Wednesday, November 25, 2020

U.S. to test run Covid vaccine distribution networks as it awaits FDA clearance in ‘just a few weeks’


Noah Higgins-Dunn

The U.S. federal government is conducting a practice run this week of its coronavirus vaccine distribution networks with some test shipments as the drugs await emergency approval from the Food and Drug Administration in “just a few weeks.”

The dry run is part of a series of field exercises under the Trump administration’s vaccine program Operation Warp Speed, Health and Human Services Secretary Alex Azar told reporters during a press briefing Tuesday. The shipments, which won’t contain the actual vaccine vials, will test the systems used by state health departments to order vaccine doses to “ensure that all goes smoothly,” Azar said.

Pfizer, which is developing its vaccine with BioNTech, applied for emergency use authorization from the FDA on Friday. The agency is expected to review Pfizer’s vaccine when its Vaccines and Related Biological Products Advisory Committee next meets on Dec. 10. Moderna is expected to submit its application in the coming days so both vaccines could potentially get reviewed at the same time.

“If all goes well, we could be distributing vaccine soon after Dec. 10,” Azar said. “We believe we can distribute vaccine to all 64 jurisdictions within 24 hours of FDA authorization. Then we hope administration can begin as soon as the product arrives.”  Read more >>