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When the valuable COVID-19 vaccine tanks are still ready, putting the important solution in the arms of Americans will require a lot of millions of injections.
As a component of its strategy to administer the vaccine as temporally as possible, Trump’s management agreed to invest more than $1 billion in taxes at ApiJect Systems America, a company whose injector is approved by the federal physical fitness government and has not yet established a plant to manufacture the devices.
The commitment to ApiJect eclipses government needle orders with a major manufacturer and two small businesses.
“The fact is, it would be crazy if other people just trusted us. I’d be the first to say it,” said Jay Walker, CEO of ApiJect. “We’re safeguarding America right now, but it’s probably not the main one.”
Trump’s management officials wouldn’t say why they’re investing so much in ApiJect technology. The company has manufactured only about 1,000 prototypes to date, and it is unclear whether those devices can supply vaccines recently in development. So far, leading applicants have used classic vials to involve the vaccine, as well as needles and syringes in their clinical trials.
ApiJect founder Marc Koska never intended to vaccinate the United States. For the past five years, he has been running his lifelong project to create a very cheap pre-filled syringe that he would like to reuse needles in the next countries.
Instead, the company’s largest visitor is 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.” 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 has promised ApiJect $138 million to produce $100 million from its appliance until the end of the year, requiring the company to upgrade new production lines at existing plants. And another $456 million is being introduced as a component of a public-private participation contract to bring online several new plants to manufacture 500 million additional devices to “contain the spread of the pandemic to minimize loss of life and have an effect in the U.S. economy, ” said the document.
These amounts are more than double the syringe charge that the government will pay other corporations for the job.
ApiJect made the first impression on the U.S. government’s radar. Just two years ago when the company attracted the interest of Admiral Brett P. Giroir, HHS Undersecretary of Health, at the World Health Organization’s World Primary Health Care Conference in Astana, Kazakhstan.
Koska said Giroir had been “impressed” through his generation and told them that if a pandemic was produced, strategic national inventory would want a very quick way to inject vaccines or curative products and be able to be administered.
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.
Pero en la conferencia, Walker se descubrió en una mesa con Giroir en un almuerzo, a solo dos asientos de distancia. The admiral fascinated with cheap injection technology, Walker said, and when Walker showed him the prototype he still carries in his pocket, Giroir asked how they planned to do it in the United States.
WARNING: Why is the COVID-19 vaccine race complicated?
Walker continued to resist, he said, but Giroir, who is also a pediatric intensive care physician, “wasn’t very susceptible to settle for a negative response,” Walker said.
At Giroir’s request, they presented the prototype injector to the U.S. authorities. HHS refused to have agency officials hired for interviews.
Only later, when Walker brought a friend to Colonel Matthew Hepburn of the Defense Advanced Research Project Agency, did he begin to form a plan for ApiJect for paintings in the United States, he said.
HHS Undersecretary of Preparation and Response Robert Kadlec approved a $10 million contract for ApiJect for studies and progression in January 2020, according to a federal procurement knowledge formula document. The company is guilty of securing personal investment to create new production lines where the devices would be manufactured in 3 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 Medical Materials Reserve contained only 15 million syringes, according to Rick Bright, who then left his social and social status and filed a whistleblower complaint.
Bright warned White House industry adviser Peter Navarro and his HHS colleagues of a close shortage of needles, according to a series of emails leaked in their complaint.
“We hear rumors about American stock of needles and syringes … moving to other countries,” Bright wrote. “There is a limited stock in the source chain, it can take more than 2 years to manufacture enough to satisfy the U.S. vaccine’s wishes.”
Navarro said the United States would want 850 million needles.
“We may find ourselves in a situation where we have enough vaccine but no way to deliver all of it,” he said in a February memo to the White House coronavirus task force.
He said the working organization “asks HHS BARDA to publish a program to identify all strategies for choosing vaccine delivery and increasing production.” BARDA is the authority for complex biomedical studies and progression within HHS.
Suddenly, ApiJect’s five-year plan to mass-produce its aircraft in a month with a new $138 million contract, announced in May, to produce one hundred million aircraft through the end of the year.
