(FiveNation.com)- The federal government canceled a multi-million-dollar deal with a Baltimore vaccine manufacturer after it was discovered that millions of doses of the Johnson & Johnson vaccine were contaminated during production.
In March, a factory mix-up at Emergent BioSolutions resulted in a batch of the active substance used in the one-shot vaccine getting contaminated with materials from another vaccine also manufactured at the Bayview plant. The mix-up delayed shipments of the Johnson & Johnson vaccine while the FDA investigated the incident.
In mid-June, the European Union’s drug regulator announced that it will not use any batches of the Johnson & Johnson vaccine made at Emergent BioSolutions. In suspending its contract, the European Medicines Agency assured the public that none of the vaccines the EU obtained from Emergent BioSolutions were affected by this contamination. However, “as a precaution and to safeguard the quality of vaccines,” the EU would suspend the use of any J & J doses made at around the same time the contamination occurred.
Up to sixty million doses of the Johnson & Johnson one-dose vaccine had to be thrown out due to possible contamination.
After the mix-up was discovered, Emergent BioSolutions determined the contamination was caused by “human error.” That human error resulted in millions of doses being ruined and forced regulators to delay the authorization of the plant’s production lines.
News of the contract’s cancelation came during a Thursday conference call with the vaccine manufacturer. In discussing its latest financial earnings, Emergent disclosed that it will forgo about $180 million due to the federal government terminating its contract.
Emergent BioSolutions played a role in the Trump administration’s Operation Warp Speed.
After the contamination, the Biden administration placed direct control of vaccine production on Johnson & Johnson.
The problems at the Bayview factory in Baltimore hobbled Johnson & Johnson’s ability to be a major player in the COVID vaccination push — especially in remote areas and poor countries.
Emergent BioSolutions has been repeatedly cited by the FDA for problems such as poorly trained employees, cracked vials, and problems managing mold and other contamination around one of its facilities.
In addition to bulk manufacturing the Johnson & Johnson vaccine, Emergent BioSolutions also manufactures doses of the AstraZeneca vaccine.
The FDA has assured that none of the contaminated doses were ever distributed to the public.