(Reuters) – AstraZeneca Plc could have provided an incomplete picture of the efficacy data of its COVID-19 vaccine in a large-scale US study, a US health agency said on Tuesday in a new obstacle to the shooting.
The news comes just a day after the doctor’s interim data showed better results than expected from the study and questioned his plan to apply for US 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 study conducted in the United States, Chile and Peru and essentially does not present an increased risk of blood clots, according to the data.
The Data Safety Monitoring Committee (DSMB) has expressed concern that AstraZeneca could have included outdated information from this study, which could have provided an incomplete picture of the efficacy data, ”said the National Allergy Institute. and Infectious Diseases (NIAID) in the United States. a declaration.
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 DSMB to review efficacy data and ensure that the most accurate, up-to-date efficacy data is made public as soon as possible,” he said.
AstraZeneca did not immediately respond to Reuters’ request for comment.
The authorization and guidelines for the use of the vaccine in the United States will be established 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 last year as a vaccine candidate, AstraZeneca’s shooting has been hampered by doubts about its effectiveness, dosing regimen and possible 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 latest data from the studies, which have not yet been reviewed by independent researchers, should have given credence to British photography after the results of previous, separate, late-stage studies raised questions about the robustness of the data.
Fauci, who is also chief medical adviser to US President Joe Biden, said on Monday that the US trial had found no indication of rare blood clots.
The latest data was based on 141 infections in 32,449 participants.
The shooting was also at the center of a growing conflict between Brussels and London over so-called vaccine nationalism, following a series of supply failures in Europe.
Miyoung Kim’s report to Singapore; Additional reporting by Shubham Kalia in Bengaluru; Edited by Edwina Gibbs