US bets on small, untested company to deliver COVID vaccine

When precious vats of COVID-19 vaccine are finally rey, jabbing lifesaving solution into arms of Americans will require hundreds of millions of injections.

As part of its strategy to minister vaccine as quickly as possible, Trump ministration has agreed to invest more than half a billion in tax dollars in ApiJect Systems America, a young company whose injector is t approved by federal health authorities and that hasn’t yet set up a factory to manufacture devices.

commitment to ApiJect dwarfs or needle orders government has placed with a major manufacturer and two or small companies.

“ fact of this matter is, it would be crazy for people to just rely on us. I would be first to say it,” said ApiJect CEO Jay Walker. “We should be America’s backup at this point, but probably t its primary.”

Trump ministration officials would t say why y are investing so heavily in ApiJect’s techlogy. company has me only about 1,000 protos to date, and it’s t clear wher those devices can deliver vaccines that are currently in development. So far, leing candidates are using tritional vials to hold vaccine, and needles and syringes in ir clinical trials.

RELUCTANT SUPPLIER

ApiJect founder Marc Koska never intended to vaccinate United States. For past five years, he’s been working on his lifetime mission of creating an ultra low-cost prefilled syringe that would reduce need to reuse needles in developing world.

Inste, company’s biggest customer has become U.S. government.

ApiJect received a -bid contract earlier this year from Defense Department under an exception for “unusual and compelling urgency.” Authorities said U.S. Department of Health and Human Services, tasked with buying necessary supplies, “does t have resources or capacity to conduct procurements necessary to respond to COVID-19 pandemic,” according to a June 5 military document.

government promised ApiJect $138 million to produce 100 million of its devices by end of year, which will require company to retrofit new manufacturing lines in existing factories. And it’s offered ar $456 million as part of a public-private partnership contract to bring online several new factories to make ar 500 million devices to “contain pandemic spre to minimize loss of life and impact to United States ecomy,” said document.

se amounts are more than double per-syringe cost government is paying or companies for work.

ApiJect first appeared on U.S. government’s rar almost two years ago when company piqued interest of miral Brett P. Giroir, HHS’s assistant secretary for health, at World Health Organization’s Global Conference on Primary Health Care in Astana, Kazakhstan.

Koska said Giroir was “blown away” by ir techlogy and told m that if a pandemic hit, strategic national stockpile was going to need a very fast way to get injections filled with vaccines or rapeutics and rey to deliver.

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

But at conference, Walker found himself at a table with Giroir at a luncheon, just two seats apart. miral was fascinated by low-cost injection techlogy, Walker said, and when Walker showed him proto that he always carries in his pocket, Giroir asked how y plan to do this in U.S.

Walker said he told miral that company wasn’t planning to operate in U.S. but was struck by Giroir’s enthusiasm.

“He was first person, if t only person at event, who understood 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 U.S.’”

Walker continued to resist, he said, but Giroir — who is also a doctor specializing in pediatric critical care — “wasn’t big on taking for an answer,” Walker said.

At Giroir’s urging y presented proto injector to U.S. officials. HHS declined to make ncy officials available for interviews.

It wasn’t until later, when Walker was introduced by a friend to Col. Matw Hepburn at Defense vanced Research Projects ncy, that a plan for ApiJect to work in United States began to take shape, he said.

HHS Assistant Secretary for Preparedness and Response Robert Klec approved a $10 million contract for ApiJect for research and development in January 2020, according to a document in federal procurement data system. company was responsible for securing private investments to create new production lines where devices would be me over three to five years.

When pandemic emerged weeks later, officials sounded alarm about a potential short of needles and syringes to deliver a vaccine if and when one became available.

federal Strategic National Stockpile of medical supplies h only 15 million syringes, according to Dr. Rick Bright, who later left his position at Health and Human Services and filed a whistleblower complaint.

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

“We are hearing rumblings about US inventory of needles and syringes … heing to or countries,” wrote Bright. “re is limited inventory in supply chain, it could take 2+ years to make eugh to satisfy U.S. vaccine needs.”

Navarro said U.S. would need 850 million needles.

“We may find ourselves in a situation where we have eugh vaccine but way to deliver all of it,” he said in a February memo to White House coronavirus task force.

He recommended task force “direct HHS BARDA to initiate a program to identify all alternate vaccine delivery methods and ramp up production.“ BARDA is Biomedical vanced Research and Development Authority within HHS.

Suddenly ApiJect’s 5-year plan to mass produce its devices became a sprint measured in months with a new $138 million contract, anunced in May, to produce 100 million devices by year’s end.

