A manufacturing plant in Baltimore, Maryland where two experimental COVID-19 vaccines are manufactured has caused the U.S. Food and Drug Administration (FDA) to delay authorization of the plant’s production lines due to the contamination of 15 million doses of Johnson & Johnson’s (J&J) COVID-19 vaccine.1
Ingredients Used in Two COVID-19 Vaccines “Mixed Up” During Production
The plant is operated by Emergent BioSolutions, which has been the sole manufacturer of anthrax vaccine purchased by the Department of Defense for use by military personnel and for the U.S. emergency vaccine stockpile.2 Emergent Biosolutions is a manufacturing partner to J&J and AstraZeneca, whose COVID-19 vaccine has not yet been granted Emergency Use Authorization (EUA) in the United States.3
Federal regulators have said that the contamination of J&J’s experimental Covid-19 vaccine occurred due to human error. Employees at the plant, which manufactures two different COVID-19 vaccines that use the same vector-based technology, mixed up the two vectors during the production process. J&J uses a human adenovirus vector and AstraZeneca uses a chimpanzee adenovirus vector and the two vaccines are biologically different and not interchangeable.4
The error went unnoticed for several days until Johnson & Johnson’s quality control team detected it. However, 15 million doses of the vaccine had been contaminated by then. The pharmaceutical company reported the error to the FDA, which has stopped the vaccine production lines until an investigation has been completed. It has been reported that none of the contaminated vaccines left the plant premises.5
Johnson & Johnson Put in Charge of the Manufacturing Plant
As a result of the contamination, the U.S. Department of Health and Human Services (HHS) has put J&J in charge of the manufacturing plant in Baltimore and has stopped the plant from producing the AstraZeneca/Oxford University COVID-19 vaccine. This change was made in order to avoid any future errors in the production process.6
Matt Hartwig, spokesperson for Emergent BioSolutions stated that the error was not a “result of people haphazardly adding the wrong ingredients to a batch” but that a biologic may not meet requirements for many reasons, which he did not specify. He added, “Unfortunately, this sort of thing can happen, especially as you rapidly scale up manufacturing capacity to over a billion doses annually.”7
Janet Woodcock, MD, FDA’s Acting Commissioner said that the responsibility of for vaccine production lies with J&J regardless of any contractors they employ. She stated:
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.8
Vaccination Sites Shut Down After J&J Vaccine Adverse Reaction Reports
In recent weeks, several vaccination sites around the country have shutdown due to reports that patients have been experiencing adverse reactions after receiving the J&J COVID-19 vaccine.9
Wake County, North Carolina paused giving the J&J vaccines at its COVID-19 vaccination site in PNC Arena in Raleigh after 18 people reported adverse reactions to the vaccine. The county issued a statement saying…
Wake County made the decision to pause today in partnership with the NC Department of Health and Human Services and after consulting with the manufacturer. Together, these teams continue to investigate the issue.”10
After an investigation, the U.S. Centers for Disease Control and Prevention (CDC) gave an all-clear approval to re-start the vaccination sites saying it “found no evidence of a safety concern for the J&J vaccine.11
Centura Health in Colorado said that it would no longer offer the J&J COVID-19 vaccine at three mass vaccination sites. Centura Health said the decision to stop offering the vaccine was based on adverse reactions that were reported earlier at a vaccination site.12
The Georgia Department of Public Health has stopped administering the J&J COVID-19 vaccine after several reports of people having adverse reactions to the vaccine in Cumming, Georgia. Kathleen E. Toomey, MD, MPH, Department of Public Health Commissioner said:
There is no reason to believe there is anything wrong with the vaccine itself, and other individuals who have received the J&J vaccine should not be concerned. We are looking into what happened and what may have caused the reactions, including the conditions at the fairgrounds such as heat and the ability to keep the site cool.”13
Federal officials say there is no connection between the contamination of the vaccine during the production process and the reports of the adverse reactions that shut down mass vaccinations sites in some parts of the country.14
U.S Temporarily Halts J&J Vaccine After Blood Disorder Reports
The FDA has asked states to temporarily stop using J&J’s COVID-19 vaccine after six people in the U.S. developed a rare blood disorder and reduced platelet counts after getting the vaccine.15
All six cases involved women between 18 and 48 years of age, with symptoms that started to developed six to 13 days after receiving the vaccine. The CDC said:
People who receive the vaccine and “develop severe headache, abdominal pain, leg pain, or shortness of breath within three weeks after vaccination should contact their health care provider.16
The CDC’s Advisory Committee on Immunization Practices (ACIP) and FDA are expected to launch an investigation. Anne Schuchat, MD, Principal Deputy Director of the CDC and Peter Marks, MD, director of the FDA’s Center for Biologics Evaluation and Research said:
Until that process is complete, we are recommending a pause in the use of this vaccine out of an abundance of caution.17
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Click here to view References:
1 LaFraniere S, Weiland N. Johnson & Johnson’s vaccine is delayed by a U.S. factory mixup. The New York Times Mar. 31, 2021.
2 Doyle E. White House scraps Biden vaccine event after report Baltimore company hogged stockpile funds. Washington Examiner Mar. 8, 2021.
3 LaFraniere S, Weiland N. Johnson & Johnson’s vaccine is delayed by a U.S. factory mixup. The New York Times Mar. 31, 2021.
6 Stolberg S. After Baltimore plant’s mix-up ruined millions of COVID vaccine doses, U.S. puts Johnson & Johnson in charge of facility. Baltimore Sun Apr. 4, 2021.
9 Anderson N. Georgia becomes third state to shut down Johnson & Johnson vaccine site: report. Wavy Apr. 11, 2021.
10 Musumeci N. Second vaccine site paused after adverse reactions to Johnson & Johnson shots. New York Post Apr. 8, 2021.
11 Anderson B. North Carolina sites to resume Johnson & Johnson vaccines after CDC review. ABC7 Chicago Apr. 9, 2021.
12 Cleveland C. Centura Health Pulls Johnson & Johnson Vaccine From 3 Mass Vaccination Sites. CPR Apr. 10, 2021.
13 Reed K. After adverse reactions, Georgia vaccination site halts Johnson and Johnson COVID vaccine. 11Alive Apr. 9, 2021.
14 Flaherty A, Ebb S. J&J vaccine output to drop 85%, White House says issues tied to Baltimore facility. ABC News Apr. 9, 2021.
15 Lovelace Jr. B. FDA temporarily halts use of Johnson & Johnson vaccine due to rare blood clotting issues. CNBC Apr. 13, 2021.
17 Associated Press. US recommends ‘pause’ for J&J vaccine over clot reports. Boston25 News Apr. 13, 2021.