Chairs Maloney, Clyburn Reveal that Quality Failures by Emergent BioSolutions Rendered 135 Million Additional Coronavirus Vaccine Doses Unusable
Washington, D.C. (August 11, 2022)—Today, Rep. Carolyn B. Maloney, Chairwoman of the Committee on Oversight and Reform, and Rep. James E. Clyburn, Chairman of the Select Subcommittee on the Coronavirus Crisis, released new evidence that 135 million coronavirus vaccine doses manufactured at Emergent BioSolutions’ (Emergent) Bayview facility in Baltimore, Maryland between August 2021 and February 2022 were designated for destruction following the discovery of quality deficiencies. A May 2022 staff report by the Committees revealed that 390 million doses had previously been destroyed due to Emergent’s failure to address quality concerns. The rejection of the additional 135 million doses—which were manufactured after the plant had purportedly addressed earlier deficiencies and resumed manufacturing—brings the total number of doses wasted due to Emergent’s failure to meet or maintain quality standards to over 525 million.
Chairwoman Maloney released the following statement:
“Once again, our Committees have found evidence that unacceptable and irresponsible business practices by Emergent BioSolutions have limited our ability to meet the urgent, global need for coronavirus vaccines. Companies benefitting from taxpayer dollars intended to produce vaccines must put the public good first. By repeatedly failing to meet quality standards even after being notified of serious problems, Emergent BioSolutions has wasted hundreds of millions of vaccine doses and violated the public’s trust.”
Chairman Clyburn released the following statement:
“Today’s findings confirm that the Biden Administration was right to cancel the Trump Administration’s coronavirus vaccine manufacturing contract with Emergent BioSolutions last year. It is deeply disappointing that Emergent, after collecting millions in taxpayer dollars and having many months to fix the serious manufacturing problems plaguing their Baltimore facility, has yet to competently perform the essential task they committed to perform. Their continued failure has hampered vaccination efforts in areas of the world where vaccines are still in short supply. Emergent executives clearly have a great deal of work to do to eliminate these systemic problems at their company. Taxpayer dollars must never again be wasted so egregiously.”
New evidence released by the Committees today reveals the following key findings:
An additional 135 million doses of taxpayer-funded coronavirus vaccines, manufactured after Emergent claimed to have addressed quality concerns, have been deemed unusable as a result of continuing deficiencies.
- At the time of the Committees’ May 2022 staff report, 135 million Johnson & Johnson coronavirus vaccine doses that had been manufactured at Emergent’s Bayview plant between August 2021 and February 2022 had been sequestered pending testing and regulatory approval. Johnson & Johnson recently informed the Committees that a batch of these doses failed inspection, rendering all 135 million doses not “usable” and necessitating their destruction. This increases the total number of wasted doses to 525.2 million based on information obtained by the Committees from Johnson & Johnson and AstraZeneca.
- Emergent claimed to have addressed quality concerns prior to restarting manufacturing in August 2021 after the Food and Drug Administration (FDA) found multiple deficiencies during June and July 2021 inspections. However, Johnson & Johnson representatives confirmed that “there continued to be issues” with manufacturing at the Bayview facility during the winter of 2021 to 2022.
Multiple foreign health authorities documented “adverse regulatory findings” and determined that Emergent’s Bayview facility did not comply with quality standards.
- New evidence obtained by the Committees shows that regulators from multiple countries documented adverse findings following audits of Emergent’s Bayview facility between February and April of 2022––confirming FDA’s previous findings that Emergent was not operating in compliance with current good manufacturing practices (GMP). These findings included:
- European Union: “[Emergent] has failed to demonstrate consistent production of viral vector vaccine drug substance in accordance to the EU GMP [European Union Good Manufacturing Practice] requirements and that contamination issues are still present and are not under control.”
