A new congressional report concluded that Emergent BioSolutions (NYSE:EBS) attempted to hide evidence related to quality problems before informing the FDA that 15 million COVID-19 vaccines were contaminated. Prepared for Rep. Carolyn Maloney (D-NY) and James E. Clyburn (D-SC), the report from the House and the Select Subcommittee on the Coronavirus Crisis scrutinizes the quality controls in…
U.S. cancels COVID-19 vaccine contract with Emergent BioSolutions
Emergent BioSolutions (NYSE:EBS) saw its stock plunge today after the U.S. nixed a contract to manufacture COVID-19 vaccine doses for Johnson & Johnson (NYSE:JNJ). Earlier this year, the company disposed of tens of millions of COVID-19 vaccine doses after identifying a manufacturing error in a Baltimore plant. FDA released a scathing inspection report related to…
FDA OKs AstraZeneca’s Emergent-produced vaccine for export
After facing months of setbacks concerning its contract production of COVID-19 vaccine, Emergent BioSolutions (NYSE:EBS) is making progress. Most recently, the FDA announced that “certain lots” of AstraZeneca (LON:AZN) COVID-19 vaccine drug substance produced in a facility in Baltimore are acceptable for export. Last week, the FDA gave the company permission to restart Johnson &…
Emergent BioSolutions facing a shareholder lawsuits
The Baltimore-based company Emergent BioSolutions (NYSE:EBS) is the subject of at least four lawsuits asking for refunds and pushing for change in the company’s executive ranks. Some of the lawsuits targeting Emergent accuse the company of securities fraud and insider trading. Emergent has denied the allegations. “Our executives strictly follow the law and our own…
J&J must reportedly throw out 60M COVID-19 vaccine doses from Emergent plant
Another large amount of doses of Johnson & Johnson’s COVID-19 vaccine produced at an embattled manufacturing plant reportedly have to be thrown out. The New York Times reported that the FDA told J&J that about 60 million doses of the single-dose vaccine produced at Emergent BioSolutions’ Baltimore plant can’t be used because of possible contamination.…
FDA releases scathing inspection report regarding Emergent BioSolutions plant
An FDA report cites multiple failures in an Emergent BioSolutions plant tapped to produce vaccines for Johnson & Johnson and AstraZeneca. The vaccine plant had been forced to discard up to 15 million doses of Johnson & Johnson’s COVID-19 vaccine in a single manufacturing batch. Emergent BioSolutions recently paused production of the vaccine during the FDA inspection and…
Johnson & Johnson COVID-19 vaccine shipments plunge
Johnson & Johnson will cut COVID-19 vaccine shipments by 86% in the coming week, according to CDC projections. The week of April 5, the company shipped nearly 5 million doses. Next week, that figure could fall to approximately 700,000. The company anticipates that it can eventually deliver up to 8 million doses weekly, assuming FDA authorizes…
Emergent reportedly had serious problems at Baltimore vaccine plant
Emergent BioSolutions was not prepared to take on the mammoth task of churning out millions of COVID-19 vaccine doses to support U.S. efforts to end the pandemic, according to a report published today in The New York Times. Emergent was ill-equipped despite a $163 million federal contract to prepare the facility for high-volume production, according…
Feds put J&J in charge of vaccine production at Emergent plant
Johnson & Johnson (NYSE:JNJ) announced that it assumed full responsibility for the production of its COVID-19 vaccine at the Emergent BioSolutions Bayview (Baltimore) facility. The company’s announcement comes days after news broke that a factory error made at that facility resulted in 15 million discarded COVID-19 vaccines. New Brunswick, N.J.–based J&J’s single-dose vaccine was authorized…
Factory error ruins 15M J&J COVID-19 vaccine doses
Employees at an Emergent BioSolutions (NYSE:EBS) facility in Baltimore made a mistake several weeks ago when formulating the ingredients for Johnson & Johnson’s COVID-19 vaccine, requiring 15 million doses of it to be discarded. A quality control process revealed that one batch of a drug substance for the J&J COVID-19 vaccine “did not meet quality…