'Human Error' At Baltimore Facility Ruined Millions of Johnson & Johnson Vaccine Doses, Report Says
BALTIMORE (WJZ) -- "Human error" at Emergent BioSolutions' highly-touted vaccine facility in Baltimore may have ruined 15 million doses of the Johnson & Johnson vaccine, according to a report Wednesday in the New York Times.
"Workers at a Baltimore plant manufacturing two coronavirus vaccines accidentally conflated the vaccines' ingredients several weeks ago, ruining about 15 million doses of Johnson & Johnson's vaccine and forcing regulators to delay authorization of the plant's production lines," the Times reported.
The facility makes the AstraZeneca as well as the Johnson & Johnson vaccines.
No Johnson & Johnson vaccine doses administered to the public have been tainted.
Governor Larry Hogan toured the facility in February and praised the work being done there.
According to the NYT, the issue has stopped future shipments of Johnson & Johnson doses in the United States while the Food and Drug Administration looks into the matter.
The facility manufactures the active material for the vaccines. WJZ has also learned, none of the Johnson & Johnson doses made with that material in Baltimore has been used on the public because the FDA has yet to approve the facility.
Emergent said earlier Wednesday they were awaiting that approval, which the NYT reported is delayed because of the vaccine mix-up.
WJZ has reached out to Emergent BioSolutions for a comment on the New York Times report and has not yet received a response.
President Biden abruptly canceled a visit to Emergent's Baltimore facility in early February.
Johnson & Johnson wrote in a statement:
"As with the manufacturing of any complex biologic medication or vaccine, the start-up for a new process includes test runs and quality checks to ensure manufacturing is validated and the end product meets our high-quality standards. This approach includes having dedicated specialists on the ground at the companies that are part of our global manufacturing network to support safety and quality. This quality control process identified one batch of drug substance that did not meet quality standards at Emergent Biosolutions, a site not yet authorized to manufacture drug substance for our COVID-19 vaccine. This batch was never advanced to the filling and finishing stages of our manufacturing process.
This is an example of the rigorous quality control applied to each batch of drug substance. The issue was identified and addressed with Emergent and shared with the United States Food & Drug Administration (FDA)."
You can read the full statement by clicking here.
This issue comes as Maryland is seeing COVID-19 infections and the positivity rate rise.
It is highest in Harford County—at 9.3%—more than doubling in the past month with Aberdeen, Abingdon and Edgewood leading in new cases.
While Harford County Executive Barry Glassman is monitoring the numbers, he sees no need for more restrictions. He is urging people to keep socially distanced and wear masks.
Harford County's Health officer says 20- to 50-year-olds are behind the rise. You can watch his comments here.
Maryland is also seeing an increase in more contagious strains with U.K. variant cases increasing 11% to 471 over the past week; the CDC also reports 37 South African variant cases and 1 case of the Brazilian variant.
In Baltimore City, the positivity rate is 3.7%but Infections have more than doubled in the past month.
Deaths are down 22% in that period.
For the latest information on coronavirus go to the Maryland Health Department's website or call 211. You can find all of WJZ's coverage on coronavirus in Maryland here.
