INDUSTRY FOCUS Pharmaceuticals

How layered process audits could have saved 15 million J&J vaccines

By Eric Stoop, CEO of Ease, Inc.

ust days before FDA authorisation, the Johnson & Johnson (J&J) coronavirus vaccine suff ered an unfortunate blow as 15 million life- saving doses were compromised. The news came as a potentially severe setback for the US’s plan to have enough vaccines for every American by the end of May 2021.


So, what happened at the contract manufacturer that led to millions of J&J vaccines going to waste, and what are the consequences? More importantly, what could have been done to prevent this?

How did this happen? Emergent Biosolutions is the manufacturer contracted by Johnson & Johnson in April 2020 to develop the biological cells to create the drug substance for its one-shot vaccine. Emergent Biosolutions was also contracted by AstraZeneca for a diff erent version of the coronavirus vaccine. In April, employees at Emergent’s Bayview, Baltimore, plant made egregious errors when ingredients for the two diff erent vaccines were combined, which rendered 15 million of the J&J vaccine doses unusable. The lack of separation in the processes for manufacturing the two vaccines played a big factor in the mistake, as did insuffi cient training for the workers at this facility. This specifi c plant has a worrisome

record of citations from US health offi cials over quality and safety control. Add in lack of readiness to scale to developing millions of vaccines at this time last year when fi rst contracted by J&J, and there were plenty of warnings for this bleak outcome.


The Johnson & Johnson vaccine boasts that individuals only need a single dose of the coronavirus vaccine as opposed to Pfi zer

32 June 2021 | Automation

and Moderna’s two doses, which meant that J&J vaccine vials could go a longer way in President Biden’s plan to have enough vaccines for every US adult by this summer. With 15 million doses discarded as waste, this setback leaves an equal number of Americans potentially at risk of infection. This error will also have fi nancial and

reputational implications for both Johnson & Johnson and Emergent. For those who already had concerns about the speed at which the coronavirus vaccine was developed, at minimum there may be scepticism about the quality and safety supervision in place. Reportedly there are still plans for 100 million J&J vaccines by the end of May, but who knows how this setback will actually impact that outcome.

Was prevention possible? Hindsight is a wonderful thing, but the answer is a resounding yes. Even when there isn’t a huge demand and pressure to save lives, standard operating procedures are simply not enough.

Regular checks on not only the product or output, but also verifi cation of the plant’s manufacturing processes, would have

caught the mistake before it aff ected 15 million vaccine doses. For a project aff ecting so many lives, digital layered process audits (LPAs) should have been in place to verify that the right procedure was being followed. Just as important, digital LPAs would have helped ensure that any non-compliant inputs were mitigated before they resulted in ruined product. A robust LPA program would have involved all levels of management responsible for vaccine quality at the facility by auditing their processes – every shift, every day – to ensure that protocols were followed correctly. Using a defi ned set of questions would have enabled quality management to quickly identify which steps in the process were non-compliant. Managing this process digitally, they could also track the mitigation eff orts put in place to determine when and how the problem was fi xed.


Ease, Inc.

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