Executives from Emergent BioSolutions were grilled by members of Congress this week, leading to a number of revelations about the CDMO’s handling of COVID-19 vaccine manufacturing.
The Wednesday hearing was held by the Select Subcommittee on the Coronavirus Crisis, who asked Emergent’s CEO, Robert Kramer, and its executive chairman, Fuad El-Hibri, to answer questions in response to a manufacturing mishap that led to 15 million doses of the J&J vaccine being scrapped.
Long a top biodefense contract manufacturer used by the U.S. government, Emergent’s Bayview facility in Baltimore was tapped in 2009 to become a part of BARDA’s pandemic-response manufacturing infrastructure. When the COVID-19 pandemic struck, the government issued a task order leveraging the plant to make the bulk drug substance for the J&J and AstraZeneca candidates.
This spring, a mix-up involving ingredients for the two vaccines caused the contamination of the J&J vaccine batch. Shortly afterward, the FDA issued a Form 483 to the company for a number of quality observations, leaving the plant idle until the concerns are addressed.
Since then, questions have swirled around the company’s lobbying for government contracts, stocks sell-offs by executives and past quality issues at the plant.
In the hearing, Democrats were sharply critical of Emergent, complaining about the company winning a “no bid contract” and calling out the executives for their pay and stock options. Maxine Waters (D-Calif.), even accused the executives of “insider trading.” (Kramer says that the stock sell-offs were pre-planned and not in response to issues at the plant.)
Republicans were much more forgiving, complimenting the company for successfully producing a number of medical counter measures for the government over the years. Instead of questioning the executives, most Republicans used the occasion to rail against President Biden’s potential support of waiving IP rights for vaccines and complain that not enough has been done to investigate the origins of the novel coronavirus.
Despite the partisan posturing, Kramer revealed a number of details about what’s been going on at Emergent:
No vaccines produced at Emergent’s plant have been used by Americans: Given the contamination issues, Emergent has yet to deliver any bulk drug substance used to make a vaccine administered in the U.S.
The contamination issue was detected by J&J in the Netherlands: In the hearing, Kramer said that its internal quality control program first detected the contamination. Yet, he acknowledged that the lab that ran the assay was at a J&J plant in the Netherlands. He also noted that J&J’s assays are a part of Emergent’s overall quality program.
Emergent “doesn’t know” what exactly caused the mix-up leading to the contamination: Although Kramer said that Emergent has discovered what led to the cross contamination, the company still doesn’t know how exactly it happened. Here’s what Kramer said: “The cross contamination occurred as a result of material that was leaving the AstraZeneca suit following a production cycle and production run, and as it was being exited out of our facility it came in the general vicinity of some media that was being prepared for the initiation of a J&J run. We don’t know how exactly the virus of the AstraZeneca product was transferred into the media, but somehow it was.”
In his testimony, Kramer repeatedly noted the challenges with rapidly scaling up two vaccines at once and manufacturing them in the same facility.
The company is still sitting on enough batches of J&J’s bulk drug substance to make 100 million doses of its vaccine: According to Kramer, the company has produced enough of the key ingredient for 100 million doses of the J&J vaccine, but they are waiting for the FDA to complete a quality review of the product before it can be released to the public.
The company could be up and running “within days:” When Emergent was issued its Form 483 in late April, analysts initially worried that it could take months for the company to resolve the observations and once again begin production. But Kramer said the company could now be back online within days.
