miércoles, 24 de marzo de 2021

AZ: "outdated information"...siembra dudas en NIAID sobre vacuna COVID-19


A recent study showing the Oxford AstraZeneca vaccine was highly effective may have used "outdated information" US federal health officials have now alleged.

Hours after the UK-Swedish drug giant reported its Covid-19 vaccine provided strong protection among adults, the National Institute of Allergy and Infectious Diseases (NIAID) said it was worried the trial results have given only a partial picture.


NIAID Statement on AstraZeneca Vaccine

The statement immediately threatened to overshadow results that had been viewed as good news for the company after public doubts over its vaccine, and mire the firm in fresh controversy.

The NIAID said its safety and monitoring board “was concerned by information released by AstraZeneca on initial data from its Covid-19 vaccine clinical trial”.

The board “expressed concern that AstraZeneca may have included outdated information from that trial, which may have provided an incomplete view of the efficacy data”.

We urge the company to work with [the board] to review the efficacy data and ensure the most accurate, up-to-date efficacy data be made public as quickly as possible."

"This is likely a very good vaccine," Anthony Fauci, the US president's medical adviser and NIAID director, told ABC News' "Good Morning America" programme on Tuesday morning. "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."

NIAD on Tuesday said: "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."

The AstraZeneca vaccine has been heralded as a vital part of efforts to beat the coronavirus pandemic, with a low cost and ease of storage that should make it the global workhorse of jabs.

The World Health Organisation, UK health authorities and the European Medicines Agency have all voiced support for it.

But public confidence in America and Europe was dented by early questions over trial data and then by reports of unusual blood clots among those who had taken it.

Monday's results from a study of 30,000 people showing that the vaccine was 79 per cent effective at preventing symptomatic cases, including in older adults had been hoped to start rebuilding confidence in the shot.

Researchers found there were no severe illnesses or hospitalisations among vaccinated volunteers, compared with five such cases in participants who received dummy shots.

AstraZeneca's shot is still not authorised for use in America and the company has had tensions with US regulators.

Reports emerged late last year that US officials had become angered at the firm's failure to tell them it had paused trials after a volunteer fell ill.

The incident, along with other alleged communication blunders, damaged the UK company's standing with US regulators and appeared to slow the vaccine's development, according to the New York Times.


Ultima hora: 

AstraZeneca's COVID-19 Vaccine Trial Data Might Have Included Outdated Information, US Agency Says

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