(Reuters) – AstraZeneca may have used “outdated information” in the results of a large-scale COVID-19 vaccine trial, a US health agency said on Tuesday, casting new questions about the injection, its potential US launch and sunk its developers. once again, in controversy.
The highly unusual reprimand from federal health officials comes just one day after interim data from the drug maker showed better-than-expected results from the US trial.
The vaccine developed with a partner from the University of Oxford was 79% effective in preventing symptomatic diseases in the large trial that also took place in Chile and Peru, according to the data. It was also 100% effective against severe or critical forms of the disease and hospitalization, and did not pose 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Board (DSMB), an independent committee overseeing the trial, has “expressed concern that AstraZeneca may have included outdated information from that trial, which may have provided an incomplete view of the efficacy data.” , the U.S. National Institute of Allergy 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 the efficacy data and ensure that the most accurate and up-to-date efficacy data is released as soon as possible,” he said, adding that the DSMB had informed AstraZeneca of its concerns. .
AstraZeneca did not immediately respond to a request for comment from Reuters.
Its shares fell 1% in morning trading.
The NIAID is led by the American infectious disease expert Anthony Fauci and is part of the National Institutes of Health. The DSMB is organized by NIAID, based on a document that describes the test design. The role of the board is to oversee the study and evaluate the clinical data to ensure the safe and ethical conduct of the study.
Authorization and guidelines for the vaccine’s use in the United States will be determined after a thorough review of the data by independent advisory committees, the statement added.
Although it was hailed as a milestone in the fight against the COVID-19 pandemic when it emerged as a vaccine candidate last year, the AstraZeneca injection has seen a constant stream of questions about its efficacy, dosage regimen, and potential 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 vaccines after the EU drug regulator said last week that 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 US President Joe Biden, said Monday that the US trial found no evidence of the rare blood clots.
Before the blood clot concerns, there were also earlier separate late-stage studies, conducted by the partner Oxford University, that had raised questions about its dosing regimen and a lack of data on its efficacy for older people.
The most recent 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 in producing robust test data in the context of more infectious variants spreading in the United States and other countries.
The AstraZeneca vaccine, already widely used outside of the United States, is considered crucial in addressing the spread of COVID-19 around the world because it is easier and cheaper to transport than rival vaccines.
It has been granted a conditional marketing authorization or emergency use in more than 70 countries. Many countries rely heavily on it to end the pandemic, and several state leaders have shot up to boost confidence in the vaccine, including South Korean President Moon Jae-in, who received it on Tuesday.
The injection has also been at the center of a growing conflict between Brussels and London over so-called vaccine nationalism after a series of supply setbacks in Europe.
Report of Miyoung Kim in Singapore; Additional information from Shubham Kalia in Bengaluru and Ludwig Burger in Frankfurt; Edwina Gibbs and Josephine Mason Editing