US Bets $0.5 Billion On Small, Untested Company to Deliver COVID Vaccinehttps://medicalxpress.com/news/2020-07-small-untested-company-covid-vaccine.htmlWhen 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 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.
... An estimated 700 million injections may be needed to inoculate the nation—at least two shots for every person, according to the 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.
... Despite the race to replenish the domestic needle and syringe supply, about 400 shipping containers of syringes have left the U.S. for countries including Germany, Colombia, Australia, Brazil and Italy this year, according to Panjiva Inc., a service that independently tracks global trade. That's the same, on average, as syringe exports over the past five years.
... Testing different vaccine candidates in the ApiJect devices will be critical before injecting 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 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."
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.When AP reached out directly to Trump's vaccine czar, Moncef Slaoui, to discuss the new 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.
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