(Reuters) – AstraZeneca Plc may have provided an incomplete view of COVID-19 vaccine efficacy data from a large-scale trial in the United States, a U.S. health agency said Tuesday in a new setback for the shot.
The news comes just a day after provisional data from the drug maker showed better-than-expected results from the trial and calls into question its plan to apply for U.S. emergency use authorization for the vaccine in the coming weeks.
The vaccine developed with Oxford University was 79% effective in preventing symptomatic disease in a large trial in the United States, Chile, and Peru, and essentially did not increase the risk of blood clots, according to the data.
The Data Security Monitoring Board (DSMB) “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 US National Institute of Allergy and Infectious Diseases (NIAID). a statement.
NIAID is led by American infectious disease expert Anthony Fauci and is part of the National Institutes of Health.
“We urge the company to work with the DSMB to review efficacy data and ensure that the most up-to-date and accurate performance data is made public as quickly as possible,” he said.
AstraZeneca did not immediately respond to Reuters’ request for comment.
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.
Hailed as a milestone in the fight against the COVID-19 pandemic when it appeared as a vaccine aspirant last year, AstraZeneca’s shooting has been questioned about its effectiveness, dosing regimen and possible effects. secondary.
More than a dozen European countries, including Germany and France, stopped using the vaccine earlier this month after reports linked it to a rare blood clotting disorder in a very small number of people. .
The latest data from the trials, which have not yet been reviewed by independent researchers, were set to give credence to the British feature after the results of previous and separate studies in the final phase raised doubts about the robustness of the data.
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.
The latest data was based on 141 infections among 32,449 participants.
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.
Reports from Miyoung Kim to Singapore; Additional reports from Shubham Kalia to Bengaluru; Edited by Edwina Gibbs