Emergent BioSolutions plant that ruined Johnson & Johnson vaccine doses had prior FDA violations

WASHINGTON — In April last year, an investigator from the Food and Drug Administration reported problems he had discovered at a Baltimore plant operated by Emergent BioSolutions, a major supplier of vaccines to the federal government.

Some employees had not been properly trained. Records were not adequately secured. Established testing procedures were not being followed. And a measure intended to “prevent contamination or mix-ups” was found to be deficient.

Soon after the inspection, Emergent’s Baltimore plant was given an important role in Operation Warp Speed, the government’s program to rapidly produce vaccines to fight the coronavirus pandemic. Emergent was awarded $628 million by the government and also secured deals totaling more than $740 million with Johnson & Johnson and AstraZeneca to produce coronavirus vaccines for both companies at the Baltimore site.

It emerged on Wednesday that a batch of Johnson & Johnson vaccine was recently contaminated with AstraZeneca ingredients at the Emergent plant, a mix-up that spoiled enough raw vaccine for up to 15 million doses.

The FDA report was dated April 20, less than six weeks before Emergent’s Warp Speed award was announced on June 1.

Emergent spokeswoman Nina DeLorenzo said in email Thursday: “Emergent has hosted two subsequent onsite FDA visits associated with our COVID vaccine efforts that include reviews of the progress on the items cited in past FDA visits.”

A copy of the FDA investigator’s report was obtained by The Washington Post via the Freedom of Information Act. The Associated Press reported on the report earlier on Thursday. The Post also found that the mishandling of the Johnson & Johnson vaccine followed an allegation of another serious error by Emergent on a separate vaccine project for ricin involving the same Baltimore plant. That allegation, which has not previously been reported on, is contained in a Securities and Exchange Commission filing.

Emergent’s $628 million Warp Speed deal was made as part of a long-standing contract between the company and the office in the Department for Health and Human Services (HHS) responsible for preparing for public health threats.

At the time of the award, that office was led by Assistant Secretary Robert Kadlec. The Post previously reported that before joining the Trump administration, Kadlec was paid as a consultant to Emergent and formed a startup company with Emergent’s chairperson. Kadlec did not mention either role in a questionnaire about his career that he completed for the Senate when it considered his nomination by Trump in 2017. Kadlec and Emergent previously told The Post that Kadlec’s past work for Emergent had no bearing on the firm’s government contracts.

Regarding the ruined batch of Johnson & Johnson vaccine, Emergent said Thursday that the problem was caught through routine quality checks and that none of the contaminated vaccine was shipped from the plant.

Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, confirmed on CBS Thursday that the spoiled batch amounted to 15 million doses of vaccine.

Emergent said it remained confident it would meet timetables of its customers, Johnson & Johnson and AstraZeneca, as well as the government’s. The complex process of manufacturing vaccine sometimes results in batches being discarded, Emergent said.

“There are rigorous quality checks throughout our vaccine manufacturing processes, and through these checks a single batch of drug substance was identified that did not meet specifications and our rigorous quality standards,” the company said in a statement. “We isolated this batch and it will be disposed of properly.”

Outside experts agreed that vaccine batches sometimes need to be thrown out for any number of reasons but said that mixing of ingredients from two different products was highly uncommon.

“All vaccines have batches that don’t meet specifications and need to be discarded, even vaccines with decades of experience. Vaccines involve biology even more than chemistry, and so there is variability. And human beings are involved at every step,” said John Grabenstein, scientific director of the Immunization Action Coalition, which is a clearinghouse of science-based vaccine knowledge, and former global director of medical affairs for Merck vaccines for 13 years.

“I cannot recall another instance where two different products had a mix-up within the same facility,” he said. “The present situation is probably not unprecedented, but it is unusual.”

Johnson & Johnson did not comment Thursday. It said on Wednesday that it was adding layers of supervision at the Emergent plant to directly monitor production.

The White House on Thursday referred questions about problems at Emergent to the FDA. The FDA declined to comment. “FDA is limited in its ability to disclose information about specific manufacturers and production facilities,” FDA spokeswoman Abigail Capobianco said in an email. AstraZeneca did not respond to requests for comment.

Emergent’s coronavirus vaccine production line has not yet been certified by the FDA, federal officials have said. The FDA, Emergent and Johnson & Johnson have not publicly discussed why this is. Until the certification is final, vaccine made there cannot be distributed to consumers. In the meantime, Johnson & Johnson has been shipping vaccine made in the Netherlands for U.S. supply.

DeLorenzo, the Emergent spokeswoman, said the company had been “diligently working through all questions raised by the FDA” as part of the process.

The company does not expect the latest episode will result in a “significant delay” of the certification, Emergent CEO Bob Kramer said on CNBC Thursday.

Emergent, a well-connected firm with a formidable lobbying operation in Washington, has in recent years been the highest-paid contractor to the office of the Assistant Secretary for Preparedness and Response at HHS.

The Post reported last year that Emergent had benefited from billions of dollars in federal contracts as health officials directed public spending toward the threat of bioterrorism attacks at the expense of some preparations for a pandemic.

The FDA inspection of Emergent’s Baltimore Bayview campus took place from April 9 to April 20 last year, before it had been tapped to manufacture coronavirus vaccine. Inspectors found holes in Emergent’s training procedures. “Employees are not given training in the particular operations they perform as part of their function and good manufacturing practices,” the inspection report said.

An employee who prepared a solution was found to not have documented the work, and no record could be found that the person had been trained in the procedure, the report said. It said 26 other employees could not be traced in training logs.

The inspection found that Emergent had “deficient” holding areas for holding rejected manufacturing components “to prevent contamination and mix-ups,” according to the report. It said filters in a holding area for rejected components lacked proper documentation.

The contamination of Johnson & Johnson vaccine followed allegations last year of an Emergent error during the development of another vaccine, which a company spokeswoman said was worked on at Emergent’s Baltimore facility and a second site in Maryland.

Soligenix, a company partnering with Emergent to develop a vaccine against ricin poisoning, said in a securities filing last August that Emergent had supplied it with drugs that were out of specification. By the time Emergent flagged the error, two participants in a study of the vaccine had been given doses, according to the filing by Soligenix, which said the study was suspended and the subjects were monitored.

The Soligenix-Emergent project was funded by a $21 million contract with HHS, and Soligenix has said it hopes to supply the ricin vaccine to the Strategic National Stockpile. Soligenix said in the filing that Emergent informed it of the error in January 2020 and that HHS then declined in April 2020 to provide further funding for clinical trials of the ricin vaccine. Soligenix did not state whether the two facts were connected or whether it had alerted the government to Emergent’s alleged error. An HHS spokesman did not respond to questions.

An internal review of the error by Emergent found “multiple internal failings,” according to the Soligenix filing, which said it had confirmed those failings with its own audit.

Soligenix is seeking $19 million in damages from Emergent in arbitration proceedings, the company said in the filing. Soligenix alleges that Emergent was unjustly enriched, was negligent, fraudulently induced Soligenix into entering into contracts and breached contracts. Soligenix said in a more recent filing that Emergent had denied the allegations.

DeLorenzo, the Emergent spokeswoman, said Thursday that the company denied it was liable for the damages but could not say more because of the confidential terms of the arbitration process. “Emergent will continue to defend itself in the arbitration until it is resolved,” DeLorenzo said.

This story was originally published at washingtonpost.com. Read it here.