"Accidental Mixing of Other Company's Vaccine Ingredients"... FDA Launches Investigation
Production of 100 Million Doses by End of June Becomes Difficult... US Vaccine Supply Impacted

[Image source=Yonhap News]

[Image source=Yonhap News]

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[Asia Economy Reporter Hyunwoo Lee] It has been reported that 15 million doses of Johnson & Johnson (J&J) COVID-19 vaccine were completely discarded after vaccine components from another company were accidentally mixed at a subcontracted factory manufacturing J&J's vaccine components. The J&J vaccine, which requires only a single dose, had been expected to significantly increase vaccination rates in the future, but the major disruption in production has put the U.S. government's vaccine supply under emergency.


According to the New York Times (NYT) on the 31st (local time), at the Baltimore factory of Emergent BioSolutions, a partner company manufacturing vaccine components for both J&J and AstraZeneca, vaccine components from the two pharmaceutical companies were accidentally mixed, resulting in the disposal of 15 million doses of J&J vaccine. J&J stated in a press release that day, "During quality control procedures, it was discovered that the content of some pharmaceutical substances fell below quality standards," and accordingly, "the final stage of the manufacturing process was not properly conducted."


The U.S. Food and Drug Administration (FDA) has suspended approval for the vaccine quantities produced on this factory's production line and has launched an investigation into the incident. Distribution of the J&J vaccine will be halted until the investigation is completed and health authorities finish their safety review. However, the NYT reported that the J&J vaccines already distributed and used nationwide were produced in the Netherlands and are unrelated to this incident. The vaccines produced at the Baltimore factory were scheduled to be supplied starting in April.



Previously, the COVID-19 vaccine developed by J&J's subsidiary Janssen had been operating its production lines at full capacity since the U.S. Centers for Disease Control and Prevention (CDC) gave final approval on the 28th of last month. Unlike other vaccines, the J&J vaccine requires only one dose and does not need to be stored frozen, which had raised expectations for significantly accelerating vaccination speed. However, due to an unexpected error in the production process, the entire U.S. government vaccine distribution program has been disrupted. J&J had planned to supply 20 million doses by the first quarter and 100 million doses by the second quarter of this year.


This content was produced with the assistance of AI translation services.

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