The federal government has awarded a $590 million loan to ApiJect Systems America for a novel injection device the company said could be used instead of traditional glass vials and syringes for vaccinations.
The device, which hasn't received FDA approval to be used for vaccines, is a single-use device designed as an alternative to traditional vials and syringes. Public health officials have expressed concern that a shortage of glass vials could cause delays in distributing a COVID-19 vaccine.
ApiJect, based in Stamford, Conn., said it can mass-produce the device to deliver vaccines around the world and make up to 3 billion injectors in a year.
"I think it is sensible to have backups to glass vials. The challenge that I see is that it is a completely untested technology, and it is not clear to me what kinds of conversations ApiJect has had with the FDA or any other regulators," Nicole Lurie, MD, a strategic adviser at the Coalition for Epidemic Preparedness Innovations, told NPR. "What testing has been done to ensure that the materials inside the containers don't interact with the compounds of various vaccines? They probably need to be tested for each vaccine and especially each vaccine platform."
ApiJect has said its device can handle the ultra-low temperature Pfizer's COVID-19 vaccine requires, but the FDA hasn't authorized it to do so, NPR reported.