400M COVID-19 vaccine doses dumped by Baltimore plant, congressional report finds

The Maryland-based vaccine maker Emergent Biosolutions was forced to destroy nearly 400 million doses of COVID-19 vaccine because of potential contamination at its East Baltimore plant, far more than previously known.

Further, the company sought to hide deficiencies from federal and outside inspectors at the site, built with millions of dollars of federal support, and continued to promote its manufacturing capabilities despite warnings of those deficiencies.

This is according to a final report expected to be released Tuesday after a year-long investigation by the House of Representatives’ Select Subcommittee on the Coronavirus Crisis, a panel that previously found significant flaws in the Trump-era deal to pay Emergent hundreds of millions to make vaccine.

Rep. Carolyn B. Maloney, chairwoman of the Committee on Oversight and Reform, said Emergent’s failures cost “desperately needed vaccines,” in addition to public funds, in a statement ahead of the report’s release.

“Today’s report shows that Emergent profited from the pandemic while violating the public’s trust,” said Maloney, a New York Democrat. “Despite major red flags at its vaccine manufacturing facility, Emergent’s executives swept these problems under the rug and continued to rake in taxpayer dollars.”

Added Rep. James E. Clyburn, subcommittee chair and a South Carolina Democrat: “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.”

The report, called “The Coronavirus Vaccine Manufacturing Failures of Emergent Biosolutions,” is based on visits to the Bayview facility plus interviews, internal correspondence and documents from Emergent, regulators and the vaccine developers Astrazeneca and Johnson & Johnson.

It follows initial findings released last May from the panel and is another blow to the company once known for its central role in the country’s vaccine preparedness. It now faces regulatory scrutiny and shareholder complaints. Emergent’s founder and executive chairman, Fuad El-hibri, stepped down in April and died last week.

Even before the coronavirus pandemic began in 2020, Emergent had long been a major supplier of government stockpiles of anthrax and smallpox vaccines and other biodefense-related vaccines and treatments. Three years after a major flu pandemic in 2012, federal health officials gave Emergent $163 million to ready the Bayview plant to produce vaccine for any novel virus.

Despite early warnings from federal inspectors about potential quality control problems at the Bayview plant, the latest report alleges the Rockville-based company secured a $628 million deal to make Astrazeneca and Johnson & Johnson vaccines from Trump administration officials.

The plant never won formal authorization from federal drug regulators for the manufacturing lines and last year was forced to pause production of vaccines for three months as inspectors assessed potential cross-contamination of the products.