(Reuters) – AstraZeneca Plc may have provided an incomplete view of its COVID-19 vaccine efficacy data from a large-scale US trial, a US health agency said on Tuesday. reverse for the vaccine.
The news comes just a day after interim data from the drugmaker showed better-than-expected results from the trial and casts doubt on its plan to seek U.S. emergency use authorization for the vaccine in the coming weeks. .
The vaccine developed with the University of Oxford was 79% effective in preventing symptomatic disease in a large trial in the United States, Chile and Peru and, more importantly, did not pose an increased risk of blood clots, according to the data. .
The Data Safety Monitoring Board (DSMB) has “expressed concern that AstraZeneca may have included outdated information from that trial, which may have provided an incomplete view of the efficacy data,” said the National Institute of Allergy and Disease. Infectious Diseases (NIAID) in a statement.
The NIAID is led by the 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 the efficacy data and ensure that the most accurate and up-to-date efficacy data is released as soon as possible,” he said.
AstraZeneca did not immediately respond to a request for comment from Reuters.
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.
Hailed as a milestone in the fight against the COVID-19 pandemic when it emerged as a vaccine contender last year, the AstraZeneca injection has been haunted by doubts about its efficacy, dosage regimen, and potential side effects.
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 data from the most recent trial, which has not yet been reviewed by independent researchers, was established to give credence to the British shooting after results from earlier separate late-stage studies raised questions about the robustness of the data.
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.
The most recent data was based on 141 infections among 32,449 participants.
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; Edited by Edwina Gibbs