(Reuters) – AstraZeneca Plc may have given an incomplete overview of the efficacy data on its large-scale COVID-19 vaccine in the U.S. trial, a U.S. health agency said Tuesday in a new setback for the shot.
The news comes just one day after the drugmaker’s interim data showed better-than-expected results from the trial and doubts about his plan to seek US vaccine approval for the vaccine in the coming weeks.
The vaccine developed with Oxford University was 79% effective in preventing symptomatic diseases in a large trial in the United States, Chile and Peru, and according to the data, there was no significant risk for blood clots.
The Data Safety Monitoring Board (DSMB) “expressed concern that AstraZeneca may have included outdated information from the trial, which may have given an incomplete overview of the efficacy data”, the US National Institute of Allergy and Infectious Diseases (NIAID) said in a statement.
NIAID is led by the American expert in infectious diseases, Anthony Fauci, and is part of the National Institutes of Health.
“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.
AstraZeneca did not immediately respond to a request for comment.
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.
The AstraZeneca shot is a milestone in the fight against the COVID-19 pandemic when it emerged as a competitor for vaccine last year, and has been questioned by doubts about its efficacy, dosing regimen and possible side effects. 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 experimental data, which has yet to be reviewed by independent researchers, would be credible to the British shot after the results of earlier separate studies raised questions about the robustness of the data.
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.
The latest data is based on 141 infections among 32,449 participants.
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; Edited by Edwina Gibbs