The Emergent BioSolutions manufacturing plant in East Baltimore that has been making coronavirus vaccine for months has not yet received emergency use authorization from the federal government, a spokesperson confirmed Wednesday, and the delay is reportedly due to a potentially egregious human error.
A mix-up of two vaccines’ ingredients several weeks ago ruined about 15 million doses of Johnson & Johnson’s vaccine and forced regulators to delay authorization of the plant’s production lines, The New York Times reported Wednesday. Emergent’s mistake does not affect Johnson & Johnson doses that are currently being delivered and used nationwide, The Times reported, but does affect future shipments.
Emergent, which contracted with Johnson & Johnson as well as AstraZeneca, is an experienced vaccine maker, producing its own products such as a smallpox vaccine kept in U.S. stockpiles. The company, based in Gaithersburg, has received millions in federal dollars to boost production of COVID-19 therapies and vaccines, including at the East Baltimore factory near Johns Hopkins Bayview Medical Center.
The company is awaiting emergency use authorization from the U.S. Food and Drug Administration for the Bayview facility, said spokesperson Matt Hartwig, but did not know when it would be granted. Hartwig declined to comment on how many doses of vaccine had been stalled because of the lack of authorization.
Alison Hunt, a spokesperson for the FDA, forwarded a reporter’s questions back to Emergent. Hartwig did not immediately respond to questions about the Times’ report.
Johnson & Johnson said in a statement that one batch of the drug substance at Emergent BioSolutions “did not meet quality standards” and was “never advanced to the filling and finishing stages of our manufacturing process.”
There are numerous test runs and quality checks conducted to make sure the product is up to par, the company said, and dedicated specialists on the ground who help with manufacturing.
“This is an example of the rigorous quality control applied to each batch of drug substance,” Johnson & Johnson said about catching the bad batch. “The issue was identified and addressed with Emergent and shared with the United States Food & Drug Administration.”
The company said that as it continues to work toward getting emergency authorization at the Bayview facility, it will provide additional experts in manufacturing, technical operations and quality who will be on-site to “supervise, direct and support all manufacturing of the Johnson & Johnson COVID-19 vaccine.”
Johnson & Johnson said by implementing those steps and working with the U.S. Department of Health & Human Services, it will stay on track to deliver 24 million single-shot vaccine doses through April. The company is still aiming to hit 100 million doses by the end of May.
Emergent has nine facilities globally, including one in South Baltimore near the city’s professional sports stadiums, where it fills vials of vaccines and therapies; that site is not involved with the J&J vaccine. The company grows cells to make vaccines in 2,000-liter bioreactors that resemble metal tanks in breweries. Depending on the vaccine, workers can brew tens to hundreds of millions of doses a year.
The New York Times reported this month that the federal government paid Emergent $626 million last year alone for products to fight a terrorist attack using anthrax after being repeatedly advised to do so, resulting in “less money to buy supplies needed in a pandemic.”
Emergent called that article “misleading,” and told The Sun that the company “feels strongly the U.S. government should fully fund preparedness for a wide range of threats, including pandemics and bioterrorism, and that choosing one over the other, or to partially fund everything at a low level, leaves the American public dangerously exposed.”
Baltimore Sun reporter Meredith Cohn contributed to this article.