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Emergent BioSolutions — Select Subcommittee hearing transcript and staff report

Emergent Biosolutions — 2 court filings in the archive, mostly from Committee on Oversight and Reform / Select Subcommittee on the Coronavirus Crisis, 117th Congress, filed between May 19, 2021 and May 10, 2022.

Case facts

CourtCommittee on Oversight and Reform / Select Subcommittee on the Coronavirus Crisis, 117th Congress (1 filing); Committee on Oversight and Reform / Select Subcommittee on the Coronavirus Crisis (1 filing)
Filings2 public filings
Filed2021-05-19 – 2022-05-10

Case summary

This page collects two documents of the Committee on Oversight and Reform and its Select Subcommittee on the Coronavirus Crisis, 117th Congress: the transcript of the hearing "Examining Emergent BioSolutions' Failure to Protect Public Health and Public Funds," held May 19, 2021, printed as Serial No. 117-23, and a staff report dated May 2022, "The Coronavirus Vaccine Manufacturing Failures of Emergent BioSolutions." The staff report states it was prepared for Rep. Carolyn B. Maloney and Rep. James E. Clyburn following an investigation into the Trump Administration's award of a contract to Emergent BioSolutions, Inc. to manufacture coronavirus vaccines. It records that the Administration awarded Emergent a $628 million contract on May 24, 2020, that nearly 400 million vaccine doses were destroyed, and that according to HHS the company received $330 million before the contract was terminated in November 2021.

Case at a glance

PartiesIssuing bodies: the Committee on Oversight and Reform and its Select Subcommittee on the Coronavirus Crisis, 117th Congress. Subject of both documents: Emergent BioSolutions, Inc. Hearing witnesses: Robert G. Kramer, President and Chief Executive Officer, and Fuad El-Hibri, Executive Chairman of the Board of Directors (printed "Faud El-Hibri" in the contents)
Court and docketAgency / no docket. Hearing held May 19, 2021 before the Select Subcommittee on the Coronavirus Crisis, Serial No. 117-23, printed by the U.S. Government Publishing Office (44-686 PDF, 2021); staff report published May 2022
ProgramNo pandemic relief loan or benefit program is named in the filings on this page. Both documents concern a federal contract to manufacture coronavirus vaccines
ClaimsNot applicable. These are a printed hearing record and a committee staff report, not pleadings
Disposition or statusFindings published by the Committees. The staff report states that HHS concluded the government should not pay Emergent any additional money because it had not met its contract requirements to follow current good manufacturing practices, and that the Biden Administration terminated the contract in November 2021
Status checked2026-09-23 · against DOJ press releases through 2026-09-22; court docket not yet read

What did the staff report find?

Its key findings include that approximately 240 million doses had to be destroyed in late 2020 and early 2021, that the Food and Drug Administration released more than 180 million doses manufactured before a pause, that 90 million newly manufactured doses were destroyed after manufacturing resumed in July 2021 and 135 million remain sequestered pending further testing, and that Emergent employees removed quality-assurance records immediately before an FDA site visit in February 2021.

What contract is at issue?

A $628 million contract awarded on May 24, 2020 to support the manufacturing of Johnson & Johnson and AstraZeneca coronavirus vaccines, which required Emergent to maintain the cleanliness and readiness of its facilities, equipment and personnel. The report states Emergent separately contracted with Johnson & Johnson and AstraZeneca for $482 million and $174 million respectively.

Who testified at the May 2021 hearing?

The printed contents list two witnesses, both of Emergent BioSolutions, Inc.: Robert G. Kramer, President and Chief Executive Officer, and Fuad El-Hibri, Executive Chairman of the Board of Directors. The hearing was held before the Select Subcommittee on the Coronavirus Crisis on May 19, 2021.

Summary written from the documents on this page; every sentence is sourced.

Filings

2 public filings from this case, in filing-date order.

  1. Examining Emergent BioSolutions' Failure to Protect Public Health Funds — Hearing Transcript (May 19, 2021)
  2. The Coronavirus Vaccine Manufacturing Failures of Emergent…

Court, dates and docket numbers are as recorded on the filings.

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