Vaccine box

The company at the center of quality problems that led Johnson & Johnson to discard 15 million doses of its coronavirus vaccine has a string of citations from U.S. health officials for quality control problems.

Emergent BioSolutions, a little-known company vital to the vaccine supply chain, was a key to Johnson & Johnson’s plan to deliver 100 million doses of its vaccine to the United States by the end of May. But the Food and Drug Administration repeatedly has cited Emergent for problems such as poorly trained employees, cracked vials, and problems managing mold and other contamination around one of its facilities, according to records obtained by The Associated Press through the Freedom of Information Act. The records cover inspections at Emergent facilities since 2017.

Johnson & Johnson said last Wednesday that a batch of vaccine made by Emergent at its Baltimore factory, known as Bayview, cannot be used because it did not meet quality standards. It was unclear how many doses were involved or how the problem would affect future deliveries of J&J’s vaccine. Doses delivered in the U.S. to date have been shipped from its factory in the Netherlands.

“Human errors do happen,” Dr. Anthony Fauci, the nation’s top infectious disease expert, said last week in an interview on CBS’ “This Morning.” “You have checks and balances. ... That’s the reason why the good news is that it did get picked up. As I mentioned, that’s the reason nothing from that plant has gone into anyone that we’ve administered to.”

The FDA inspected Emergent’s Bayview plant in April 2020, just as the agreement with J&J was being announced. The federal agency criticized Emergent for problems with its testing of a potential treatment for anthrax. Although the FDA inspection was not triggered by work on a COVID-19 vaccine, the issues listed by agency inspectors stand out due to the large role Emergent would soon have to combat the pandemic.

The FDA criticized the Bayview plant for failing 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 had not investigated how those alterations had occurred or their possible impact, according to the records.

Emergent also did not follow proper testing and lab procedures and was criticized by the FDA for carelessness in the handling of rejected materials in the Bayview plant. An inspector observed items in a “reject cage” that did not have reject labels, and wrote that “separate or defined areas to prevent contamination or mix-ups are deficient.”

The inspection was the most recent in a series of critical reports from the FDA about Emergent, including one following a December 2017 inspection at a plant in Canton, Massachusetts, in which the FDA said the company had not corrected “continued low-level mold and yeast isolates” found in the facility.

In a June 2018 inspection, the FDA noted that the company’s processes in Baltimore 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 vaccine, according to the report.

The agency, in another 2018 inspection, noted “Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not adequately established and followed.” FDA’s inspectors pointed out that Emergent staff filling vials of vaccine held “their hands directly above open vials” in a way that violated sterility safeguards.

The FDA declined repeated requests to discuss the inspections at Emergent facilities. A spokesman said the agency “cannot comment on any particular company or any potential or ongoing compliance matters.”

Emergent is one of about 10 companies that Johnson & Johnson is using to speed up manufacturing of its recently approved coronavirus vaccine, the company said. The Bayview factory where the tainted vaccine ingredient was found had not yet been approved by the FDA, so no vaccine in circulation is affected. Emergent declined to comment.

A federal official said last Wednesday that the administration’s goal can be met without additional J&J doses.

J&J said it was putting more of its manufacturing and quality experts inside Emergent’s factory to supervise production of the COVID-19 vaccine, a move meant to enable delivery of an additional 24 million vaccine doses through April.

J&J said it still expects to deliver more than 1 billion vaccine doses globally by the end of the year.

The J&J vaccine has been viewed as crucial for vaccination campaigns around the world because only one shot is required and it can be shipped and stored at standard refrigeration temperatures, unlike some other vials that must be kept frozen. The company also has pledged to sell the vaccine without a profit, but only during the pandemic emergency.