Mix-up by company making J&J COVID-19 vaccine delays shipment

Emergent BioSolutions
Posted at 4:26 PM, Mar 31, 2021

A company making Johnson & Johnson’s one-shot coronavirus vaccine accidentally ruined 15 million doses of the vaccine, according to a New York Times report on Wednesday.

The company, Emergent BioSolutions based in Baltimore, was brought on to speed the process of manufacturing the vaccine. Emergent BioSolutions has been tasked with producing vaccines for both Johnson & Johnson and AstraZeneca. The AstraZeneca vaccine has yet to receive FDA emergency use authorization.

According to the New York Times report, Emergent BioSolutions accidentally conflated the vaccines’ ingredients several weeks ago. The mix-up forced regulators to delay authorizing the plant’s production line.

In a statement, Johnson & Johnson downplayed the effect that the mix-up had on delaying shipments of its coronavirus vaccine.

“As with the manufacturing of any complex biologic medication or vaccine, the start-up for a new process includes test runs and quality checks to ensure manufacturing is validated and the end product meets our high-quality standards,” Johnson & Johnson said in a statement. “This approach includes having dedicated specialists on the ground at the companies that are part of our global manufacturing network to support safety and quality.”

“This quality control process identified one batch of drug substance that did not meet quality standards at Emergent Biosolutions, a site not yet authorized to manufacture drug substance for our COVID-19 vaccine,” Johnson & Johnson added. “This batch was never advanced to the filling and finishing stages of our manufacturing process. This is an example of the rigorous quality control applied to each batch of drug substance. The issue was identified and addressed with Emergent and shared with the United States Food & Drug Administration.”

Johnson & Johnson said that it met a goal of delivering 20 million COVID-19 vaccines by the end of March, and says it is on track to deliver 100 million vaccines by the end of May.

Unlike the Pfizer and Moderna vaccines, which garnered emergency use authorization in December, the Johnson & Johnson vaccine comes in one dose.

Initial results released by Johnson & Johnson last month indicated that the vaccine reduced severe instances of the disease by 85 percent, and no person who took the vaccine died as a result.

The findings also found that the vaccine was 66% effective in completely preventing the disease. The two other vaccines that have been approved for emergency use both showed to be more than 90% effective in preventing all cases of the disease.