Nearly $1.3 Billion in OWS Funds Went to ApjJect Systems for Syringes Yet to Be Authorized

Syringe

Operation Warp Speed, the government response to the COVID-19 pandemic under former President Donald Trump, awarded tens of billions of dollars to multiple life sciences companies to combat the novel coronavirus. Much of the financing yielded positive results with vaccines and therapeutics. Some of the money has yet to generate any visible result.

In a new reportNBC focuses on one company that received nearly $1.3 billion in government loans and grants to manufacture essential syringes to support vaccine rollout. Connecticut-based ApiJect Systems Corp. was first awarded funding from the Department of Defense to develop pre-filled syringes for vaccine use. 

In November 2020, the company received a $590 million loan from the U.S. International Development Finance Corporation to support the construction of a new manufacturing facility that was expected to produce up to three billion single-dose prefilled injectors each year. However, as NBC reported, there has been little fruit yielded from these investments.

With approximately half the U.S. adult population now vaccinated or having received the first dose, questions are rising about the potential role ApiJect might play in the pandemic response. Its syringes have yet to go through regulatory testing required before they can be used, and the “Gigafactory,” as ApiJect dubbed it, that has been planned for N.C. remains unbuilt, NBC said.

ApiJect’s syringe is designed to be prefilled with a dose of a vaccine before it is shipped out to be used by doctors, pharmacists, hospitals, and many of the vaccination centers set up across the country. NBC noted that the prefilled technology had not been approved in the U.S. 

The design of the pre-filled device and the use with the specific vaccines will have to be authorized. Additionally, the U.S. Food and Drug Administration will have to determine if storing the vaccine in syringes will not cause any issues. 

ApiJect told NBC it “is working with several vaccine pharmaceutical companies to conduct the testing and regulatory reviews of Covid-19 vaccines in the ApiJect syringe.” The company also said two vaccine makers have requested the FDA to approve the use of its syringes but did not provide the names of the companies. 

In the United States, only three COVID-19 vaccines have received authorization for use, the two mRNA vaccines developed by Moderna and Pfizer and BioNTech, and the single-dose vaccine developed by Johnson & Johnson. 

According to the report, the syringe has yet to receive any nod of approval from the federal regulatory authorities. Also, a spokesperson for Pfizer told the news agency that even if the FDA greenlit the ApiJect syringes, it would have little to no impact on the continued output of its mRNA vaccine. 

Moderna didn't respond to a request for comment, and Johnson & Johnson declined to comment, NBC said. 

When the first portion of the nearly $1.3 billion in total funds awarded to ApiJect was announced, the government said the financing would “enable the manufacture of more than 100 million prefilled syringes for distribution across the United States by year-end 2020.”

The Gigafactory in North Carolina’s Research Triangle Park is still in the earliest stages of construction. 

ApiJect spokesperson Steve Hofman told NBC the land for the site has been cleared and graded for construction. However, there was no indication when construction would begin.

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