As TrialSite has chronicled, AstraZeneca has struggled during the pandemic to keep open, transparent communications as an expectation. In “On Again Off Again: the Rollercoaster Associated with AstraZeneca,” the at times opaque and elusive elements associated with AZD1222 vaccine trial compound to what many consider an impact to the overall brand. Now it turns out, there is more to the story. AstraZeneca may have released outdated information on its latest COVID-19 vaccine trial, giving an “incomplete” picture of its efficacy, a leading U.S. health agency said on Tuesday, casting even more doubt on the shot’s potential U.S. rollout and plunging its developers, once again, into controversy. This is truly unfortunate. This vaccine shows enormous potential as it can be delivered around the world at compelling price points. Put another way, the world truly needs a vaccine such as this one, and the hope is that concepts such as transparency and accountability are embraced, even when circumstances are tough.
The surprise public rebuke from federal health officials comes just one day after interim data from the drugmaker showed better-than-expected results from the U.S. trial. That had been seen as a scientific counter to concerns that have dogged the shot over its effectiveness and possible side effects as TrialSite has chronicled in Europe. Just recently in Norway and Germany, researchers have possibly identified a link between the vaccine and occurrence of a severe adverse event centering on blood clotting. Now Reuters reports that the most recent trial data was in fact outdated. How could this happen?
The vaccine, developed with Oxford University, was 79% effective in preventing symptomatic illness in the large trial that also took place in Chile and Peru, according to the data. It was also 100% effective against severe or critical forms of the disease and hospitalisation, and posed no increased risk of blood clots.
DSMB and NIAID Statements
The Data Safety Monitoring Board (DSMB), an independent committee overseeing the trial, has “expressed concern that AstraZeneca may have included outdated information from that trial, which may have provided an incomplete view of the efficacy data,” the U.S. National Institute of Allergy and Infectious Diseases (NIAID) said in a statement released after midnight in the United States.
“We urge the company to work with the DSMB to review the efficacy data and ensure the most accurate, up-to-date efficacy data be made public as quickly as possible,” it said, adding that the DSMB had informed AstraZeneca of its concerns.
The statement raises fresh questions about the vaccine’s efficacy as it is being administered in dozens of countries worldwide and clouds the timeline for its emergency use authorization in the United States.
“DSMB externalisations of concerns are deeply unusual for multinational pharma companies and suggest an extraordinary high level of friction between the DSMB and the sponsor,” Citi analysts said in a note.
Reuters reports that the AstraZeneca shot has faced questions since late last year when the drugmaker and Oxford University published data with different efficacy readings due to a measurement error. TrialSite chronicled anomalies and some safety incidents that actually delayed the Phase 3 trial by several weeks in the United States.
Later analysis suggested the dosing interval rather than the amount of dose administered was responsible for the difference.
Most recently, as mentioned previously, more troubling signs associated with the vaccine in Europe unfolded as a number of serious adverse events were reported including some deaths. Hence, confidence in the vaccine took a further hit when several nations in Europe temporarily suspended the shot 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 it was safe but an opinion poll on Monday showed Europeans remained sceptical about its safety.
Anthony Fauci, who also serves as chief medical advisor to U.S. President Joe Biden, said on Monday the U.S. trial found no indication at all of the rare blood clots and the statement from the NIAID didn’t raise questions about the trial’s findings regarding blood clotting. So at least this concern doesn’t seem to be a factor in America.
The latest data, which has yet to be reviewed by independent researchers, was based on 141 infections among 32,449 participants.
The AstraZeneca vaccine is seen as crucial in tackling the spread of COVID-19 across the globe because it is easier and cheaper to transport than rival shots.
It has been granted conditional marketing or emergency use authorization in more than 70 countries. Many countries are relying heavily on it to end the pandemic, and several state leaders have taken the shot to boost confidence in the vaccine, including South Korea’s President Moon Jae-in who received it on Tuesday.
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