Video source: YouTube, WJZ
The US Food and Drug Administration (FDA) is allowing Emergent BioSolutions Inc (NYSE: EBS ) to resume production of Johnson & Johnson's (NYSE: JNJ ) COVID-19 vaccine at the Baltimore facility that was shut down earlier this year due to contamination concerns.
After subsequent inspections revealed problems with cross contamination and mismanagement, the FDA worked with Emergent to address quality control issues and develop an action plan.
In a press release Thursday, Emergent’s chief executive officer Robert Kramer said the resumption follows additional reviews and collaboration with the FDA and manufacturing partners.
“The American people should have high expectations of the partners its government chooses to help prepare them for disaster, and we have even higher expectations of ourselves," Kramer said. "We have fallen short of those lofty ambitions over the past few months but resumption of manufacturing is a key milestone and we are grateful for the opportunity to help bring this global pandemic to an end.”
An FDA spokesperson said the agency “was not opposed” to the facility restarting production of J&J’s COVID-19 vaccine after conducting a limited investigation there earlier this week.
“The vaccine substance being manufactured at this plant will not be distributed until the FDA confirms the plant’s conditions meet the FDA’s rigorous standards for safety, effectiveness and manufacturing quality,” the spokesperson said in a statement to The Baltimore Sun.
Despite the factory’s history of FDA citations for problems such as mold, poorly trained employees and inadequate strategies to prevent contamination, Emergent was handed a $628 million contract last year by the Trump administration to produce millions of COVID-19 vaccines for J&J and AstraZeneca.
Emergent is one of several companies contracted by J&J to produce the one-shot vaccine in bulk, according to The Associated Press.
The shutdown forced J&J to import millions of doses from its factory in the Netherlands and to miss supply commitments.
Last week, J&J slashed its 2021 production goal of its single-dose COVID-19 vaccine from one billion to between 500 million and 600 million shots.
Emergent’s factory could make as many as 120 million doses per month at full capacity, but the finished doses might not be available until the fall, The Wall Street Journal reported.
The Biden administration has been working to find a different American manufacturing partner for British drugmaker AstraZeneca, whose COVID-19 vaccine is not currently authorized for use in the US.
Source: Equities News