Workers at a Baltimore plant making two coronavirus vaccines accidentally confused the ingredients of the vaccines several weeks ago, ruining an estimated 15 million doses of Johnson & Johnson vaccine and forcing regulators to delay clearance of the vaccine lines. factory production.
The factory is run by Emerging BioSolutions, manufacturing partner of Johnson & Johnson and AstraZeneca. Federal officials attributed the error to human error.
The confusion has halted future shipments of Johnson & Johnson doses to the United States while the Food and Drug Administration investigates. Johnson & Johnson has decided to strengthen its control over the work of Emerging BioSolutions in order to avoid further quality failures.
The mistake is a major embarrassment for Johnson & Johnson, whose single-dose vaccine has been credited with speeding up the national immunization program.
It does not affect the doses of Johnson & Johnson currently dispensed and used nationwide. All of these doses were produced in the Netherlands, where operations have been fully approved by federal regulators.
But all other shipments of the Johnson & Johnson vaccine – which are expected to total tens of millions of doses next month – were to come from the massive Baltimore plant.
These shipments are now being challenged as quality control issues are addressed, according to people familiar with the matter.
Federal officials still expect to have enough doses to meet President Biden’s pledge to provide enough vaccines by the end of May to immunize every adult. The other two federally approved manufacturers, Pfizer-BioNTech and Moderna, continue to deliver as planned.
Pfizer is shipping its doses ahead of schedule, and Moderna is close to getting approval to deliver vaccine vials of up to 15 doses instead of 10, further increasing the country’s stockpile.