LONDON (AP) — AstraZeneca said Thursday that it intends to seek U.S. approval for its COVID-19 vaccine in the second half of this year, further delaying the long-awaited application.
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Hopeful signs today: Pfizer and BioNTech will seek emergency approval for coronavirus vaccines with an aim to deliver doses by the end of the year. Plus: Who will get the shots first? Get 26 of your vaccine and virus questions answered here.
It’s pretty easy when you have vaccines that are 95% effective. Can’t get much better than that. I think what people need to appreciate — and that’s why I have said it like maybe 100 times in the last week or two — is the process by which a decision is made. The company looks at the data. I look at the data. Then the company puts the data to the FDA. The FDA will make the decision to do an emergency use authorization or a license application approval. And they have career scientists who are really independent. They’re not beholden to anybody. Then there’s another independent group, the Vaccines and Related Biological Products Advisory Committee. The FDA commissioner has vowed publicly that he will go according to the opinion of the career scientists and the advisory board.
Drug giant AstraZeneca said Tuesday it had paused global trials of its coronavirus vaccine because of an unexplained illness in one of the volunteers.
The EUA program, established in 2004, gives the U.S. Food and Drug Administration the power to grant temporary, accelerated approval to a medical drug or device needed in a public health emergency. The EUA review process is less rigorous than a regular approval.
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