US bets on young company to deliver vaccine
Injection devices not approved by authorities; factory space not set up
When precious vats of COVID-19 vaccine are finally ready, jabbing the lifesaving solution into the arms of Americans will require hundreds of millions of injections.
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 whose injector is not approved by federal health authorities and that hasn’t yet set up a factory to manufacture the devices.
The commitment to ApiJect dwarfs the other needle orders the government has placed with a major manufacturer and two other small companies.
“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.
ApiJect founder Marc Koska never intended to vaccinate the United States. For the past five years, he’s been working on his lifetime mission of creating an ultra-low-cost prefilled syringe that would reduce the need to reuse needles in the developing world.
Instead, the company’s biggest customer has become the U.S. government.
ApiJect received a no-bid contract earlier this year from the Defense Department under an exception for “unusual and compelling urgency.”
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 an additional $456 million as part of a public-private partnership contract to bring online several new factories to make 500 million more devices to “contain the pandemic spread to minimize the loss of life and impact to the United States economy,” a military document says.
These amounts are more than double the per-syringe cost the government is paying other companies for the work.
In early May, the government put in two orders, to Retractable Technologies in Little Elm, Texas, and Marathon Medical in Aurora, Colorado, totaling 320 million needles and syringes.
Later in May, the government announced plans for ApiJect to manufacture more than 500 million all-in-one devices that would come pre-loaded with the vaccine.
On Wednesday, the largest domestic manufacturer of needles and syringes, Becton Dickinson, announced the first U.S. order of $11.7 million for 50 million needles and syringes by the end of this year. It plans to ramp up manufacturing over the next year.
And earlier this month Retractable entered into a second contract with the government, this one for $53 million to boost domestic manufacturing.
Together that sounds like enough injection devices.
But Retractable, which was worried enough about its financial future that earlier this year it received a $1.36 million loan from the Paycheck Protection Program, has been doing about 80% of its manufacturing in China. And Marathon is a medical supply distributor, and there is no indication on its website that it manufactures needles and syringes at all. The company did not respond to repeated requests for comment.
Experts acknowledge that a mass vaccination campaign is going to be complicated.
“There are a lot of moving parts to this,” said Dr. Bruce Gellin, the Sabin Vaccine Institute’s president of global immunization.
Darin Zehrung, who studied medical devices at PATH, a nonprofit advocating for health equity, said it’s wise to invest in new injection technologies. But that only works if there are plenty of basic syringes and needles stocked up.
“Hedging bets is the best approach, but plan for the worst-case scenario and hope for the best-case scenario,” said Zehrung.
The Associated Press asked the U.S. Department of Health and Human Services over many weeks to explain the government’s approach. The agency didn’t allow an official to speak on the record for this story.
A senior administration official, speaking on condition of anonymity because the agency declined to allow him to identified by name, told AP he wasn’t familiar with ApiJect or the contract. But he said the government was buying a range of devices to deliver the vaccine because it doesn’t know what it needs.
When AP reached out directly to Trump’s vaccine czar, Moncef Slaoui, to discuss the technology, a spokesperson said the query was inappropriate.
“If this continues, we will make no one else available either,” Natalie Baldassarre, a special assistant at HHS, wrote in an email.
Last week, HHS Assistant Secretary of Public Affairs Michael Caputo wrote that the agency has “lost interest in assisting your story” and offered no further comment.