(Reuters) – AstraZeneca may have used ‘outdated information’ in the results of a large-scale COVID-19 vaccine test, a US health agency said on Tuesday, casting doubt on the shot, its potential deployment in the US and its developers plunged, once again into controversy.
The highly unusual rebuke from federal health officials comes just one day after the drugmaker’s interim data showed better-than-expected results from the U.S. trial, which was seen as a scientific contradiction to the concerns that have plagued the shot since late last year.
The vaccine, developed with partner Oxford University, was 79% effective in preventing symptomatic disease in the large trial that also took place in Chile and Peru. It was also 100% effective against severe or critical forms of the disease and hospitalization, and did not involve any increased risk of blood clots.
The Data Security Monitoring Board (DSMB), an independent committee overseeing the trial, ‘expressed concern that AstraZeneca may have included outdated information from the trial, which may have given an incomplete overview of the effectiveness data’, the US National Institute of Allergy and Infectious Diseases (NIAID) said in a statement that bit.ly/3scE3ji was released after midnight in the United States.
“We call on the company to work with the DSMB to review the efficiency data and ensure that the most accurate, most recent efficiency data is released as soon as possible,” he said, adding that the DSMB informed AstraZeneca posed of his concern. .
AstraZeneca did not immediately respond to a request for comment.
Its shares fell 1% in the early morning trading.
NIAID is led by the American expert in infectious diseases, Anthony Fauci, and is part of the National Institutes of Health. The DSMB is organized by NIAID according to a document outlining the pilot design. The role of the council is to provide study supervision and evaluate clinical data to ensure safe and ethical conduct of the study.
Authorization and guidelines for the use of the vaccine in the United States will be determined after thorough review of the data by independent advisory committees, the statement said.
DOUBLE IS AFFECTED
Although considered a milestone in the fight against the COVID-19 pandemic when it emerged as a rival for vaccine last year, the AstraZeneca shot has raised a constant stream of questions about its effectiveness. thereof, the dosage 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 EU drug regulator said it was safe last week, but a poll on Monday showed Europeans remain skeptical about its safety.
Fauci, who also serves as medical adviser to U.S. President Joe Biden, said Monday the U.S. trial found no indication of the rare blood clots at all.
Before the blood clot was delivered, there were also separate late-stage studies, conducted by partner Oxford University, that raised questions about the dosing regimen and the lack of data on its efficacy for the elderly.
The latest data, yet to be reviewed by independent researchers, were based on 141 infections among 32,449 participants.
Analysts also noted AstraZeneca’s performance in producing strong test data against the backdrop of more contagious variants spreading in the United States and other countries.
The AstraZeneca vaccine, which is widely used outside the United States, is considered important in tackling the spread of COVID-19 worldwide, as it is easier and cheaper to transport than competing shots.
Permission for conditional marketing or emergency use has been granted in more than 70 countries. Many countries are relying heavily on ending the pandemic, and several leaders have taken the opportunity to boost confidence in the vaccine, including South Korean President Moon Jae-in, who received it on Tuesday.
The shot was also at the center of a growing conflict between Brussels and London over so-called vaccine nationalism following a number of setbacks in Europe.
Reporting by Miyoung Kim in Singapore; Additional reporting by Shubham Kalia in Bengaluru and Ludwig Burger in Frankfurt; Edited by Edwina Gibbs and Josephine Mason