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AstraZeneca signals it won’t wait for US data to seek clearance of coronavirus vaccine

AstraZeneca biopharmaceuticals chief Mene Pangalos said Thursday that clinical trials already underway in the U.K., Brazil and South Africa should provide enough evidence to support regulatory authorization of its experimental coronavirus vaccine.
Results from those studies are expected later this year and could potentially come before data are disclosed from a planned 30,000-patient U.S. trial. The British drugmaker is expected to soon start that study, one of five being supported by a U.S. National Institutes of Health effort to quickly enroll 150,000 people into vaccine trials.
Pangalos’ comments, said to investors on a company earnings call, come days after Moderna and Pfizer/BioNTech began enrolling people into late-stage trials of their respective vaccines. AstraZeneca’s, which was invented and developed at the University of Oxford, is considered a leading effort among the global race to ready a vaccine for use as quickly as possible.
AstraZeneca quickly licensed what’s now known as AZD1222 soon after it emerged from laboratories at the University of Oxford earlier this year. The pharma has since secured funding and manufacturing capacity to produce more than 2 billion doses. Of that, the U.S. has signed up for 300 million and the U.K. 100 million, while another 1 billion have been earmarked for low- and middle-income countries.

AstraZeneca has emphasized the need for broad, global access to a vaccine, and CEO Pascal Soriot again confirmed the company’s intention not to make money on the product, at least during the pandemic. ”

There will be no profit from the vaccine this year,” he said Thursday.

AstraZeneca and the University of Oxford have been quicker than most of their rivals to start up multiple studies, even though they haven’t begun their largest test, a planned 30,000-volunteer U.S. trial. But company officials indicated on Thursday that the trials already underway would underpin a regulatory submission.

Those studies aim to enroll a total of 17,000 participants, with 10,000 coming from the Phase 2/3 COV002 study underway in the U.K. The Brazil and South Africa trials were initiated in order to move into coronavirus hotspots with a higher “attack rate,” or, rate of people at risk of contracting symptomatic disease, Soriot said.

While the big U.S. efficacy trials that began this week have set a goal of enrolling 30,000 patients each, that enrollment number is not necessarily the minimum bar to gain an emergency authorization or approval, according to Food and Drug Administration guideline. The document only states that trials need to enroll “many thousands” of people.

Pangalos said data across the three trials already underway can be pooled together for purposes of a regulatory submission because the main goal of the trials are “exactly the same” — prevention of symptomatic disease caused by a confirmed infection of the SARS-CoV-2 virus.

AstraZeneca expects data from all of its trials, including the pending U.S. study, by the end of the year. However, because the trials in the U.K., Brazil and South Africa are already recruiting patients while the U.S. one isn’t yet, they could generate results first.

A company spokesperson did not respond to questions from BioPharma Dive whether the three trials now recruiting would be part of an FDA submission, or if AstraZeneca would wait for data from the U.S. trial.