The FDA has just made J & J tokens of 60 million doses.
After a vaccine plant was clogged, Johnson & Johnson must destroy millions of doses.
The Johnson & Johnson Covid Vaccine, notable for its regeneration at a dose, experienced a handful of trials and tribulations in recent months. The vaccine was briefly paused by the Food and Drug Administration (FDA) due to its link toblood clots, then brought back to traffic. Now,The New York TimesReports that the FDA requires Johnson & Johnson to throw 60 million doses of its Covid vaccine. The millions of doses will be destroyed due to possible contamination to the plant they have been produced in Baltimore, managed by emerging biosolutions.
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The problems with the plant began in April - it was closed after an inspection identified a handful of violations and has not reopened yet. One of the most problematic violations was theContamination Johnson & Johnson vaccines with an ingredient of the Covid vaccine of Astrazeneca,The New York Times reported. While approximately 170 million doses of the two vaccines were in question following the inspection, Johnson & Johnson should only close a fraction of them. The FDA told CNBC thatseveral lots were not "suitable for use".
On June 11, the FDA released a statement indicating that before making the decision, it "conducted in-depth criticism Records of the installation and the results of the quality tests carried out by the manufacturer. "Taking into account the ongoing global health crisis and the results of the review, the FDA has decided that some lots of Johnson & Johnson were recoverable. The agency stated that it pursued" work through problems "At the emerging plant of biosolutions.
According toThe New York TimesThe FDA plans to leave about 10 million doses being distributed to the US state or sent abroad with the stipulation that the Agency can not guarantee that emerging biosolutions have followed good manufacturing practices while producing the vaccine. The doses of Johnson & Johnson who are already in arms in the United States have been produced in a factory in the Netherlands. They were not affected by this possible contamination.
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After the inspection, the officials declared that emerging biosolutions can no longer produceAstazeneca vaccine and instructed Johnson & Johnson to directly control the manufacture of its vaccines at the factory, byThe New York Times.Peter's brands, PhD, the FDA vaccine regulator, stated in the statement that "the examination took place while emerging biosolutions prepare to resume manufacturing operations with corrective actions to ensure compliance with the good. Current manufacturing requirements of the FDA ".
While the United States has many Pfizer and modern vaccines to distribute, lose 60 million doses of Johnson & Johnson poses a problem for the presidentJoe Biden's plan to send vaccines abroad.The New York Times Reports that the administration planned to share doses of Johnson & Johnson vaccines and AstraZeneca Covid, but this plan was delayed in the middle of the FDA revision of emerging biosolutions facilities.
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