As part of its strategy to administer the vaccine as quickly as possible, the Trump administration has agreed to invest more than half a billion in tax dollars in ApiJect Systems America, a young company. However, its injector is not approved by federal health authorities and the company hasn’t yet set up a factory to manufacture the devices.
“The fact of this matter is, it would be crazy for people to just rely on us. I would be the first to say it,” said ApiJect CEO Jay Walker. “We should be America’s backup at this point, but probably not its primary.”
Trump administration officials would not say why they are investing so heavily in ApiJect’s technology. The company has made only about 1,000 prototypes to date, and it’s not clear whether those devices can deliver the vaccines that are currently in development. So far, the leading candidates are using traditional vials to hold the vaccine, and needles and syringes in their clinical trials.
Contracted With the DoD
ApiJect received a no-bid contract earlier this year from the Defense Department under an exception for “unusual and compelling urgency.” Authorities said the U.S. Department of Health and Human Services, tasked with buying the necessary supplies, “does not have the resources or capacity to conduct procurements necessary to respond to the COVID-19 pandemic,” according to a June 5 military document.
The government promised ApiJect $138 million to produce 100 million of its devices by the end of the year, which will require the company to retrofit new manufacturing lines in existing factories. And it’s offered another $456 million as part of a public-private partnership contract to bring online several new factories to make another 500 million devices to “contain the pandemic spread to minimize the loss of life and impact to the United States economy,” said the document.
These amounts are more than double the per-syringe cost the government is paying other companies for the work.
HHS Assistant Secretary for Preparedness and Response Robert Kadlec approved a $10 million contract for ApiJect for research and development in January 2020, according to a document in the federal procurement data system. The company was responsible for securing private investments to create new production lines where the devices would be made over three to five years.
Suddenly, ApiJect’s 5-year plan to mass produce its devices became a sprint measured in months with a new $138 million contract, announced in May, to produce 100 million devices by year’s end.
Approval Still Needed
ApiJect’s devices are self-contained, with soft plastic blisters that are squeezed, like a nose spray or eye drop, to push the vaccine through an attached needle and into the patient.
The company said they have started discussions with the U.S. Food and Drug Administration to review the device on a priority basis while the company moves ahead fitting factories to make their injectors. The agency wouldn’t confirm this, citing its policy against discussing products involved in clinical trials.
According to the company website, “In a national bio-emergency such as a pandemic, nations may require ‘surge capacity’ – the ability to package hundreds of millions of doses of drugs or vaccines on short notice. This task can be extremely difficult when relying on glass vials, due to the limited capacities of ‘just in time’ supply chains. BFS prefilled syringes are ideal for this challenge, as a single BFS manufacturing line can produce 15 million finished BFS prefilled syringes per month. That is why ApiJect has joined forces with the U.S. Government to create The RAPID Consortium, a public-private partnership that strengthens America’s surge capacity.”
The company was founded in 2016, and one of the founders is in fact an inventor of a form of flexible syringe. With what appears to be about 20 employees, it is not clear how such a new upstart could secure such a large contract. What else is going on here, we can’t be certain.
Call to Action: Will the U.S. be ready to administer a potential COVID-19 vaccine? It sure looks like they’re trying, but why such a heavy investment into an unapproved syringe technology? Sign up for our daily newsletter for updates on the situation.