By Julie Steenhuysen
CHICAGO (Reuters) – AstraZeneca Plc is preparing to apply to the US Emergency Response Center (EUA) for its COVID-19 vaccine later this month or in early April, after gathering enough data to assess the effectiveness of the vaccination. said sources with knowledge of the ongoing clinical trial. Reuters Friday.
The British drugmaker completed more than 32,000 volunteers’ trial run in January and now has information on at least 150 cases of COVID-19, two sources familiar with the trial told Reuters.
The number of COVID-19 cases among those who received the vaccine against infections in participants who received a placebo will show how effective the AstraZeneca shot was in preventing disease at the age of 18 years.
The AstraZeneca vaccine, developed in collaboration with the University of Oxford, has been approved for use in the European Union and many countries, but not yet by US regulators.
“The U.S. Phase III study results are needed for the FDA’s evaluation of an EUA request for our vaccine,” a company spokesman said without confirming that the trial details were reported by Reuters. “We expect data from our U.S. Phase III trial to be available soon, in the coming weeks, and we plan to file an emergency permit application shortly thereafter.”
Highly anticipated results of the US trial could help rule out safety concerns arising from reports of severe blood clots in some vaccine recipients, which led to the vaccine being discontinued.
An expert advisory committee of the World Health Organization is investigating the matter.
The data could also help determine what happens to doses already sitting in U.S. warehouses awaiting approval. The New York Times reported Thursday that some countries have asked to obtain doses of the vaccine that are not currently offered in the United States.
AstraZeneca said in February it expected the vaccine to be able to receive US emergency use in early April and deliver 30 million doses immediately in places in the United States.
In a Friday press briefing, White House coronavirus response coordinator Jeff Zients said Jeff Zients said the United States has a small inventory of the AstraZeneca vaccine, which he plans to keep and deploy to Americans if an EUA is granted.
The US stance could thwart AstraZeneca’s efforts to come closer to the EU’s 180 million dose contractual obligation in the second quarter.
AstraZeneca told the EU earlier this year that it would reduce its inventory by at least half to less than 90 million doses in the second quarter, EU sources told Reuters, after a larger decline in the first three months of the year .
(Reporting by Julie Steenhuysen; Additional reporting by Carl O’Donnell in New York and Jeff Mason in Wahsington; Edited by Peter Henderson and Bill Berkrot)