AstraZeneca, whose Phase 3 coronavirus vaccine clinical trial has been on hold for more than a month, did not get critical safety data to the US Food and Drug Administration until last week, according to a source familiar with the trial
.
The FDA is considering whether to allow AstraZeneca to restart its trial after a participant became ill. At issue is whether the illness was a fluke, or if it may have been related to the vaccine. The source said the root of the delay is that the participant was in the United Kingdom, and the European Medicines Agency and the FDA store data differently.
The source who said the information was handed over to the FDA last week, agreed with Califf that the agency is going to be very methodical about reviewing the data. "I'm sure the FDA wants to make their decision as soon as they can, but they also need to make sure that decision is sound. It's critical to the American public. And it's critical that the American public has trust in the FDA. If we lose trust in the FDA, we're done," the source said.
United States Latest News, United States Headlines
Similar News:You can also read news stories similar to this one that we have collected from other news sources.
CNN Underscored | Product Reviews, Gift Ideas, Gadget Guides and MoreUnderscored is an online shopping guide for buying and reading reviews on the best tech, travel, health and lifestyle products from around the web
Read more »
Trump rally chants 'CNN sucks,' Jim Acosta says getting Covid 'also sucks'The network's White House correspondent reacted at the heckle at the non-socially distanced rally, at which President Donald Trump said he felt 'immune' to the coronavirus.
Read more »
What Happened Other Times a Vaccine Was Rushed?The delivery of a vaccine against COVID-19 promises to be an astonishing feat, with about 800 million doses of vaccine from six manufacturers funded through Operation Warp Speed. But what can we learn from past vaccines that have been rushed?
Read more »