The company at the Center for Quality Issues that caused Johnson & Johnson to discard an unknown quantity of coronavirus vaccines has been cited in a series of quality control issues by US health officials.
Emergent BioSolutons, a little-known company in the center of the vaccine supply chain, is key to Johnson & Johnson’s plan to deliver 100 million doses of vaccine to the United States by the end of May. However, according to records obtained by the Associated Press through the Freedom of Information Act, the company was repeatedly cited by the Food and Drug Administration for issues such as insufficient staff training, broken vials, and mold in one of the facilities. The records cover inspections of emergency facilities since 201
Johnson & Johnson said on Wednesday that it cannot use a batch of vaccines produced by Emergent at its Baltimore plant Bayview due to the emergency situation that does not meet quality standards. It is unclear exactly how many doses are involved or how this issue will affect the future delivery of Johnson & Johnson vaccine. The company said in a statement that it still plans to deliver 100 million doses by the end of June and “plans to deliver these doses by the end of May.”
Johnson & Johnson reached a partnership with Emergent in April 2020, inviting little-known companies to produce vaccines that Johnson & Johnson is developing under federal funding. According to the FDA’s records, the factory was a contract testing laboratory at the time and “had no products for distribution.” According to records at the time, Emergent’s Bayview facility had not yet expanded the production of millions of doses of potential COVID-19 vaccine. Before Bayview can start manufacturing the so-called “drug” materials for vaccines, it needs technical and personnel upgrades. This is a two-month process during which the required biological cells will grow.
The FDA inspected Emergent’s Bayview plant in April 2020, just as it announced an agreement with Johnson & Johnson. According to records obtained by the Associated Press, federal agencies criticized the company for having problems testing potential treatments for anthrax. The FDA’s chief investigator pointed out that the company failed to train its employees on specific operations performed in its functions and current good manufacturing practices.
On the same day, Johnson & Johnson announced a partnership with Emergent in another press release, which is a step towards the pharmaceutical giant’s goal of providing more than 1 billion doses of vaccines globally by the end of 2021.
Other issues mentioned by the FDA in the April 2020 inspection include the failure of the Bayview factory, “to ensure that the electronically stored data generated during analysis and testing of materials” is protected and cannot be deleted or manipulated.” FDA chief researcher Marcellinus Dordunoo wrote Dao, Emergent has not investigated what he referred to as “data integrity issues.”
The inspection is the latest in a series of important FDA reports on Emergent, including the latest report after an inspection conducted at a plant in Canton, Massachusetts in December 2017, in which the FDA stated that the company has not corrected the “continuous low Yeasts were found in horizontal molds and facilities. About a year later, the investigators of the agency questioned why in another Baltimore factory called Camden, Emergent formulated an “unwritten policy not to conduct routine compliance audits” and filled the vials in the factory. Anthrax vaccine.
During the Trump administration, emergency revenue surged from approximately US$523 million in 2015 to more than US$1.5 billion in 2020. According to the disclosed record, the company invested a lot of money in lobbying the federal government, which shows that the company spent $3.6 million in lobbying alone in 2020.
The company said Emergent is one of about 10 companies Johnson & Johnson uses to accelerate the production of its recently approved vaccine. The Bayview factory where the contaminated vaccine components were found has not yet been approved by the FDA, so it will not affect the vaccine in circulation. The emergency declined to comment.
President Joe Biden has promised to provide all American adults with enough vaccines by the end of May. The U.S. government has ordered Pfizer and Moderna to inject enough two doses of vaccine to provide 200 million people with the vaccine by late May, and Johnson & Johnson’s 100 million single doses.
A federal official said Wednesday night that the government’s goals can be achieved without J&J taking J&S.
A Johnson & Johnson spokesperson said earlier Wednesday that the company had reached its goal at the end of March, and the Centers for Disease Control and Prevention’s online vaccine tracking system showed that Johnson & Johnson had provided approximately 6.8 million doses for the US vaccine work. Johnson & Johnson has shipped finished vaccines from its plant in the Netherlands to the United States.
Johnson & Johnson said it will put more manufacturing and quality experts into Emergent’s factories to oversee the production of the COVID-19 vaccine. This move aims to deliver another 24 million doses of vaccine by April.
Johnson & Johnson said it still hopes to provide more than 1 billion doses of vaccines worldwide by the end of this year.
Johnson & Johnson vaccine is considered to be vital to vaccination campaigns around the world because it only requires a single shot to be transported and stored at standard refrigeration temperatures, which is different from other vials that must be frozen. The company also promised to sell the vaccine only during pandemic emergencies without profit.
The issue of vaccine batches was first reported by the New York Times. The FDA said it had understood the situation, but declined to comment further.
Johnson is from Fairless Hills, Pennsylvania, and Washington is from Lardner. Associated Press writers Matt Perrone and Zeke Miller in Washington and Jason Dearen in New York contributed to this report.
Please contact AP’s global investigation team at Investigative@ap.org. Follow Richard Lardber on Twitter with @RPLardner.
The Associated Press Department of Health and Science is supported by the Department of Science Education at the Howard Hughes Medical Institute. AP is solely responsible for all content.