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The British drugmaker completed enrollment in its trial of more than 32,000 volunteers in January and now has data on at least 150 cases of COVID-19, two sources knowledgeable about the trial told Reuters.
The amount of COVID-19 cases among those who got the vaccine versus infections in participants who received a placebo will show how effective the AstraZeneca shot was at preventing disease in those age 18 and over.
The AstraZeneca vaccine, developed in collaboration with Oxford University, has been approved to be used in theEuropean Union and many countries but not yet by U.S. regulators.
“The U.S. Phase III study results are essential for the FDA’s evaluation of an EUA request for our vaccine,” a company spokeswoman said, without confirming trial details being reported by Reuters. “We expect data from our U.S. Phase III trial to be available soon, in the coming weeks, and we intend to apply for emergency use authorization shortly thereafter.”
Highly anticipated results from the U.S. trial could help settle safety concerns arising over reports of serious blood clots in certain vaccine recipients who have led several states to pause administering the vaccine.
A World Health Organization expert advisory committee islooking into the matter.
The data could also help determine what becomes of doses already sitting in U.S. warehouses awaiting approval. The New York Times reported Thursday that some nations have been requesting to secure doses of this vaccine not currently being offered in america.
AstraZeneca said in February it expects its vaccine could receive U.S. emergency use authorization at the beginning of April and could instantly deliver 30 million doses to places around the United States.
In a Friday press briefing, White House Coronavirus Response Coordinator Jeff Zients said the United States has a small inventory of the AstraZeneca vaccine, which it intends to keep and deploy to Americans should an EUA be granted.
The U.S. stance could thwart AstraZeneca’s efforts to come closer to delivering on its contractual obligation with the EU of 180 million doses in the second quarter.
AstraZeneca told the EU earlier this year it would cut its supplies in the second quarter by at least half to less than 90 million doses, EU sources told Reuters, after a larger reduction in the first few months of the year.
