Emergent told to halt manufacturing while FDA inspects its COVID-19 vaccine facility

20-Apr-2021 - Last updated on 20-Apr-2021 at 12:27 GMT

Emergent BioSolutions, a contract development and manufacturing organization (CDMO), has agreed with the US FDA not to manufacture any new COVID-19 vaccine materials at its Bayview facility in Baltimore, Maryland, while the regulator investigates the plant.

The company said the US Food and Drug Administration (FDA) began an inspection of the Baltimore site on April 12 and asked it to pause manufacturing four days later, pending completion of the review and remediation.

In a filing to the US Securities and Exchange Commission (SEC), the CDMO also announced that it has quarantined all existing material manufactured at the facility.

Ingredient mix-up

A production issue at Emergent’s Baltimore plant late last month saw a massive batch of Johnson & Johnson’s COVID-19 vaccine doses spoiled. The CDMO had been producing both the J&J and AstraZeneca vaccines, but mixed up ingredients from the two, causing the loss of 15 million doses, according to a report in the New York Times.

As a result, the Biden administration, thereafter, put Johnson & Johnson (J&J) in charge of Emergent’s facility and it moved to stop the plant from making the AstraZeneca vaccine.

A White House media briefing, at that time, noted “with assistance from the Health and Human Services (HHS) Department, Johnson & Johnson has taken complete control of the plant. They are going to make the Johnson & Johnson vaccine the only vaccine made in this plant to eliminate the potential for any cross-contamination. This was a decision that HHS made with Johnson & Johnson and AstraZeneca in complete collaboration, and so AstraZeneca also agreed that this was the right course.”

The suspension in the production of new materials is yet another challenge for Johnson & Johnson in the roll out of its COVID-19 vaccine in the US. Last week, the FDA and the US Centers for Disease Control and Prevention (CDC) advised US states to temporarily halt using J&J’s vaccine “out of an abundance of caution” after six women developed a rare but potentially life-threatening blood clotting disorder that resulted in one fatality, and another individual still in critical condition.

In a statement on April 14, Johnson & Johnson said: “We continue to believe in the positive benefit-risk profile of our vaccine. We will continue to collaborate with medical experts and global health authorities, including the CDC, US Food and Drug Administration (FDA), European Medicines Agency and the World Health Organization, as we work toward continuing vaccinations to end the global pandemic.”