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March 23 (Reuters) - AstraZeneca may have used
outdated information in the results of a large-scale COVID-19
vaccine trial, a U.S. health agency said on Tuesday, casting
fresh doubt on the efficacy of the shot and its potential U.S.
rollout.
The surprise public rebuke from federal health officials
follows the release on Monday of interim data from the drugmaker
showing better-than-expected results from the U.S. trial that
were seen as a scientific counter to concerns that have dogged
the vaccine since late last year.
The following are reactions to the latest developments.
ASTRAZENECA STATEMENT
"The numbers published yesterday were based on a
pre-specified interim analysis with a data cut-off of 17
February.
"We have reviewed the preliminary assessment of the primary
analysis and the results were consistent with the interim
analysis. We are now completing the validation of the
statistical analysis.
"We will immediately engage with the independent data safety
monitoring board (DSMB) to share our primary analysis with the
most up to date efficacy data. We intend to issue results of the
primary analysis within 48 hours."
DR ANTHONY FAUCI, COVID-19 MEDICAL ADVISOR TO U.S. PRESIDENT
JOE BIDEN
"This (is) likely a very good vaccine."
But the data and safety monitoring board "got concerned"
that the data in AstraZeneca's public statement "were somewhat
outdated and might in fact be misleading a bit," Fauci told ABC
News' "Good Morning America" programme.
EMER COOKE, HEAD OF THE EUROPEAN MEDICINES AGENCY
"The trials point to greater efficacy than what we actually
observed in the previous trials that we examined," Cooke told
members of the European Parliament.
"The company has promised to provide us with (data) and we
will adjust our assessment if there is any new information that
needs to be taken into account."
IAN JONES, PROFESSOR OF VIROLOGY AT UNIVERSITY OF READING
"The NIAID (National Institute of Allergy and Infectious
Diseases) statement is not clear on the actual data that is
causing the disquiet.
"I think it is generally accepted that the early trial data,
while positive, did suffer from a communication issue which
failed to get across a single clear message.
"But any concerns that date from that time would have surely
been surpassed by the data now available from actual usage,
which shows an excellent safety profile and the prevention of
severe disease.
"That is, in effect, a much bigger trial and it is that data
that should be up front for consideration by bodies who have yet
to approve its use."
STEPHEN EVANS, PROFESSOR OF PHARMACOEPIDEMIOLOGY, LONDON
SCHOOL OF HYGIENE & TROPICAL MEDICINE
"It is not unknown for a DSMB (Data Safety Monitoring Board)
to disagree with investigators over interpretation of trial
results.
"It is usually done in private, so this is unprecedented in
my opinion."
"One explanation might well be that this trial is currently
being conducted when there is a large amount of a new variant
about more recently, and, as might be expected, the efficacy
against that variant might be less, so more recent data shows
reduced efficacy. Of course 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."
PETER KREMSNER, PROFESSOR AT UNIVERSITY HOSPITAL IN
TUEBINGEN, GERMANY
"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."
DR STEPHEN GRIFFIN, ASSOCIATE PROFESSOR IN THE SCHOOL OF
MEDICINE, UNIVERSITY OF LEEDS
"Naturally, the news yesterday was taken in good faith and
the issues raised by the DSMB may be a mere technicality, yet
this won’t be clear until we have full disclosure. Nevertheless,
we must ensure that issues such as this are dealt with
appropriately and that idle speculation is not seized upon by
groups seeking to undermine faith in vaccination programmes."
CITI
"DSMB (Data and Safety Monitoring Board) externalisations of
concerns are deeply unusual for multinational pharma companies
and suggest an extraordinary high level of friction between the
DSMB and the sponsor."
"The implication of the DSMB feedback is that AZN may have
overstated the efficacy of the vaccine in at least a subgroup of
the patients."
NEIL WILSON, CHIEF MARKET ANALYST AT MARKETS.COM
"More doubts won't do the vaccine any favour – another PR
problem that will cost lives.
"This will not do any favours for getting this shot into
people’s arms – it's not just the rollout by government, it’s
people’s willingness to get it. And on that note Europe sits on
large stockpiles of the Astra vaccine as countries cannot get
the jab into arms."
(Compiled by Reuters staff;
Editing by Alison Williams)
