Johnson & Johnson COVID vaccine allotment will be ‘relatively low’ until Baltimore plant that ruined doses gets FDA approval

Maryland health officials expect to see a drastic reduction in the state’s allocation of Johnson & Johnson’s COVID-19 vaccine next week — a shortfall that will lead to a 33% drop overall in the availability of first- or single-dose vaccines compared to this week, officials said.

The state will have 78,000 fewer than expected doses of Johnson & Johnson’s single-dose vaccine next week, Maryland Health Department spokesman Charles Gischlar said Thursday.

“Please keep in mind that the vaccines are federal assets and the federal government controls our vaccine supply,” state Health Secretary Dennis R. Schrader said Thursday in a letter to vaccine providers. “This significant decrease with no advance notice is a surprise and a disappointment, and we share your frustration.”

The department declined to comment on the reason for the reduction. It comes after a grave error made at an East Baltimore facility tasked with producing Johnson & Johnson and other COVID-19 vaccines, resulting in millions of doses going to waste.

The site of the ruined doses, the Emergent BioSolutions plant near the Johns Hopkins Bayview Medical Center, does not yet have approval from the U.S. Food and Drug Administration to distribute its product, and officials have said all the Johnson & Johnson vaccine distributed in Maryland is made in Europe.

But an official with the U.S. Department of Health and Human Services told The Baltimore Sun Thursday that Johnson & Johnson expects to provide “a relatively low level of weekly dose delivery” until the East Baltimore plant gets federal authorization to distribute.

The vaccine maker still expects to fulfill its 100 million-dose commitment to the U.S. around the end of May, the official said.

Gaithersburg-based Emergent BioSolutions, a crucial cog in the global vaccine manufacturing network, has received hundreds of millions in federal dollars to boost production of COVID-19 therapies and vaccines, including at its East Baltimore factory. Johnson & Johnson said in a statement that a 15-million dose batch of urgently needed COVID-19 vaccine had to be destroyed because it did not meet the company’s quality standards.

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Emergent BioSolutions' Bayview has a contract to bulk produce four COVID vaccines that are not yet authorized but waiting in the wings, including one from Johnson and Johnson that appears close. The Bayview plant was built with government money for just such a pandemic need. (Jerry Jackson/Baltimore Sun)

Johnson & Johnson has assumed control of the plant, and vaccine maker AstraZeneca has stopped its production line there.

Records obtained by The Baltimore Sun through a public records request show numerous problems inside the Bayview facility dating back to at least a year ago, including “deficient” areas to prevent contamination or mixup of rejected components; insufficient employee training in manufacturing; a lack of standardization of quality-control measures; and a non-adherence to test procedures and laboratory control mechanisms.

Johnson & Johnson also has a contract with the European Union, for 200 million doses. . The company is expected to deliver as many as 50 million doses to Europe by the end of the second quarter of 2021.

All doses distributed in the United States so far have been shipped from Europe.

Tinglong Dai, an associate professor at the Johns Hopkins University Carey Business School who studies vaccines, said the East Baltimore mishap is likely to cause some short-term shipment delays. Beyond the bad batch, the Bayview facility made millions more doses, whose fate is unclear. They surely will undergo additional quality checks, along with the plant itself, by the FDA, and that will take time, Dai said.

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Emergent operates another plant in Baltimore near the Camden Yards professional baseball and football stadiums, where it has helped package a crucial COVID-19 monoclonal antibody therapy.

Emergent did not respond to a request for comment about either Baltimore facility. And Johnson & Johnson has not addressed the latest shortages, with its last statement April 3 saying that the company was working with the FDA on authorization for the Bayview facility.

Dr. Joshua Sharfstein, a vice dean at the Johns Hopkins Bloomberg School of Public Health and a former FDA official, said the federal agency’s job is to ensure that the manufacturing itself is of high quality.

“I’m sure the focus is not only on this facility but other facilities so the public can have confidence in the products made,” he said.

In an appearance Thursday morning on WBAL Radio, Gov. Larry Hogan said he and the rest of the nation’s governors were blindsided Tuesday night when White House officials told them the nationwide distribution of Johnson & Johnson vaccines would be reduced by about 85% this week.

For Maryland, that meant going from about 90,000 of the single-shot immunizations to roughly 11,000, Hogan said, calling it a “big hit.”

Baltimore Sun reporter Alex Mann contributed to this article.