[Asia Economy Reporter Cho Hyun-ui] It has been revealed that there was a high possibility that vaccine manufacturing materials and waste were mixed at the Baltimore factory in the United States, where an incident occurred involving the mixing of COVID-19 vaccine components from AstraZeneca (AZ) and Janssen, the pharmaceutical subsidiary of Johnson & Johnson (J&J).
According to major foreign media on the 21st (local time), the U.S. Food and Drug Administration (FDA) conducted an inspection of the 'Emergent BioSolutions' factory from the 12th to the 20th. The FDA requested a production halt last month after an incident occurred at this factory where vaccine components were mistakenly mixed.
The FDA reviewed security camera footage installed in the factory and visited the site to inspect the facilities directly. As a result, several issues were found, including dirty production facilities, untrained personnel, and potential mixing risks.
According to the FDA investigation report, workers sometimes bumped into containers holding vaccine manufacturing materials while moving unsealed medical waste.
To move between rooms storing different materials, workers were required to pass through a shower room, but one worker was found to have used it only once in 19 days.
The FDA pointed out, "Especially because the manufacturing facility is cramped, workers often bumped into each other while carrying containers holding vaccine manufacturing materials." Paint stains were observed in hallways where glass vials for vaccines were stored, and several cases of cracked containers were also detected.
The FDA also confirmed the mixing incident of AZ and Janssen vaccines. The factory reportedly did not provide training to personnel to avoid mixing Janssen and AZ vaccine materials.
Experts predict, "It may take several months for the factory to correct the issues pointed out by the FDA."
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