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Baltimore vaccine maker hid problem from FDA inspectors, House report says

Emergent BioSolutions has been under fire since March 2021, when it ruined millions of doses of Johnson & Johnson coronavirus vaccine

Bad training, poor sanitation and improper procedures were among the numerous problems at Baltimore’s Emergent plant that ruined 400 million vaccine doses in all, according to a House panel report.
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Emergent BioSolutions concealed evidence last year from Food and Drug Administration inspectors of a potential problem with batches of coronavirus vaccines in the weeks before a contamination incident destroyed millions of doses, a House panel said Tuesday in a harsh report on failures at Emergent’s Baltimore plant.

The joint investigation report by the House select subcommittee on the coronavirus crisis and the Oversight and Reform Committee reinforced the negative portrait that emerged last year after the Food and Drug Administration suspended vaccine manufacturing at the plant.

Cross-contamination of coronavirus vaccines being made for Johnson & Johnson and AstraZeneca was discovered in March 2021. The company had more than $1.3 billion worth of contracts from the federal government and from Johnson & Johnson and AstraZeneca to make the vaccines. No contaminated doses made it into the public vaccine supply. But the firm’s failures rank among the worst government procurement efforts during the pandemic, sparking the House investigation that began more than a year ago.

The panel’s report Tuesday — which added detail to findings it issued on a preliminary report last year — said bad training, poor sanitation, improper procedures, unclean conditions and numerous other problems at the plant ruined 400 million doses in all.

Emergent said Tuesday it has been fully cooperative with government agencies and its manufacturing partners. It said the committee’s estimate of 400 million doses destroyed is inaccurate, based on a poor understanding of biomedical manufacturing.

“Emergent has been open and forthcoming with the FDA, Congress and our partners about the work at our Bayview site and the challenges that were encountered including providing thousands of documents, willingly participating in a congressional hearing and inviting them to visit our facilities,” Emergent spokesman Matt Hartwig said in an email.

“During the last few years, the FDA and other international regulatory authorities have visited Emergent facilities dozens of times,” he added. Johnson & Johnson and Emergent told the FDA about the single contaminated batch in March 2021, he said.

In a new finding in the subcommittee’s latest report, the panel report said employees removed yellow “hold tags” from two containers containing newly manufactured Johnson & Johnson vaccine one hour before FDA inspectors arrived at Emergent’s Bayview facility in Baltimore in February 2021 to conduct a site tour. The hold tags indicated a potential quality problem with the vaccine in the containers, the House panel found. After the FDA inspectors left, employees put the tags back on the containers.

House staff investigators obtained an email from a consultant working for Emergent that stated “the purpose of removing the … [quality assurance] hold tags was to avoid drawing attention to the two subject containers during the tour by the FDA inspectors.”

A week earlier, Emergent officials had rebuffed efforts by Johnson & Johnson quality staff to personally inspect the facility, according to the House panel’s report. Both the FDA and Johnson & Johnson were scrutinizing operations after previous findings in 2020 that the plant was poorly prepared to produce vaccine as the pandemic raged out of control.

In another incident, the investigators reviewed an email from March 2021 in which an Emergent official told another executive to not disclose details of the contamination problems to the Biomedical Advanced Research and Development Authority, the federal government’s main pandemic contracting arm, after BARDA questioned the company about the unfolding crisis.

“The investigation revealed that Emergent took repeated steps to conceal its quality failures from the federal government and other third parties by limiting access to Bayview, tampering with drug-substance labels to impede FDA oversight, and strategizing to withhold information from [the Department of Health and Human Services] following the cross-contamination event in March 2021,” the report found.

After discovery of cross-contamination, the Biden administration suspended the plant’s production of the Johnson & Johnson vaccine in April and permanently halted production of the AstraZeneca vaccine at the plant. After a three-month pause for extensive cleaning and remediation to fix systemic problems, including poor training of employees, the FDA permitted Johnson & Johnson vaccine manufacturing to resume there. But even after the restart in August, problems continued, according to the House report.

Out of 15 batches of the vaccine started between August 2021 and February 2022, six batches were either stopped before completion or rejected by Johnson & Johnson, the investigation found. The remaining nine batches were still being inspected and had not been cleared for distribution.

It is not uncommon in vaccine manufacturing to have to stop production because the vaccine substance was out of specification, experts have told The Washington Post.

The FDA and Emergent have said that all contaminated vaccine from the plant was kept out of the pandemic supply line, and that none of it made it into shots given to people. AstraZeneca’s vaccine has not been approved for use in the United States. The FDA placed new restrictions on Johnson & Johnson’s coronavirus vaccine, saying the risk of a rare and life-threatening blood clot syndrome outweighed the benefits of the vaccine for people who are 18 or older and can get another shot, unless they would otherwise remain unvaccinated.

The Biden administration terminated Emergent’s contract in November 2021, a move applauded Tuesday by Rep. James E. Clyburn (D-S.C.), chairman of the House select subcommittee on the coronavirus crisis. The subcommittee released early findings in May 2021. On Tuesday, Clyburn said Emergent ruined hundreds of millions of doses of vaccine despite repeated warnings before and after the Trump administration awarded it a contract to make vaccine. Before the contract, the company had been designated by government health authorities as a center for pandemic emergency preparedness.

But when the time came to perform, Clyburn said, “Emergent executives prioritized profits over producing vaccines in a responsible manner that complied with FDA requirements.”

Rep. Carolyn B. Maloney (D-N.Y.), chairwoman of the Oversight and Reform Committee, said contracting authorities at the Department of Health and Human Services should learn from the Emergent experience. “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,” she said.

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