Emergent BioSolutions Ruined 400M Vaccine Doses, More Than Previously Known, According To Congressional Report

BALTIMORE (WJZ) --During the darkest days of the pandemic, Emergent BioSolutions' Baltimore facility emerged as a bright spot.

It was poised to make millions of doses of life-saving coronavirus vaccine on a government contract worth more than $600 million—a point of pride for the city.

WJZ was one of the first to get a tour as they ramped up in early 2021. 

Governor Larry Hogan soon got his own personal tour and sang Emergent's praises.

But problems quickly surfaced that vaccines were being contaminated and had to be thrown out.

Now, WJZ has obtained a new report from the House Oversight Committee that reveals almost 400 million doses had to be destroyed because Emergent "failed to maintain quality standards." That is significantly more than had previously been made public.

It alleges the company hid evidence from government inspectors by removing tags on contaminated batches of J&J vaccine before a visit from the FDA last year.

In March 2021, The New York Times reported 15 million doses of the Johnson & Johnson vaccine were destroyed after workers at the Bayview manufacturing plant conflated the ingredients for the vaccine with those of the Oxford-AstraZeneca shot.

Johnson & Johnson had to step in and take over manufacturing, and the Food and Drug Administration initiated an investigation.

In June, the Food and Drug Administration decided to discard at least another 60 million additional doses of the Johnson & Johnson vaccine produced at the plant.

In a statement, Rep. Carolyn Maloney (D-NY), chairwoman of the Committee on Oversight and Reform, said Emergent BioSolutions swept problems at its plant under the rug in order to land federal contracts.

"Ultimately, our report shows that Emergent's manufacturing failures and deceptive tactics led to the destruction of millions of doses of desperately needed vaccines," she said. "Emergent's business practices are simply unacceptable, and I urge the federal government to carefully consider future contracts in light of Emergent's failures."

The report also says Emergent ignored repeated warnings—and alleges "inexperienced staff and high staff turnover contributed to vaccine contamination."

Hogan reacted to the report Tuesday.

"I haven't read all the details. I heard about it.  This has been an ongoing issue with the problems there, and I don't have all the facts," Hogan said. "We're going to have to get to the bottom it. It's kind of a tragic situation that 400 million doses of vaccine were wasted and had to be destroyed. We could've used those back during the peak."

Rep. James E. Clyburn, chairman of the Select Subcommittee on the Coronavirus Crisis, said in a statement there were numerous red flags at the plant.

"These doses were squandered despite repeated warnings from employees, outside consultants, pharmaceutical companies, and FDA regulators that the company's manufacturing practices were unsafe and that it was unlikely to fulfill the contract recklessly awarded by the Trump Administration," he said. "Emergent executives prioritized profits over producing vaccines in a responsible manner that complied with FDA requirements."

Lawmakers grilled Emergent's CEO when the preliminary findings came out last year.

Congressional investigators obtained emails with then-Emergent Vice President Sean Kirk, who once toured the facility with WJZ.

He expressed concerns and wrote "room to improve is a huge understatement" and "the thing that keeps me up at night is overall perception of state of quality systems."

Emails from Emergent's then-Vice President from House report

The problems led President Joe Biden to abruptly cancel a visit to the facility. His press secretary faced questions about it last year.

Emergent has denied wrongdoing and told WJZ the company has been transparent with regulators. It disputes the report's claim that 400 million vaccine doses were ruined and says it never knowingly misled the FDA.

Emergent says, "While it is important to analyze past decisions to inform future plans, we must do so in the proper context and avoid the temptation to Monday morning quarterback with the benefit of what we know today."

The company also noted, "Emergent and our government partners were attempting to compress into a few months the development and scale up of drug substance manufacturing processes that normally take years."

The Biden Administration terminated the contract with Emergent to produce vaccines last November. The U.S. Food and Drug Administration allowed Emergent to resume COVID-19 vaccine production in August 2021. Emergent received $330 million in taxpayer funds before the federal government terminated the contract, the report said.

WJZ has covered the company extensively.

In:
• COVID-19 Vaccine
• COVID-19
• Coronavirus
• Baltimore City