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UPDATE 1-QUOTES-U.S. health agency questions AstraZeneca's COVID-19 vaccine trial data

(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to them that was copied to me, saying that in fact they felt that the data that was in the press release were somewhat outdated and might in fact be misleading a bit and wanted them to straighten it out,” Fauci told ABC News’ “Good Morning America.”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)

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