Emergent BioSolutions' COVID-19 vaccine manufacturing woes were well documented in 2021, but a new congressional probe found that the company's problems went much further than realized.
Emergent's manufacturing setbacks forced the company to toss vaccine materials equivalent to nearly 400 million doses, according to a Tuesday report from the House of Representatives' Select Subcommittee on the Coronavirus Crisis. That's much more than the 85 million doses the company and U.S. officials previously disclosed, The Wall Street Journal reports.
The report says Emergent had to toss 240 million doses in late 2020 and early 2021—before its COVID vaccine production issues became public knowledge. After Emergent's production pause in April 2021 through July 2021, the company tossed another 90 million doses. Expirations have forced the company to discard another 60 million doses, the report says.
Emergent’s failures cost public funds as well as “desperately needed vaccines," according to the congressional report. The company disputes many of the report's findings.
After conducting its probe, the committee found Emergent was warned multiple times that manufacturing programs at the facility could lead to contamination. Deficiencies included persistent problems with mold, poor disinfection of plant equipment and inadequate employee training.
Officials with both Johnson & Johnson and the Trump administration's Operation Warp Speed inspected Emergent's Baltimore site in June 2020. Both audits revealed subpar plant conditions and questionable employee practices. The issues were not remediated, leading to three sperate occurrences of mass vaccine contamination in October 2020, December 2020 and February 2021, according to the congressional report.
“We are not in full compliance yet—BUT—we are making [vaccine] batches NOW,” Emergent’s senior director of quality control wrote in an internal email, as disclosed in the report. “Our risk is high!”
Emergent disputes the claims of hundreds of millions of doses being destroyed and says the company has been “open and forthcoming” with the FDA, Congress and its partners. The company was “dismayed” that it heard of the report through the media. While the company admits that batches may “test out of specification for a variety of reasons,” it disputes the number reported.
“It is very difficult to estimate dose equivalents for batches that do not complete the manufacturing process or leave the facility to be turned into a vaccine,” Emergent spokesperson Matt Hartwig said in a statement.
“While it’s 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,” Hartwig said. “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. We were always transparent with our public and private partners about our process and capabilities and often welcomed BARDA, Johnson & Johnson and AstraZeneca personnel onsite daily.”
The company remains committed to being a “trusted partner of the U.S. and allied governments” and helping supply medical countermeasures for biological, chemical and nerve attack agents.
Emergant’s federal contracts have since been terminated by President Joe Biden in what the company says was a mutual decision.