Northwest Arkansas Democrat-Gazette
COMPANY KEY
in vaccine supply cited for violations.
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 single-shot 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 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 the problem would affect future deliveries of the vaccine. The company said it was still planning to deliver 100 million doses by the end of June and was “aiming to deliver those doses by the end of May.”
“Human errors do happen,” Dr. Anthony Fauci, the nation’s top infectious-disease expert, said Thursday 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.”
White House press secretary Jen Psaki said Thursday that none of the J&J 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.”
Johnson & Johnson locked arms with Emergent in April 2020, enlisting the company to manufacture the vaccine Johnson & Johnson was developing with federal money. At the time, Emergent’s Bayview facility wasn’t scaled for making millions of doses of a potential covid-19 vaccine, according to the FDA records, which describe the plant as a contract testing laboratory that “did not manufacture products for distribution.” Upgrades in technology and personnel were required before Bayview could begin making what is known as “drug substance” material for the vaccine, a two-month process during which the required biological cells are grown.
The FDA inspected Emergent’s Bayview plant in April 2020, just as the agreement with Johnson & Johnson was being announced. The federal agency criticized Emergent for problems with its testing of a potential treatment for anthrax, according to the records obtained by the AP. The FDA’s lead investigator cited the company for failing to train employees “in the particular operations they perform as part of their function and current good manufacturing practices.”
On the same day, Johnson & Johnson heralded its partnership with Emergent as a step toward the pharmaceutical giant’s goal of supplying more than 1 billion doses of its vaccine globally by the end of 2021.
But the FDA’s inspection of Emergent’s Bayview plant had faulted the company for a series of quality-control shortcomings, according to the records. Although the inspection was not triggered by work on a covid-19 vaccine, the issues listed by agency inspectors stand out because of the large role Emergent would soon have in tackling 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. The FDA’s lead investigator, Marcellinus Dordunoo, wrote that Emergent had not investigated what he described as “data integrity concerns.”
Emergent also did not follow proper testing and lab procedures at Bayview, the FDA said, noting that “deviations from test methods are not investigated, and are manually corrected days after performance, with no supporting data or documented justification.”
The FDA also criticized Emergent 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.”
REMDESIVIR TAB $162M
Separately, a new government report says the United States spent $162 million getting Gilead’s covid-19 drug remdesivir to market but opted against seeking government patents because Gilead invented the experimental medicine years earlier.
The drug sells for $3,120 for a five-day course of treatment for covid 19. It brought in $2.8 billion in revenue for Gilead last year and the company expects to make a similar amount this year.
The Government Accountability Office documented government spending and its role in developing remdesivir — which won full Food and Drug Administration approval last year and is now sold under the brand name Veklury — at the request of Sen. Debbie Stabenow, D-Mich., and Rep. Carolyn Maloney, D-N.Y., chairwoman of the House Committee on Oversight and Reform, after Gilead set its price.
Critics complained the cost was excessive for a pandemic-related drug developed with such a large government role. The accountability office released its findings Wednesday.
Remdesivir was initially invented as a hepatitis C drug a decade ago but was shelved by Gilead. It then was tested again by the Centers for Disease Control and Prevention and the U.S. Army as an antiviral drug against other infectious diseases including Ebola. The drug fizzled against Ebola in a clinical trial in Africa but showed promise against coronaviruses.
The largest share of the $162 million was for clinical trials after the coronavirus outbreak began last year, when the National Institute of Allergy and Infectious Diseases sponsored a nationwide clinical trial, the agency report said.
Remdesivir does not significantly prevent covid-19 deaths, but it has shortened hospital stays to 11 days from 15, according to clinical trial findings.
“Federally supported remdesivir research conducted by [the Centers for Disease Control and Prevention, the Defense Department, the National Institutes of Health], and NIH-funded universities has not resulted in government patent rights, because, according to agency and university officials, federal contributions to the research did not generate new inventions,” the report said.
Information for this article was contributed by Richard Lardner, Jason Dearen, Linda A. Johnson, Matthew Perrone and Zeke Miller of The Associated Press; and by Christopher Rowland of The Washington Post.