J&J Monitors Emergent BioSolutions After Vaccine Production Error

Johnson & Johnson (J&J) said it is closely monitoring day-to-day operations at its COVID-19 vaccine subcontractor Emergent BioSolutions after a production error at the company’s Baltimore, Md., plant contaminated up to 15 million doses.

J&J said it “is providing additional experts in manufacturing, technical operations and quality to be on-site at Emergent to supervise, direct and support all manufacturing” of its vaccine, but said it still expects to make good on its U.S. delivery targets.

In an April 1 press briefing, White House Press Secretary Jen Psaki noted that the production error did not impact doses in U.S. circulation, as the U.S. doses of the J&J vaccine currently come from a production facility in the Netherlands and that the company “has made clear that it expects to deliver 24 million doses in April and that it expects to meet its commitment of 100 million doses by end of May.”

The updated target is one month ahead of J&J’s previous commitment to the U.S. government.

J&J said the contaminated batch, which was slated for delivery to Europe, “was never advanced to the filling-and-finishing stages.” The FDA is investigating the error, which reportedly occurred when workers at the Emergent facility confused ingredients used to produce the AstraZeneca vaccine with those for the J&J vaccine. Both vaccines use adenovirus-based technology, but they rely on different viral vectors.

This is not the first time Emergent has prompted quality concerns at the FDA, which has yet to authorize the Baltimore facility to produce the J&J vaccine. The company has received repeated inspections from the agency in recent years that found various issues, including poor employee training, data integrity problems and other deficiencies, which resulted in several Form 483 reports. Emergent BioSolutions declined to comment on its past manufacturing inspection issues.

In other J&J vaccine news, South Africa announced that it has authorized the vaccine and has ordered 31 million doses, with deliveries of 2.8 million initial doses expected in the second quarter. ― Jason Scott