Tuesday, March 23, 2021 – 08:08
The company may have provided outdated data in its new US macro trial to seek clearance
Coronavirus Spain today, breaking news
AstraZeneca ensures that its vaccine is effective in those over 65 years and does not carry a risk of thrombi
AstraZeneca may have provided an incomplete version of the efficacy data for its Covid-19 vaccine in its new large-scale trial in the US, a US health agency said Tuesday, in a new setback for the British vaccine.
The news comes just one day after the drugmaker’s interim data showed better-than-expected results in its trial, and casts doubt on its plan to seek US emergency use authorization in the coming weeks.
The vaccine developed with the Oxford University It is 79% effective in preventing symptomatic disease, according to a large trial conducted in the United States, Chile, and Peru, and more importantly, it does not pose an increased risk of blood clots, according to the data.
The Data Security Monitoring Board (DSMB) has expressed “concern that AstraZeneca may have included outdated information from that trial, which may have provided an incomplete view of the efficacy data,” said the National Institute of Allergy and Infectious Diseases (NIAD) from the US in a statement.
NIAID is led by the US 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 effectiveness data and ensure that the most accurate and up-to-date effectiveness data is made public as soon as possible,” he added.
AstraZeneca has not yet responded to the allegations.
An attempt to regain confidence
Licensing 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 , the AstraZeneca vaccine has raised doubts about its efficacy, dosing regimen, and possible side effects. More than a dozen European countries, including Germany , France Y Espaa, stopped use of the vaccine in early March after several cases linked it to a rare blood clotting disorder.
The data from the most recent trial, which have not yet been reviewed by independent researchers, have restored confidence in the British vaccine.
Fauci, who is also a medical adviser to the president of the United States, Joe Biden, said Monday that the US trial had found no evidence of causation in the rare blood clots. The most recent data is based on 141 infections among 32,449 participants.
Injection has also been at the center of a growing conflict between Brussels Y London by so-called vaccine nationalism after a series of supply setbacks in Europe.
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George is Digismak’s reported cum editor with 13 years of experience in Journalism