Factory mix-up spoils 15 million doses of J&J COVID vaccine

A sign at the Johnson & Johnson campus on August 26, 2019 in Irvine, California.
Enlarge / A sign at the Johnson & Johnson campus on August 26, 2019 in Irvine, California.

About 15 million doses of Johnson & Johnson’s one-shot COVID-19 vaccine were ruined, and future vaccine shipments will be delayed. This all follows a mix-up at a manufacturing facility in Baltimore, according to multiple media reports.

Johnson & Johnson had partnered with Emergent BioSolutions to manufacture the active ingredient of its vaccine. But according to two US officials who spoke with Politico, workers at the West Baltimore facility mixed up the ingredients in Johnson &Johnson’s vaccine with those for a different coronavirus vaccine. Emergent BioSolutions is also a manufacturing partner of AstraZeneca, according to the New York Times, which first reported the problem.

The mishap with Johnson & Johnson’s vaccine began before the Food and Drug Administration had authorized the facility to produce the vaccine. Now, that authorization has been delayed and shipments are stalled.

In a statement Wednesday, Johnson & Johnson acknowledged the problem, but noted that none of the vaccines in use are affected. The company explained that a “quality control process identified one batch of drug substance that did not meet quality standards at Emergent Biosolutions… This batch was never advanced to the filling and finishing stages of our manufacturing process.” The vaccines currently in use in the US were manufactured in the Netherlands, according to the Times.

In light of the error, the Biden administration has asked Johnson & Johnson to step up oversight of manufacturing at the Emergent BioSolutions facility. But getting the facility up to regulatory standards could take days or weeks, a senior administration official told Politico.

The delay is significant for Johnson & Johnson, which has struggled to ramp up production of its vaccine. The company barely met its pledge to provide 20 million doses by the end of March, Politico notes. Yet, accelerated production by Johnson & Johnson is critical to the Biden administration’s plans to have enough vaccine available by the end of May to immunize every adult in the country. For now, Johnson & Johnson is planning on having 100 million doses delivered by that time.

White House officials are now hedging their projections for vaccine deliveries to states. In a call to governors Tuesday, White House coronavirus coordinator Jeff Zients forecasted shipments of Pfizer and Moderna vaccines, but cautioned that deliveries from Johnson & Johnson could fluctuate.