As vaccine approvals loom, U.S. funds a backup plan for delivery

As the United States makes plans for an extensive COVID-19 vaccination effort, the Trump administration extended a $590 million loan to ApiJect Systems America, a maker of a novel injection device that still awaits FDA approval. The loan is in addition to roughly $150 million in previous contracts ApiJect made with both HHS and the Defense Department for the company’s single-dose plastic injection “syrette,” which is slightly larger than a person’s thumb. The U.S. International Development Finance Corp. (DFC) was expected to announce the loan on November 19. The single-use, self-contained devices are intended to serve as an alternative to existing vials and syringes. Nicole Lurie, a strategic adviser at the Coalition for Epidemic Preparedness Innovations, says: “I think it is sensible to have backups to glass vials.” However, she is concerned the administration is investing in a technology that has not yet cleared FDA hurdles. Regarding the syringes, she says: “They probably need to be tested for each vaccine and especially each vaccine platform.” The DFC financing is meant to help ApiJect construct a 1 million-square-foot campus in North Carolina to make the devices from pharmaceutical-grade plastic resin. ApiJect anticipates that when its new “GigaFactory” is fully operational, it will manufacture as many as 3 billion single-dose injectors annually.