than a dozen countries, mostly in Europe, temporarily
suspended the shot after reports linked it to a rare blood
clotting disorder in a very small number of people.
The European Union's drug regulator said last week it was
safe but an opinion poll on Monday showed Europeans remained
sceptical about its safety.
The latest data, which has yet to be reviewed by independent
researchers, was based on 141 infections among 32,449
participants.
Analysts had noted AstraZeneca's achievement of producing
strong trial data against a backdrop of more infectious variants
spreading in the United States and other countries.
Stephen Evans, a pharmacoepidemiology professor at London
School of Hygiene & Tropical Medicine, said the up-to-date data
request may have to do with efficacy readings from recent
infections which may include new variants and thus lower
protection rates.
"The other vaccines may also show such reduced efficacy and
we don’t know by how much. It does not leave me concerned
particularly unless they had found a safety issue that was being
hidden, which does not appear to be the case."
The AstraZeneca vaccine is seen as crucial in tackling the
spread of COVID-19 across the globe because it is easier and
cheaper to transport than rival shots.
It has been granted conditional marketing or emergency use
authorization in more than 70 countries. Many countries are
relying heavily on it to end the pandemic, and several state
leaders have taken the shot to boost confidence in the vaccine
including South Korea's President Moon Jae-in who received it on
Tuesday.
(Reporting by Miyoung Kim in Singapore; Additional reporting by
Shubham Kalia in Bengaluru, Ludwig Burger in Frankfurt and Kate
Kelland in London; Editing by Edwina Gibbs and Josephine Mason)
