Story at a glance:
- Up to 15 million doses got ruined by a human error.
- The human error refers to poorly trained lab workers at a location the FDA did not approve.
Some batches of Johnson & Johnson's COVID-19 vaccines became contaminated because of human error, not an active ingredient.
On Wednesday, The New York Times reported that 15 million doses were ruined because poorly trained workers at the Emergent BioSolutions lab conflated ingredients for the Johnson & Johnson vaccine and AstraZeneca's vaccine in the same Baltimore factory.
None of Johnson & Johnson's current vaccine patients were affected by the bad batches. The manufacturing error has contaminated 15 million doses of Johnson & Johnson future vaccines, spoiling some people's chances. The mix-up has delayed future shipments of the vaccine while the matter is investigated.
In response to the mix-up, Johnson & Johnson is working with the federal government to prevent further mess-up of its vaccines by hiring people to oversee Emergent's operations.
According to The Associated Press (AP), the site's location has cracked vials and mold around one of its facilities.
The drugmaker said it is committed to making 80 million more doses by the end of May and 100 million doses by the end of June. So far, Johnson & Johnson had made around 6.8 million doses, according to an online vaccine tracker from the Centers for Disease Control and Prevention (CDC), The Guardian reported.
On Thursday, federal health officials said additional 11 million doses are on their way. It is not clear where these doses are coming from, but there is some speculation from a Netherlands factory shipped to the U.S., according to The Guardian.
However, it is unknown how many doses of vaccines were erroneously made. Since 2017, AP reported that Emergent facilities faced issues from its last Food and Drug Administration (FDA) inspection.
The FDA also criticized its Bayview plant in April 2020 for failing to test for anthrax, with its lead investigator saying Emergent is failing to train employees "in the particular operations they perform as part of their function and current good manufacturing practices."
A federal official said Wednesday evening the administration’s goal can be met without additional Johnson & Johnson doses.
As of Wednesday, Johnson & Johnson has provided about 6.8 million doses, according to the Centers for Disease Control and Prevention’s vaccine tracker. Some additional doses may not yet have been recorded as delivered. Federal health officials an additional 11 million doses will be available for shipments starting Thursday.
Johnson & Johnson said it was putting more of its manufacturing and quality experts inside Emergent’s Baltimore factory to oversee production of the vaccine to speed up delivery of an additional 24 million doses through April.
The Johnson & Johnson vaccine has been viewed as crucial for vaccination campaigns around the world, because only one shot is required and it can be shipped and stored at standard refrigeration temperatures. The company also has pledged to sell the vaccine without a profit, but only during the pandemic emergency.
Johnson & Johnson said it still expects to deliver more than 1 billion doses by the end of this year.
The problem with the vaccine batch was first reported by The New York Times. The FDA said it was aware of the situation but declined further comment.
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