Maryland health officials expect to see a drastic reduction in the state’s allocation of Johnson & Johnson’s COVID-19 vaccine next week, causing an approximately 33% reduction in the overall first-dose vaccination allotment compared to this week’s.
The state will have 78,000 fewer-than-expected doses of Johnson & Johnson’s single-dose vaccine next week, Maryland Department of Health spokesman Charles Gischlar said Thursday. He said the state had “no choice” but to impose allotment reductions statewide as a result of that shortfall.
“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 in a Thursday 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 reasoning behind the reduction. But it follows 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.
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 near Johns Hopkins Bayview Medical Center. Johnson & Johnson said in a statement that it found that a 15 million batch of urgently needed COVID-19 vaccine had to be destroyed because they did not meet the company’s quality standards.
The company previously said the error did not affect the vaccines already in circulation but would alter future shipments.
Meanwhile, the Emergent facility in Bayview also still lacks approval from the U.S. Food and Drug Administration, a spokesperson for the firm confirmed last month. 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.
The Emergent snafu and the latest Johnson & Johnson shortfall may be unrelated, said Tinglong Dai, associate professor of operations management & business analytics in the Johns Hopkins University Carey Business School, who studies vaccines.
Johnson & Johnson has contracts with the United States and the European Union, with 100 million doses promised to the former and 200 million pledged to the latter. 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.
“With the EU rollout, it is reasonable to expect some delay for J&J shipments in April,” Dai said.
But, he added, going forward, the 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.
The FDA did not respond to questions about the connection between Maryland’s vaccine drop off and the Emergent facility error, or about the status of Emergent’s other facilities.
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 the company was working with the FDA on authorization for the Bayview facility and that it still expects to deliver nearly 100 million single-shot doses of its vaccine to the U.S. government by the end of May.
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 on WBAL Radio Thursday morning, 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 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.”
The shortfall is far less than in other states, such as California, which is reporting close to a 90% reduction in doses.
In Maryland, however, Hogan said, several “mitigating factors,” including a bump in the supply of Pfizer/BioNTech and Moderna vaccines paired with the opening of the federally-run mass vaccination clinic in Greenbelt, lessened the blow.
”We’re making adjustments,” said Hogan, adding that the state expects providers will be able to fulfill existing vaccination appointments. “We’re hoping that they’ll fix this problem by next week.”
Baltimore Sun reporter Alex Mann contributed to this article.