- South Africa: “[T]he Authority is NOT satisfied that [Emergent] is operating at an acceptable level of compliance with the principles and guidelines of Good Manufacturing Practice….” South Africa issued Emergent a non-compliant rating on March 31, 2022, stating it would not “accept any drug products or drug substance manufactured at this facility until another Good Manufacturing Practice (GMP) inspection is completed, and the facility meets GMP requirements.”
- Canada: “[T]he activities conducted at [Emergent] are not compliant with Part C, Division 2 of the Food and Drug Regulations due to significant deviations from GMP requirements.” Canada assigned Emergent a non-compliant rating on March 24, 2022.
- This new information confirms that Emergent’s failures detailed in the Committees’ May 2022 staff report, including that the company did not comply with quality standards throughout its contract with the federal government, were not ameliorated sufficiently. The fate of these 135 million newly rejected doses appears to validate FDA’s warning last year that Emergent had not made needed corrective actions and the ten concerns outlined by FDA, including that “Responsibilities applicable to the quality unit [are] not fully followed,” “Employee Training [is] not adequately documented,” and “Procedures for transporting materials and waste are not followed.”
Senior Trump Administration official claimed to have been unaware of the full extent of the company’s failures.
- Dr. Robert Kadlec, the Assistant Secretary for Preparedness and Response during the Trump Administration, informed the Select Subcommittee during a transcribed interview that he was not told about federal regulators’ adverse findings against Emergent before the Biomedical Advanced Research and Development Authority (BARDA) awarded Emergent a $628 million contract to manufacture coronavirus vaccines on May 24, 2020. The Committees previously released evidence that FDA and BARDA conducted two inspections in April 2020 that warned of “substantial evidence of site cGMP non-compliance” and persistent problems with mold, poor disinfection of plant equipment, and inadequate training of employees at the Bayview facility.
- Dr. Kadlec also stated that he was unaware of additional audits conducted by Operation Warp Speed, BARDA, and FDA in June, July, and September 2020, which resulted in numerous “critical” observations against Emergent, outlined in the Committees’ May 2021 and May 2022 reports. Dr. Kadlec acknowledged that the findings were “kind of a big deal” and that “it seems like a drum beat of issues that were being raised.”
- Dr. Kadlec told the Select Subcommittee that he was unaware that a total of 15 batches—equivalent to roughly 61.2 million AstraZeneca and Johnson & Johnson coronavirus vaccine doses—were rejected or aborted due to microbial contamination and equipment failure between September and December 2020, although he was generally aware that concerns about Emergent’s manufacturing had developed during that time.
Johnson & Johnson representatives were alarmed by evidence of Emergent’s misconduct previously released by the Committees.
- Following the release of the Committees’ May 10, 2022, staff report, Johnson & Johnson notified Emergent on May 31, 2022, that it intended to send a notice terminating its manufacturing services agreement, effective July 6, 2022.
- Johnson & Johnson representatives briefed the Committees that they were alarmed by the Committees’ findings that Emergent employees hid evidence of potential quality issues in order to deceive FDA inspectors. According to one senior Johnson & Johnson representative, this “signaled a shift from capability to misconduct,” explaining that being “unable to manufacture something” is different than “withholding information.”
On April 19, 2021, the Committees launched an investigation into Emergent following reports of quality control issues and poorly trained staff at the company’s Bayview facility in Baltimore, Maryland. On May 19, 2021, the Select Subcommittee held a hearing with Emergent’s then-Chairman and CEO to address the company’s manufacturing failures. The Committees released findings from the investigation on May 19, 2021, and May 10, 2022.
Over the course of the investigation, the Committees obtained documents from Emergent, Johnson & Johnson, AstraZeneca, FDA, and the Department of Health and Human Services (HHS), held bipartisan staff briefings with representatives from Johnson & Johnson, AstraZeneca, FDA, and HHS, and conducted a staff site visit of Emergent’s Bayview facility.
Click to read the FDA’s reports on its June 2021 and July 2021 inspections of Emergent’s Bayview facility.