US bets on untested company to deliver Covid-19 vaccine

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. Its injector is not approved by federal health authorities and the company 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.

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“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 it's 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 US government.

ApiJect received a no-bid contract earlier this year from the Defence Department under an exception for “unusual and compelling urgency”.

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Authorities said the US 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.

ApiJect first appeared on the US government's radar almost two years ago when the company piqued the interest of Admiral Brett P Giroir, HHS's assistant secretary for health, at the World Health Organization's Global Conference on Primary Health Care in Astana, Kazakhstan.

Koska said Giroir was “blown away” by their technology and told them that if a pandemic hit, the strategic national stockpile was going to need a very fast way to get injections filled with vaccines or therapeutics and ready to deliver.

According to Walker, the CEO, ApiJect wasn't interested in a federal contract — they were aiming to change the developing world with quick, inexpensive injection devices that could save millions of lives.

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But at the conference, Walker found himself at a table with Giroir at a luncheon, just two seats apart. The admiral was fascinated by the low-cost injection technology, Walker said, and when Walker showed him the prototype that he always carries in his pocket, Giroir asked how they plan to do this in the US.

Walker said he told the admiral that the company wasn't planning to operate in the US but was struck by Giroir's enthusiasm.

“He was the first person, if not the only person at the event, who understood the revolutionary nature of this platform,” Walker recalled in an interview with AP.

“And he said, 'Wow this is amazing. You need to do this in the US."

"Walker continued to resist, he said, but Giroir — who is also a doctor specializing in pediatric critical care — “wasn't big on taking no for an answer,” Walker said.

At Giroir's urging they presented the prototype injector to US officials. HHS declined to make agency officials available for interviews. It wasn't until later when Walker was introduced by a friend to Col. Matthew Hepburn at the Defense Advanced Research Projects Agency, that a plan for ApiJect to work in the United States began to take shape, he said.

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.

When the pandemic emerged weeks later, officials sounded the alarm about a potential shortage of needles and syringes to deliver a vaccine if and when one became available. The federal Strategic National Stockpile of medical supplies had only 15 million syringes, according to Rick Bright, who later left his position at Health and Human Services and filed a whistleblower complaint.

Bright warned White House trade adviser Peter Navarro and his HHS colleagues of a looming needle shortfall, according to a series of emails disclosed in his complaint.