ASSOCIATED PRESS
One patient received an injection on March 16 as a component of the first-stage clinical trial of the protection of a prospective vaccine opposed to COVID-19, the disease caused by the new coronavirus, at the Kaiser Permanente Washington Health Research Institute in Seattle.
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 vaccine strategy to get the vaccine out of the vaccine as temporarily as possible, Trump’s management agreed to invest more than a billion-dollar component in taxes at ApiJect Systems America, a new company. Its injector is approved by the federal fitness government and the company has still established a factory 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 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.
RELUCTANT SUPPLIER
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.” 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 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 with vaccines or curative products and be able to administer it.
According to Walker, the CEO, ApiJect is not interested in a federal contract: its goal was to replace the global future with fast and affordable injection devices that can 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.
Walker said he had told the admiral that the company was not planning to operate in the United States, but that he went through Giroir’s enthusiasm.
“He was the first, if not the only one in the event, who understood the revolutionary nature of this platform,” Walker recalled in an interview with AP. ‘And he said, ‘Wow, that’s unbelievable. You have to do it in the United States. »»
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 Projects Agency, a plan began to take shape for ApiJect to work 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 appliances would be manufactured in 3 to five years.
When the pandemic arose weeks later, the government sounded the alarm about a possible shortage of needles and syringes to administer a vaccine, whenever 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 trade adviser 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 the US inventory of needles and syringes … heading to other countries,” wrote Bright. “There is limited inventory in the supply chain, it could take 2+ years to make enough to satisfy the U.S. vaccine needs.”
Navarro said the United States would want 850 million needles.
“We would possibly be in a scenario where we have enough vaccines but there is no way to deliver everything,” he told the White House Working Group on Coronavirus in a February memorandum.
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.
Deformation speed operation
On a hot mid-May day in 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 was developed.
“We won’t have to be disadvantaged by our ability to deliver emergency drugs to Americans who need it,” HHS Secretary Alex Azar said.
According to the army document, it may take about 700 million injections to vaccinate the country, at least two injections per person.
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, it announced its goal for ApiJect to manufacture more than 500 million all-in-one devices that would be preloaded with the vaccine.
On Wednesday, the country’s largest needle and syringe manufacturer, Becton Dickinson, announced the first U.S. order. For $11.7 million for 50 million needles and syringes until the end of this year. It plans to increase production over the next year.
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 boxes of syringe shipments 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.
“There’s a lot of movement 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 are the focus, but they plan for the worst situation and hopes for the case,” Zehrung said.
WAITING FOR APPROVAL
ApiJect devices are self-contained, with flexible plastic bulbs that are pressed, such as a nasal spray or eye drops, to push the vaccine through a needle towards the patient.
The device includes a small PC chip, such as credit card chip, which can transmit data about the drug, dose, location and timing of administration. The chip is injected into patients.
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 plants to manufacture its 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 can interact with the liquid from the glass bottles recently used in the tests, experts say. And there are strict temperature requirements. The procedure planned through ApiJect is to pour the doses of the vaccine into the hot plastic ampoules as they leave the production line, the company said. ApiJect says they can immediately cool devices as they are manufactured.
Walker, the ApiJect CEO, who founded the online travel agency Priceline, acknowledges that the government’s decision to rely on “an emergency plan of refitting established pharmaceutical manufacturing facilities is risky. But we feel good about it.”
NO COMMENT
The Associated Press asked the Health and Human Services department 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 executive, who spoke on condition of 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.
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