AstraZeneca Seeks FDA Coronavirus Authorization Based on Foreign Trial Data
AstraZeneca said Monday that it will submit preliminary data from from large clinical trials in the U.K. and Brazil to the FDA as part of an application for emergency authorization.
Data from those trials show the vaccine was about 70 percent effective across two different dosing regimens. When the vaccine was given as a half dose and then a full dose one month later to about 2,700 participants, it had an efficacy of 90 percent. When given as two full doses at least one month apart to about 8,900 participants, it showed 62 percent efficacy.
AstraZeneca is the third Covid-19 vaccine maker to report results from a late-stage trial. A company spokesperson said it “will begin the submission of the clinical data to regulators around the world that have a framework in place for emergency use or conditional approval. This includes the FDA.”
