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LONDON / CHICAGO – AstraZeneca will release updated results of its major 2019 U.S. coronavirus disease (COVID-19) vaccine trial within 48 hours after health officials publicly criticized the drug maker for use “outdated information” to show how well immunization was working.
The rare public reprimand marks the latest setback for the vaccine once hailed as a milestone in the fight against the COVID-19 pandemic that has since been haunted by questions about its effectiveness and potential side effects.
AstraZeneca said the results it released Monday showing the vaccine showing 79% efficacy were based on an interim analysis of data through February 17, and that it would now “immediately interact” with the independent panel that monitors the essay to share your full analysis.
The Britain-based drugmaker said on Tuesday it had reviewed the preliminary assessment of its full or primary analysis and found it to be consistent with the interim report.
But Washington Post reported that the data monitoring panel told federal officials that they had been working with the company through March, had seen data showing the vaccine could be 69% to 74% effective, and had “strongly recommended” AstraZeneca to include that information in your public statement.
AstraZeneca shares fell 1.8% in London trading.
The US National Institute of Allergy and Infectious Diseases (NIAID) said Monday that the independent monitoring panel had expressed concern that the company may have included outdated data that gave an incomplete picture of the injection’s effectiveness.
NIAID Director Dr. Anthony Fauci called the problem a truly unfortunate unforced error.
“This sort of thing does … more than cast some doubt on vaccines and can contribute to hesitation,” he told ABC’s “Good Morning America.”
“The data is actually pretty good, but when they put it in the press release it wasn’t entirely accurate,” he said.
In addition to the 79% efficacy in stopping symptomatic disease in the trial conducted in the United States, Chile, and Peru, data reported Monday also showed that the injection was 100% effective against severe or critical forms of the disease and did not raise any increase. risk of blood clots.
Dr. Larry Corey, co-director of the US Coronavirus Vaccine Prevention Network, which helped design the AstraZeneca US trial, said the reprimand from the monitoring panel was something that there was not. seen before. Virologist at the Fred Hutchinson Cancer Research Center in Seattle praised the panel for speaking out and said it showed that the system of checks and balances worked.
A US-based researcher who was not authorized to speak publicly said AstraZeneca was not mistaken in publishing an analysis that it had described as tentative and expressed concern about the public controversy.
“It’s a bit like shooting yourself in the foot, because science is good,” the person said.
‘NEGATIVE REPORTS ‘
New questions about the efficacy of the injection coincide with its launch in dozens of countries and cloud the timeline for its possible authorization for emergency use in the United States.
“This is indeed an extraordinary act. The negative reports on this vaccine do not stop, although my assessment is that it is well tolerated and safe, but clearly less effective than the two mRNA vaccines, ”said Peter Kremsner, University Hospital of Tuebingen, Germany.
Pfizer / BioNTech and Moderna vaccines that use messenger RNA (mRNA) technology to elicit an immune response had efficacy rates of around 95% in their pivotal clinical trials, well above the 50% benchmark set by global regulators. .
AstraZeneca’s COVID-19 injection has faced questions since late last year when the drugmaker and the University of Oxford published data from a previous trial with two different efficacy readings as a result of a dosage error.
Confidence in the vaccine took a further blow this month, when more than a dozen countries, mainly in Europe, temporarily suspended administration of the vaccine after reports linked it to a rare blood clotting disorder in a very small number of people.
The European Union’s drug regulator said last week that the vaccine was clearly safe, but an opinion poll conducted on Monday showed Europeans remained skeptical about its safety.
The AstraZeneca vaccine is considered crucial in addressing the spread of COVID-19 around the world because it is easier and cheaper to transport than rival vaccines.
It has been granted conditional marketing authorization or emergency use in more than 70 countries.
Many countries rely heavily on the vaccine to end the pandemic, and several state leaders have taken it publicly to boost confidence. – Kate Kelland and Julie Steenhuysen / Reuters
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