US health agency questions data on AstraZeneca COVID-19 vaccine

(Reuters) – AstraZeneca may have used “obsolete information” in the results of a large-scale trial of COVID-19 vaccine, a US health agency said on Tuesday questioning the shooting, its potential deployment in the United States and plunged its developers, once again, into controversy.

Highly unusual disapproval from federal health authorities comes just a day after the drug manufacturer’s provisional data showed better-than-expected results from the U.S. trial, which had been seen as a scientific counter to concerns. who have been chasing the shooting since late last year.

According to the data, the vaccine developed with the University of Oxford, associated, had 79% efficacy in the prevention of symptomatic diseases. It was also 100% effective against severe or severe forms of the disease and hospitalization, and did not present an increased risk of blood clots.

The Data Safety Monitoring Board (DSMB), an independent committee overseeing the trial, “has expressed concern that AstraZeneca may have included obsolete information from this trial, which may have provided an incomplete view of the efficacy data.” the United States National Allergy Institute. and infectious diseases (NIAID) said in a statement bit.ly/3scE3ji released after midnight in the United States.

“We urge the company to work with the DSMB to review performance data and ensure that the most up-to-date and accurate performance data is made public as quickly as possible,” he said, adding that the DSMB had informed AstraZeneca of the their concerns.

AstraZeneca did not immediately respond to Reuters’ request for comment.

Its shares fell 1% in early morning trading.

NIAID is led by American infectious disease expert Anthony Fauci and is part of the National Institutes of Health. The DSMB is organized by NIAID, according to a document describing the design of the test. The role of the board is to provide study oversight and evaluate clinical data to ensure the safe and ethical conduct of the study.

Authorization and guidelines for the use of the vaccine in the United States will be determined after a thorough review of the data by independent advisory committees, the statement added.

DOUBTS REALIZED

Although it was considered a milestone in the fight against the COVID-19 pandemic when it was introduced as a vaccine aspirant last year, the AstraZeneca shooting has seen a steady stream of questions about its effectiveness, the dosing regimen and possible side effects.

More than a dozen European countries stopped using the vaccine earlier this month after reports linked it to a rare blood clotting disorder in a very small number of people.

Germany and France resumed vaccinations after the EU drug regulator said last week it was safe, but an opinion poll on Monday showed Europeans remained skeptical about its safety.

Fauci, who also serves as chief medical adviser to U.S. President Joe Biden, said Monday that the U.S. trial found no clues about the rare blood clots.

Before worrying about the blood clot, there were also previous separate studies in the final phase, led by the University of Oxford, associate, which had raised doubts about its dosing regimen and the lack of data on its effectiveness for to the elderly.

The latest data, which has not yet been reviewed by independent researchers, was based on 141 infections among 32,449 participants.

Analysts had also noted AstraZeneca’s achievement of producing strong test data in a context of more infectious variants spreading to the United States and other countries.

The AstraZeneca vaccine, which is already widely used outside the United States, is considered crucial in dealing with the spread of COVID-19 worldwide, as it is easier and cheaper to transport than rival shots.

Conditional marketing or emergency use authorization has been granted to more than 70 countries. Many countries are relying heavily on ending the pandemic and several state leaders have taken the plunge to increase confidence in the vaccine, including South Korean President Moon Jae-in, who received it on Tuesday.

The shooting has also been at the center of a growing conflict between Brussels and London over so-called vaccine nationalism following a series of supply setbacks in Europe.