The agencies set up a phased OTA contract to test manufacturing capabilities at scale to ensure the industry is ready to meet demand as new treatments are approved.
As the COVID-19 pandemic rages on, the only path to a healthy nation will be development and wide distribution of a vaccine to prevent spreading and treatments to heal those already infected. For the latter effort to be effective, successful treatments need to be manufactured at a large scale, and the federal government wants to help.
The departments of Defense and Health and Human Services—using an other transaction authority contract through Army Contracting Command—want to ensure therapeutic COVID-19 treatments can move from prototype to large-scale manufacturing and are developing a program to demonstrate such capabilities.
“It is critical for the sponsors of COVID-19 therapeutic candidates to initiate at-scale prototype manufacturing to demonstrate the target population capability,” according to a request for project proposals released Friday. “As such, the USG will support at-scale manufacturing—through packaging and release testing—of selected [medical countermeasures], to ensure timely availability to the U.S. population when needed.”
If the prototype phases are successful, the government has the option to award a no-bid production contract. If that occurs, officials expect deliverables on the scale of “800,000 treatments per quarter for up to 18 months,” according to the RPP. The first batch—100,000 treatments for a selected population—must be ready for distribution by December 31.
While those deliverables are upper limits, the RPP does not mandate specific minimum production quantities. That said, “the intent is ‘large scale production capability in a short period of time with little to no advance notice,’” the document states, and proposers should be able to show an ability to ramp up production as needed.
To be eligible, a treatment must show, at a minimum, that it can obtain an Emergency Use Authorization from the FDA “and/or a reasonable chance of moving to Phase III clinical trials” by the end of 2020. Proposers must also have started Phase I clinical studies “no later than August 31, 2020.”
The call for proposals is open through February 28, 2021. Questions are due no later than February 26.
While the request for project proposals does not guarantee a future solicitation, the lead agencies are “highly confident funds will be available,” according to the RPP.