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(Recasts top, adds further comments from Fauci)
March 23 (Reuters) - AstraZeneca will publish
up-to-date results from its latest COVID-19 vaccine trial within
48 hours after U.S. health officials said the drugmaker's
analysis of the shot's efficacy may not have been based on all
the available data.
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, DIRECTOR OF THE U.S. NATIONAL INSTITUTE
OF ALLERGY AND INFECTIOUS DISEASES (NIAID) and COVID-19 MEDICAL
ADVISOR TO U.S. PRESIDENT JOE BIDEN
"The fact is this is very likely a very good vaccine."
"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 data that are analyzed in any given trial go through
what is called a data safety monitoring board, which is an
independent group of people who are experienced and look at the
data.
"When the data from the AZ trial that was conducted
predominately in the United States was analyzed by the DSMB
together with the company, what happened is that the company put
out a press release giving data and making some conclusions
about the efficacy.
"And the data safety monitoring board when they saw that
press release, they got concerned and wrote a rather harsh note
to them that was copied to me, saying that in fact they felt
that the data that was in the press release were somewhat
outdated and might in fact be misleading a bit and wanted them
to straighten it out,” Fauci told ABC News' "Good Morning
America."
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 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 data 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.
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 (from Moderna and Pfizer/BioNTech
."
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 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
"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)