Jefferies Financial Group is the leader in the public-private partnership with HHS and invested $10 million to help ApiJect build production services in March. The company said it would pay to raise up to $1 billion more. There were no more investment ads.
Walker said that due to confidentiality agreements with the government and investors, the company cannot tell what funding it has received so far.
On a hot mid-May day at the White House Rose Garden, President Donald Trump introduced “a scientific, commercial and logistics company” called Operation Warp Speed.
The idea, he said, of being able to distribute a COVID-19 vaccine as soon as it developed.
In early May, they placed two orders, at Retractable Technologies in Little Elm, Texas, and Marathon Medical in Aurora, Colorado, for a total of 320 million needles and syringes.
Later, in May, he announced his goal for ApiJect to manufacture more than 500 million all-in-one devices that would be preloaded 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.
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And earlier this month, Retractable signed a contract for the time being with the government, the $53 million contract to spice up domestic manufacturing.
Together, this looks like injection devices.
But Retractable, which was involved sufficiently in its long monetary term to have won a $1.36 million loan from the PayCheck Protection Program earlier this year, made about 80% of its production in China. And Marathon is a medical supply distributor, and there is no indication on its online page that it manufactures needles and syringes. The company did not respond to repeated requests for comment.
Despite the race to fill the national with needles and syringes, around 400 syringe shipping boxes have left the United States to countries such as Germany, Colombia, Australia, Brazil and Italy this year, according to Panjiva Inc., a service that independently tracks global commerce. Matrix On average, this is the same as syringe exports in the last five years.
Experts agree that mass vaccination will be complicated.
“Many are moving to this,” said Dr. Bruce Gellin, president of global immunization at the Sabin Vaccine Institute.
Darin Zehrung, who studied medical devices at PATH, a nonprofit organization that advocates fitness equity, said it’s sensible to invest in new injection technologies. But it only works if there are many key syringes and needles in stock.
“Hedging bets is the best approach, but plan for the worst case scenario and hope for the best case scenario,” said Zehrung.
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 device includes a little computer chip — like the ones in credit cards — that can transmit information about the drug, dose, location and time of administration.
Other injection devices designed through Koska have been used in nearby countries, but this ApiJect technology.
The company said it has begun talks with the U.S. Food and Drug Administration. To prioritize the device, while the company is moving forward to meet with the plants to manufacture their injectors. The company did verify this, presenting its policy that prohibits the discussion of products involved in clinical trials.
The test of other candidate vaccines on ApiJect devices will be performed before injecting to the public.
Plastic could interact differently with the liquid than the glass vials currently used in trials, experts say. And there are strict temperature requirements. ApiJect’s planned process is to pour vaccine doses into the warm plastic blisters as they come off the production line, the company says. ApiJect says they can instantly cool the devices as they are made.
Walker, the CEO of ApiJect, which founded the online firm Priceline, acknowledges that the government’s resolve to rely on “an emergency plan to rebuild established pharmaceutical production services is risky.” But we feel good.
The Associated Press requested the government’s approach to the Department of Health and Human Services for several weeks. The firm did not allow an official to speak publicly about the story.
A senior management officer, who spoke under anonymity because the company refused to allow him to identify himself by name, told AP that he did not know ApiJect or the contract. But he said the government buys a variety of devices to manage the vaccine because they didn’t know what they needed. And, he said, the Trump administration is trying to bring domestic manufacturing to life.
When the AP contacted Trump’s vaccine tsar, Moncef Slaoui, directly to discuss the new technology, a spokesman said the application was inappropriate.
“If this continues, we probably wouldn’t do anyone else either,” Natalie Baldassarre, HHS’s special assistant, wrote in an email.
Last week, HHS Undersecretary for Public Affairs Michael Caputo wrote that the company had “lost interest in its history” and did not comment further.
This story is a component of ongoing research through the Associated Press, the PBS FRONTLINE series and the Global Reporting Center that examines the fatal consequences of the fragmented global medical chain.
Mendoza reported from San Francisco. Linderman reported from Baltimore. Lauran Neergaard and Stephen Braun in Washington contributed.
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