By Julie Steenhuysen
CHICAGO (Reuters) – AstraZeneca Plc is preparing to apply for US emergency use authorization (USA) for its COVID-19 vaccine at the end of this month or early April, after accumulating enough data to judge the effectiveness of inoculation, sources with knowledge of the Reuters clinical trial underway on Friday said.
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 familiar with the trial told Reuters.
The number of COVID-19 cases among those who received the vaccine versus infections in participants who received a placebo will show how effective the injection of AstraZeneca was in preventing disease in people aged 18 and over.
The AstraZeneca vaccine, developed in collaboration with the University of Oxford, has been authorized for use in the European Union and in many countries, but not yet by US regulators.
“The results of the US Phase III study are necessary for the FDA’s assessment of a US order for our vaccine,” said a company spokesman, without confirming the trial details reported by Reuters. “We hope that data from our US Phase III study will be available soon, in the coming weeks, and we plan to apply for emergency use authorization shortly thereafter.”
The highly anticipated test results in the United States can help address safety concerns stemming from reports of severe blood clots in some vaccine recipients that have prompted several countries to discontinue vaccine administration.
An advisory committee of experts from the World Health Organization is examining the matter.
The data can also help determine what happens to doses that are already in deposits in the U.S. pending approval. The New York Times reported on Thursday that some countries have asked to purchase doses of the vaccine that are not currently offered in the United States.
AstraZeneca said in February that it expects its vaccine to receive US emergency use authorization in early April and to be able to immediately deliver 30 million doses to locations in the United States.
At a press conference on Friday, White House coronavirus response coordinator Jeff Zients said the United States has a small stock of AstraZeneca vaccine, which it plans to maintain and distribute to Americans should a US be granted.
The US stance may frustrate AstraZeneca’s efforts to come closer to meeting its contractual obligation with the EU of 180 million doses in the second quarter.
AstraZeneca told the EU earlier this year that 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 further reduction 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; Editing by Peter Henderson and Bill Berkrot)