Emergent tossed nearly 400M Covid-19 vaccine doses in Baltimore debacle, House report says
The exact number of doses lost in the Emergent BioSolutions mishap at its Baltimore plant has never been exactly determined. But a recent report from the US House select subcommittee on the coronavirus crisis says that the company might have destroyed nearly 400 million doses of Covid-19 vaccines after failures to meet quality standards.
The report came to the determination via requests for internal communications between Emergent executives, which the subcommittee alleges included efforts to hide evidence of contamination in “an attempt to evade oversight from government regulators.”
“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,” Rep. Carolyn Maloney (D-NY) said in a statement. “Ultimately, our report shows that Emergent’s manufacturing failures and deceptive tactics led to the destruction of millions of doses of desperately needed vaccines. Emergent’s business practices are simply unacceptable, and I urge the federal government to carefully consider future contracts in light of Emergent’s failures.”
Originally, it was said that between 75 million and 85 million doses of drug substance was destroyed after contamination. The report finds that 400 million doses were destroyed between April 2021 and August 2021. Emergent hid the evidence, the report alleges, by removing quality-assurance hold tags from J&J batches that indicated that the containers had quality issues, in an effort to avoid drawing attention from FDA inspectors. Emergent employees were worried that the Department of Health and Human Services was getting too involved in its operations after the AstraZeneca-J&J mixup.
The report also says that Emergent entered contracts with the two pharmas despite its awareness that technical operations were not up to snuff for at least a few years.
“Our risk is high!” A note from a senior director of quality said at one point. “We lack commercial GMP compliance maturity.”
The team at Emergent maintains that there is nothing new included in the report, however, and disputes the statement that 400 million doses of the vaccine were determined to me unusable, citing the difficulty that comes with estimating the dosage equivalent of drug substance that has not completed the manufacturing process.
“To equate these quality control actions with a ‘discarded dose’ figure displays a lack of understanding regarding the biomanufacturing process,” the statement said.
The CDMO maintains that it never knowingly misled the FDA or any of the partners involved in the manufacturing process. It also said that the first it heard of the subcommittee’s report was through the media.
“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,” the statement says. “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, J&J and AstraZeneca personnel onsite daily.”
The report says the President Donald Trump’s administration was aware of deficiencies that the company had highlighted at the Bayview site when it was awarded $628 million in funding back in May 2020. AstraZeneca personnel raised concerns to Emergent in July of 2020, noting that the site wasn’t prepared for commercial manufacturing, and internal J&J communications said that the pharma was unclear if Emergent would be good-to-go come game time.
“I am stating very loudly that this work is NON-CGMP compliant. And a direct regulatory risk,” an outside consultant told Emergent in November 2020.
The report also found that inexperienced staff and high turnover led to vaccine contamination, as the staff that was working wasn’t trained properly, and had little previous pharma experience.
In February, Emergent announced that its troubled Bayview plant would get a $100 million upgrade, as it started making scheduled upgrades early, and expected to be back in operation in Q2 2022. The work will allow for “additional non-pandemic work being done in Bayview down the road,” CEO Bob Kramer said, and help support the strengthening of J&J’s supply chain.
Right now, Emergent has a supply agreement for Sandoz’s generic Narcan, and plans to launch a live typhoid vaccine and cholera vaccine. It also has a supply deal with the US government for its anthrax vaccine, the drug that kicked off the company’s relationship with the government years ago.
