The U.S. government's $628 million mistake - DPF

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The U.S. government’s $628 million mistake

Story at a glance

  • Last week Emergent Biosolutions, a biotech firm known for producing anthrax vaccines, revealed they are destroying 15 million doses’ worth of the Johnson & Johnson vaccine after cross contamination with AstraZeneca vaccine was discovered.
  • Emergent’s Baltimore location was funded by the federal government (and built with taxpayer support) more than eight years ago as an attempt to secure a facility which specialized in mass production of vaccines in case a pandemic were to arise.
  • Last June, the federal government paid Emergent $628 million to act as the United States’ main facility for COVID-19 vaccine manufacturing.
  • An assessment was released just days after the contract with Emergent was signed. It warned the government of “key risks” and addressed that the company “will have to be monitored closely”.
  • This is due to the lack of fulfilling promises from the company’s past. They were unable to meet demands during a test run of mass-vaccine production yet were still endorsed by the federal government.
  • Since the start of the manufacturing, audits and investigations have revealed that the company “had not followed some basic industry standards” and there were “repeated shortcomings in efforts to disinfect and prevent contamination”.
  • The FDA has not certified the factory to distribute any doses until they perform weeks-long investigations.
  • The sudden onset of vaccine manufacturing-related drama only reveals another consequence of rushing mass vaccination efforts.

Unpromising background

In 2012, the Department of Health and Human Services awarded three contracts (one to Emergent Biosolutions so that they could expand their Baltimore site) to ensure domestic sites for mass-vaccine manufacturing in case of crisis.

Between 2015 and 2019 the site mainly manufactured smaller batches of vaccines for various viruses.

A pressure-test was assigned to Emergent in 2019, who had to produce up to 50 million doses of a vaccine within four months. However, as the deadline neared, the company could not keep up.

Dr. Kadlec, who ran the office overseeing the contract, “concluded in 2019 that their ability to deliver in a pandemic remained largely unproven.” (1)

By June 2020 (the pressure-test deadline), Emergent had not met the requirements. However, the federal government still chose to award them a $628 million contract to manufacture COVID-19 vaccines.

Red flags:

  • Emergent auditors found mold in the room where cell cultures were grown on multiple occasions.
  • In October and January, Emergent discarded five lots of AstraZeneca vaccine due to suspected contamination, according to internal logs.
  • In November, a batch of Johnson & Johnson vaccine was destroyed after workers hooked up the wrong gas line and suffocated cells where the virus for the vaccine is grown.
  • A New Jersey company called Soligenix hired Emergent to produce an experimental vaccine against the toxin, ricin. However, in December 2019 Emergent told Soligenix that they did not properly test the vaccine before releasing it. Soligenix halted their clinical trial after 2 volunteers had already received doses. Now, Soligenix is seeking $19 million in damages from Emergent.
  • Johnson & Johnson’s auditors said that monitoring reports for bacteria and/or other contaminants were typically filed four to six months late.
  • AstraZeneca’s auditors found that Emergent loosened monitoring criteria so that it appeared they had met them.
  • One former official said that a senior manufacturing supervisor responded to reports of quality errors by asking: “Do you want me to make drugs or fix issues?” I don’t have time to do both.” (2)

Facing the consequences

Emergent Biosolutions was unreliable from the start. There were red flags before they were awarded the hefty contract and continued to live up to their less-than-stellar expectations throughout the manufacturing period.

An assessment written by Carlo de Notaristefani, a manufacturing expert who has overseen production of COVID-19 vaccines for the federal government since last May, was released just days after the contract with Emergent was signed. He highlighted “key risks” and addressed that the company “will have to be monitored closely”.

The $628 million consequence of the federal government’s decision comes from the Trump administrations “Operation Warp Speed” plan which aimed to speed the process of manufacturing vaccines for mass distribution in an impossibly short amount of time.

This past Saturday, the Biden administration put Johnson & Johnson in charge of the manufacturing plant in light of the troublesome events. The site now only manufactures Johnson & Johnson vaccines and has halted AstraZeneca manufacturing altogether.

However, if anything, this only shows the expected consequences of rushing mass vaccination efforts. This is a multi-layered aspect that runs deep through the pandemic. The blood-clotting incidents from the AstraZeneca vaccine and the adverse reactions from Moderna and Pfizer vaccinations (from the hands of less-than-thorough clinical trials), the ill-advised and deceitful manufacturing plants… They all stem from the irrational pressure from the government to instill mass vaccination efforts on its citizens.