US Taps Johnson & Johnson to Run Troubled Vaccine Plant

Carla Harmon
April 5, 2021

Emergent's facility was recruited by the federal government in 2020 to produce enough vaccines from both companies for nationwide distribution, although the AstraZeneca vaccine has not yet been approved for use in the U.S. The accidental conflux of the two vaccines' ingredients into the Johnson & Johnson vaccine was discovered after a quality control check.

The New York Times reported that AstraZeneca said in a statement it will work with President Joe Biden's administration to find an alternative site.

"The COVID-19 pandemic has had a profound impact on adolescents, not just with the complications of the disease, but with their education, mental health, and wellbeing", said Paul Stoffels, vice chairman of the executive committee and chief scientific officer at Johnson & Johnson, in a statement Friday. The inspection came just two months before the CDMO snared an eye-popping $628 million deal from the US government to scale up production capacity in hopes of supplying "tens to hundreds of millions" of COVID-19 vaccine doses through 2021.

Johnson & Johnson has vowed to expand staff and oversight at the plant, according to The Washington Post.

Experts in vaccine manufacturing said that in the past, the F.D.A. had a rule to prevent such mishaps by not allowing a plant to make two live viral vector vaccines, because of the potential for mix-ups and contamination.

Johnson & Johnson has admitted to having produced a faulty batch of coronavirus vaccines at an East Baltimore facility, reportedly due to a mix-up of two ingredients that led to the ruining of about 15 million doses. Instead, the batch was disposed of. Federal investigators chalked it up to "human error", The Times reported, while Emergent itself flagged the issue and reached out to the FDA, according to J&J.

The episode shows that Emergent's quality control systems are working, he said. "Through these checks, a single batch of drug substance was identified that did not meet specifications and our rigorous quality standards". "This is a critical part of ensuring quality and safety of vaccine product".

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