Ingredient Mix Up Ruins 15 Million Doses of J&J Vaccine

BioPharm International Editors

Human error at an Emergent BioSolutions facility cited as cause for the loss of a large batch of COVID-19 vaccines.

A manufacturing error at an Emergent BioSolutions contract manufacturing facility has reportedly ruined up to 15 million doses of Johnson & Johnson’s (J&J’s) COVID-19 vaccine, according to a New York Times report on March 31, 2021 citing unnamed federal officials. The report stated that in February 2021, workers accidentally mixed ingredients for the J&J vaccine with another vaccine manufactured at the facility.

J&J reported in a March 31, 2021 press statement that a batch of drug substance for the company’s vaccine produced at the Emergent facility in Maryland did not meet company’s quality standards and was rejected prior to the fill/finish stage.

J&J said the company has addressed the quality issue with Emergent and shared the information with FDA. Emergent’s Bayview facility, which also produces vaccine drug substance for AstraZeneca, is not yet authorized by FDA to manufacture the J&J vaccine drug substance.

In the statement, J&J said “rigorous quality control” practices, which included test runs and quality checks, were employed to ensure the manufacturing process was validated and product standards are met for each batch of drug substance. Quality specialists from J&J are on site at the Emergent facility to support safety and quality, the company reports.

“Quality and safety continue to be our top priority,” the J&J reported in the statement. “Therefore, as we continue to work with FDA and Emergent toward the Emergency Use Authorization of the Emergent Bayview Facility, Johnson & Johnson is providing additional experts in manufacturing, technical operations and quality to be on-site at Emergent to supervise, direct, and support all manufacturing of the Johnson & Johnson COVID-19 vaccine.”

J&J also noted that the company delivered, as committed, 20 million single-shot vaccines by the end of March 2020 for the US market and plans to distribute an additional 24 million single-shot vaccine doses through April. The company also plans to deliver 100 million single-shot vaccines to the United States by the end of May.

Sources: Johnson & Johnson and New York Times