US: Factory Mix-up Ruins Up To 15 Million Johnson & Johnson COVID Vaccine Doses: What We Know
About 15 million doses of the single-shot coronavirus vaccine made by Johnson & Johnson were ruined in a factory error in the United States, The New York Times reported -- a blow to the company's efforts to quickly boost production.
What happened?
Workers at a plant in Baltimore manufacturing two coronavirus vaccines accidentally conflated the ingredients several weeks ago, forcing regulators to delay authorization of the plant¡¯s production lines.? ?
When contacted by AFP, the pharmaceutical giant said it had identified a batch of doses at the plant run by Emergent BioSolutions "that did not meet quality standards" but did not confirm the specific number affected.
How did it happen?
Emergent BioSolutions is the manufacturing partner to both Johnson & Johnson and AstraZeneca, the British-Swedish company whose vaccine has yet to be authorized for use in the United States. Federal officials attributed the mistake to human error.
In less than a year, Emergent hired and trained hundreds of new workers to produce millions of doses of both vaccines that were supposed to be ready by the time that clinical trials showed whether they actually worked. In late February, one or more workers somehow confused a key ingredient for AstraZeneca¡¯s vaccine with Johnson & Johnson¡¯s, raising questions about training and supervision.
Are the doses affected?
There are not any problems with the doses of the Johnson & Johnson vaccine that have already been delivered ¡ª those were produced in the Netherlands, the Times reported. But the tens of millions of the shots set to ship in April were supposed to come from the Baltimore plant.??
The company also said the batch "was never advanced to the filling and finishing stages of our manufacturing process."
"Quality and safety continue to be our top priority," it said.The Times report however signaled that issues with quality control could affect future output, with the Food and Drug Administration expected to investigate. The FDA told AFP it was "aware of the situation" but declined to comment further.
What are the effects of the mix-up?
The mix-up has delayed future shipments of Johnson & Johnson doses in the United States while the Food and Drug Administration investigates what occurred. Johnson & Johnson has moved to strengthen its control over Emergent BioSolutions¡¯ work to avoid additional quality lapses.??
The mistake is a major embarrassment both for Johnson & Johnson, whose one-dose vaccine has been credited with speeding up the national immunization program, and for Emergent, its subcontractor, which has faced fierce criticism for its heavy lobbying for federal contracts.