Jefferies Financial Group is acting as leer of public-private partnership with HHS and invested $10 million to help ApiJect build surge production facilities in March. company said it would try to raise up to $1 billion more. re have been ditional anuncements of funding.

Walker said due to ndisclosure agreements with both government and investors, company is unable to say what private funding y’ve secured so far.

OPERATION WARP SPEED

On a warm mid-May day in White House Rose Garden, President Donald Trump introduced “a massive scientific, industrial and logistical endeavor” dubbed Operation Warp Speed.

idea, he said, was to be rey to distribute a COVID-19 vaccine as soon as it was developed.

“We must t be caught short on our capacity to deliver emergency drugs to Americans in need,” said HHS Secretary Alex Azar.

An estimated 700 million injections may be needed to iculate nation -- at least two shots for every person, according to military document.

In early May, government put in two orders, to Retractable Techlogies in Little Elm, Texas, and Marathon Medical in Aurora, Coloro, totaling 320 million needles and syringes.

Later in May, government anunced plans for ApiJect to manufacture more than 500 million all-in-one devices that would come pre-loed with vaccine.

On Wednesday, largest domestic manufacturer of needles and syringes, Becton Dickinson, anunced first U.S. order of $11.7 million for 50 million needles and syringes by end of this year. It plans to ramp up manufacturing over next year.

And earlier this month Retractable entered into a second contract with government, this one for $53 million meant to boost domestic manufacturing.

Toger that sounds like eugh injection devices.

But Retractable, which was worried eugh about its financial future that earlier this year it received a $1.36 million loan from Paycheck Protection Program, has been doing about 80% of its manufacturing in China. And Marathon is a medical supply distributor, and re is indication on its web site that it manufactures needles and syringes at all. company did t respond to repeated requests for comment.

Despite race to replenish domestic needle and syringe supply, about 400 shipping containers of syringes have left U.S. for countries including Germany, Colombia, Australia, Brazil and Italy this year, according to Panjiva Inc., a service that independently tracks global tre. That’s same, on aver, as syringe exports over past five years.

Experts ackwledge that a mass vaccination campaign is going to be complicated.

“re are a lot of moving parts to this,” said Dr. Bruce Gellin, Sabin Vaccine Institute’s president of global immunization.

Darin Zehrung, who studied medical devices at PATH, a nprofit vocating for health equity, said it’s wise to invest in new injection techlogies. But that only works if re are plenty of basic syringes and needles stocked up.

“Hedging bets is best approach, but plan for worst case scenario and hope for best case scenario,” said Zehrung.

AWAITING APPROVAL

ApiJect’s devices are self-contained, with soft plastic blisters that are squeezed, like a se spray or eye drop, to push vaccine through an attached needle and into patient.

device includes a little computer chip — like ones in credit cards — that can transmit information about drug, dose, location and time of ministration.

Or injection devices Koska designed have been used in developing world, but this ApiJect techlogy has t.

company said y have started discussions with U.S. Food and Drug ministration to review device on a priority basis while company moves ahe fitting factories to make ir injectors. ncy wouldn’t confirm this, citing its policy against discussing products involved in clinical trials.

Testing different vaccine candidates in ApiJect devices will be critical before injecting public.

Plastic could interact differently with liquid than glass vials currently used in trials, experts say. And re are strict temperature requirements. ApiJect’s planned process is to pour vaccine doses into warm plastic blisters as y come off production line, company says. ApiJect says y can instantly cool devices as y are me.

Walker, ApiJect CEO, who founded online travel ncy Priceline, ackwledges that government’s decision to rely on “an emergency plan of refitting established pharmaceutical manufacturing facilities is risky. But we feel good about it.”

COMMENT

Associated Press asked Health and Human Services department over many weeks to explain government’s approach. ncy didn’t allow an official to speak on record for this story.

A senior ministration official, speaking on condition of anymity because ncy declined to allow him to identified by name, told AP he wasn’t familiar with ApiJect or contract. But he said government was buying a range of devices to deliver vaccine because y don’t kw what y need. And, he said, Trump ministration is looking to boost domestic manufacturing.

When AP reached out directly to Trump’s vaccine czar, Moncef Slaoui, to discuss new techlogy, a spokesperson said query was inappropriate.

“If this continues, we will make one else available eir,” Natalie Baldassarre, a special assistant at HHS, wrote in an email.

Last week, HHS Assistant Secretary of Public Affairs Michael Caputo wrote that ncy has “lost interest in assisting your story” and offered furr comment.