After Baltimore plant’s mix-up ruined millions of COVID vaccine doses, U.S. puts Johnson & Johnson in charge of facility

The Biden administration has put Johnson & Johnson in charge of a Baltimore manufacturing plant that ruined 15 million doses of its COVID-19 vaccine and stopped the facility from making another vaccine developed by AstraZeneca.

The extraordinary move by the U.S. Department of Health and Human Services will leave the Emergent BioSolutions facility solely devoted to making the Johnson & Johnson single-dose vaccine and is meant to avoid future mix-ups, according to two senior federal health officials. Johnson & Johnson confirmed the changes, saying it was “assuming full responsibility” for the vaccine made by Emergent.


The New York Times and The Washington Post reported that the change came after Emergent, a manufacturing partner to both AstraZeneca and Johnson & Johnson, accidentally mixed up the ingredients from the two different vaccines, which forced regulators to delay authorization of the plant’s production lines.

Robert Kramer, president and CEO of Emergent, rebutted the notion that his employees mixed up ingredients last week on CNBC, instead explaining “one production run, one batch of product, was determined to be inconsistent with our quality specifications.”


On Sunday, a spokesman for Emergent, Matt Hartwig, said the mistake wasn’t a “result of people haphazardly adding the wrong ingredients to a batch” and that a drug substance may not meet specification because of various reasons, which he did not detail.

“Unfortunately, this sort of thing can happen, especially as you rapidly scale up manufacturing capacity to over a billion doses annually,” Hartwig said in a statement. “The important thing is that our rigorous safety and quality protocols identified the issue, and the batch was put aside.”

Federal officials have said they are worried the mix-up will erode public confidence in the vaccines, just as President Joe Biden is making an aggressive push to have enough vaccine doses to cover every American adult by the end of May. At the same time, there is deep concern about the safety of the AstraZeneca vaccine, amid a health scare that has prompted some European countries to restrict its use. AstraZeneca said in a statement that it would work with the Biden administration to find an alternative site.

The mix-up and the administration’s move to put Johnson & Johnson in charge is a significant setback for Emergent, a Maryland biotech company that has built a profitable business by teaming up with the federal government, primarily by selling its anthrax vaccines to the Strategic National Stockpile.

Experts in vaccine manufacturing said that in the past, the FDA had a rule to prevent such mishaps by not allowing a facility to make two live viral vector vaccines, because of the potential for mix-ups and contamination.

None of the Johnson & Johnson doses made by Emergent have been released by the FDA for distribution. The agency’s acting commissioner, Dr. Janet Woodcock, made clear in a statement that ultimate responsibility for the vaccine production rested with Johnson & Johnson.

“It is important to note that even when companies use contract manufacturing organizations, it is ultimately the responsibility of the company that holds the emergency use authorization to ensure that the quality standards of the FDA are met,” Woodcock said.

Dr. Joshua Sharfstein, vice dean at the Johns Hopkins Bloomberg School of Public Health, said it will be incumbent on the FDA to “get to the bottom of what happened,” including ensuring the facility doesn’t have “major problems,” and to explain its findings to the public. He said he expects the FDA will effectively oversee “a number of fixes.”


“The FDA does a terrific job overseeing vaccine manufacturing, but a lot of that work is hidden from the public,” Sharfstein said. “Greater transparency can improve confidence people have in the process.”

Sharfstein and Dr. Leana Wen, a former Baltimore health commissioner and professor at George Washington University, said people shouldn’t worry about the Johnson & Johnson vaccine.

“Actually, people should be assured that quality control processes are in place and that they are working,” Wen said in an email. “Vaccines will not be released unless they pass very rigorous quality checks.”

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Tinglong Dai, an associate professor at the Johns Hopkins University Carey Business School, said he thinks Johnson & Johnson will come through in the required time frame with the number of doses it was contracted to provide. He’s worried, however, that the company and regulators haven’t explained sufficiently what prompted the mishap.

“The issue here is about public confidence in the production process,” Dai said. “People want to understand what happened ... I actually believe the supply of the Johnson & Johnson vaccine will be on schedule. The issue will be: Will the demand of the Johnson & Johnson vaccine also be on schedule?”

Emergent’s Baltimore facility is one of two facilities that were built with taxpayer support and are federally designated as “Centers for Innovation in Advanced Development and Manufacturing.” Last June, the government paid Emergent $628 million to reserve space there as part of Operation Warp Speed, the Trump administration’s fast-track initiative to develop coronavirus vaccines.


Johnson & Johnson and AstraZeneca both contracted with Emergent to use the space.

Baltimore Sun reporter Alex Mann contributed to this article.