How Layered Process Audits Could Have Saved 15 Million J&J Vaccines

Ease Insider

April 1, 2021

How Layered Process Audits Could Have Saved 15 Million J&J Vaccines

Just days before FDA authorization, the Johnson & Johnson coronavirus vaccine suffered an unfortunate blow as 15 million life-saving doses were compromised.

The news comes as a potentially severe setback for the U.S.’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’ve 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 Plc. for a different version of the coronavirus vaccine.

Last week, employees at Emergent’s Bayview, Baltimore plant made egregious errors when ingredients for the two different vaccines were combined, which rendered 15 million of the J&J vaccine doses unusable. The lack of separation in processes for manufacturing the two vaccines played a big factor in the mistake, as did insufficient training for the workers at this facility.

This specific plant has a worrisome record of citations from U.S. health officials over quality and safety control. Add in lack of readiness to scale to developing millions of vaccines at this time last year when first contracted by J&J, and there were plenty of warnings for this bleak outcome.

The Consequences

The Johnson & Johnson vaccine boasts that individuals only need a single dose of the coronavirus vaccine as opposed to Pfizer and Moderna’s 2 doses, which meant that J&J vaccine vials could go a longer way in President Biden’s plan to have enough vaccines for every U.S. 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 financial and reputational implications for both Johnson & Johnson and Emergent. For any who already had concerns about the speed at which the coronavirus vaccine was developed, at minimum there may be skepticism about the quality and safety supervision in place. Additionally, the Emergent facility where the incident took place was temporarily shut down on April 19 pending the results of an FDA inspection. 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 always 20/20, 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 verification of the plant’s manufacturing processes, would have caught the mistake before it affected 15 million doses of the vaccine.

For a project affecting 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 defined 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 efforts put in place to determine when and how the problem was fixed.

Note: This post was updated on May 6, 2021 to reflect the temporary shutdown of the Emergent Biosolutions facility in Baltimore.