After ordering Emergent BioSolutions in March to stop producing vaccines for Johnson & Johnson and AstraZeneca, FDA has now ordered J&J to dispose of 60 million doses of its Covid-19 vaccine made at Emergent’s troubled Baltimore plant, Politico writes.
Federal regulators said the order issued Friday is a result of Emergent’s inadvertent contamination if 15 million J&J shots with the active ingredient from the AstraZeneca vaccine in March, after which tens of millions of doses of both company’s vaccine have been in limbo while federal regulators were determining if they are safe to use.
FDA also cleared for use about 10 million doses made at the same facility owned by Emergent BioSolutions including two batches of the J&J jab, but the cleared batches could wind up overseas as part of the Biden’s plan to donate vaccine to countries in need.
The agency has not yet allowed the Baltimore plant to resume vaccine production.
Media reported on Friday that domestic shipments of the J&J vaccine are on hold after distribution stopped several weeks ago due to waning demand, but also due to abovementioned production issues. Meanwhile, there’s no need to throw out the existing doses since FDA extended the shelf life of that vaccine to 4 and 1/2 months.
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