Johnson & Johnson announced Wednesday, March 31, that a batch of its COVID-19 vaccine could not be used because it did not meet quality standards. Specifically, a vaccine ingredient made by Emergent BioSolutions at its Baltimore factory failed to meet quality standards. Johnson & Johnson said the factory, known as Bayview, had not yet been approved by the FDA to make part of the vaccine.
It was unclear how many doses had been discarded and how the problem would affect future deliveries of Johnson & Johnson's vaccine. But it was clear from the start that Emergent is a disaster waiting to happen for Johnson & Johnson. (Related: Johnson & Johnson threw out 15 MILLION DOSES of its coronavirus vaccine after sloppy worker mixed in the WRONG ingredient.)
The little-known company has had a string of citations from the FDA for quality control problems. The FDA inspected Emergent's Bayview plant just as its link-up with Johnson & Johnson was being announced in April last year. The agency described the facility as a contract testing laboratory that "did not manufacture products for distribution."
Technology and personnel upgrades required at Bayview
Upgrades in technology and personnel were required before Bayview could begin making a drug substance material for the Johnson & Johnson vaccine, a two-month process during which the required biological cells are grown.
Records obtained by the Associated Press through the Freedom of Information Act revealed that the FDA criticized Emergent for problems with its testing of a potential treatment for anthrax during the April 2020 inspection.
The FDA's lead investigator, Marcellinus Dordunoo, cited the company for failing to train employees "in the particular operations they perform as part of their function and current good manufacturing practices."
Other problems cited by the FDA during the inspection included failures by the Bayview plant to ensure that electronic data generated through testing of drug ingredients "was protected from deletion or manipulation."
A closer review found 202 deletions and 543 reprocessed files, yet the company did not investigate how those alterations had occurred or their possible effects. Dordunoo wrote in his report that Emergent had not investigated the issues he described as "data integrity concerns."
The FDA also criticized Emergent for not following proper testing and lab procedures and for carelessness in the handling of rejected materials in the Bayview plant.
According to the FDA, deviations from test methods are not investigated by the company "and are manually corrected days after performance, with no supporting data or documented justification." An inspector also observed that items in a "reject cage" did not have reject labels, and wrote in the report that "separate or defined areas to prevent contamination or mix-ups are deficient."
The inspection was not triggered by the company's link-up with Johnson & Johnson, but the issues listed by FDA inspectors stood out due to the large role Emergent would soon have to combat the pandemic.
FDA has a series of critical reports concerning Emergent
Emergent is one of about 10 companies that Johnson & Johnson is using to speed up manufacturing of its recently approved vaccine. Johnson & Johnson heralded its partnership with Emergent as a step toward its goal of supplying more than 1 billion doses of COVID-19 vaccine globally by the end of 2021.
The pharmaceutical giant apparently missed the series of critical reports from the FDA about Emergent.
Following a December 2017 inspection at a plant in Canton, Massachusetts, the FDA reported that Emergent hadn't corrected "continued low level mold and yeast isolates" found in the facility.
Nearly a year later, the FDA questioned why Emergent had "an unwritten policy of not conducting routine compliance audits" at a separate plant in Baltimore, known as Camden, where an anthrax vaccine is put into vials.
FDA inspectors noted that the company's processes there were flawed. "Your firm received 3 complaints for residue on the outside of the vials for 3 different lots," the FDA's inspection report said. Tests on that residue confirmed it was the vaccine, according to the report.
In another 2018 inspection, the FDA noted Emergent's ongoing problems managing contamination at the Baltimore facility where BioThrax is produced.
"Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not adequately established and followed," the FDA report stated.
FDA's inspectors also noted that Emergent staff filling vials of vaccine held "their hands directly above open vials" in a way that violated sterility safeguards.
Despite the string of citations for quality control problems, Emergent's revenues skyrocketed in recent years – jumping from about $523 million in 2015 to more than $1.5 billion in 2020. The company has invested heavily in lobbying the federal government, spending $3.6 million on lobbying in 2020 alone.
U.S. can do without Johnson & Johnson doses
The federal government has ordered enough two-dose shots from Pfizer and Moderna to vaccinate 200 million people, which should be delivered by late May. It has also ordered 100 million single-dose shots from Johnson & Johnson. (Related: Man's skin PEELING OFF after taking Johnson & Johnson COVID vaccine.)
A federal official said Wednesday evening that the Biden administration's goal of having enough vaccines for all adults in the U.S. by the end of May could be met without additional Johnson & Johnson doses.
Meanwhile, White House Press Secretary Jen Psaki said Thursday, April 1, that none of the Johnson & Johnson vaccine doses on the market are affected and the company was on track to deliver 24 million doses in April and 100 million doses by the end of May.
"These are doses that the U.S. government has purchased, but we also have plenty of doses from Pfizer and Moderna, regardless," Psaki said.
A Johnson & Johnson spokesman said earlier Wednesday that the company met the end-of-March goal. The Centers for Disease Control and Prevention's online vaccine tracker showed that Johnson & Johnson had provided about 6.8 million doses to the U.S. vaccine effort. Reports said Johnson & Johnson has been shipping finished vaccines from its factory in the Netherlands to the U.S.
Johnson & Johnson said it was putting more of its manufacturing and quality experts inside Emergent's factory to supervise production. The FDA authorized Johnson & Johnson's COVID-19 vaccine on Feb. 27.
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