Updates for the Janssen and AstraZeneca Vaccines Cross-contamination

The severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) that causes COVID-19 pandemic has spread to over 220 countries and territories around the world as of July 2021. Up to the last 30 days, the ongoing pandemic has been causing ~186 million reported cases and ~4.0 million deaths globally. (1)

In response to global health crisis in 2020, the U.S. Secretary of the Department of Health and Human Services (DHHS) declared a public health emergency that justifies the emergency use of drugs and biological products during the COVID-19 pandemic.  On December 11, 2020, the U.S. Food and Drug Administration (FDA) issued the first emergency use authorization (EUA) under Section 564(b)(1) of the FD&C Act for a vaccine for the prevention of coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 16 years of age and older. (2-3)

Currently, there is no effective therapeutics for COVID-19, the only way to return to normal lives may be with safe and efficacious vaccines. To date, three COVID-19 vaccines under Authorized for Emergency Use in the US: Moderna (age 18+), Pfizer-BioNTech (age 12+) and Johnson & Johnson/Janssen (age 18+) (4). These are not fully approved vaccines to prevent COVID-19.

Janssen And AstraZeneca COVID-19 Vaccines Under EUA of Use

On February 27, 2021, the FDA issued EUA for the unapproved or licensed product, Janssen COVID-19 Vaccine, for active immunization to prevent Coronavirus Disease 2019 (COVID‑19) in individuals 18 years of age and older. (5-6)

However, AstraZeneca COVID-19 Vaccine is indicated for active immunization of individuals 18 years of age and older for the prevention of coronavirus disease 2019 (COVID-19), (7)  but it has not yet been approved by the FDA, because the FDA requested  AstraZeneca to show results from a large-scale clinical trial.

Two Vaccines, Same Technology

The Janssen and AstraZeneca COVID-19 vaccines use the same technology， which  is an adenovirus,  a common type of virus that typically causes mild cold symptoms when it infects someone.

COVID-19 viral vector vaccines inject a harmless adenovirus vector, which introduces unique genetic information from the COVID-19 virus to human cells. But both vectors are biologically different and not interchangeable.

The Janssen’s COVID-19 vaccine is composed of a recombinant, replication-incompetent human adenovirus type 26 vector, that, after entering human cells, expresses the SARS-CoV-2 spike (S) antigen without virus propagation. An immune response elicited to the S antigen protects against COVID-19.  (8)

Janssen’s vaccine has several benefits over  AstraZeneca, which makes them easier to store and transport. It can be kept refrigerated rather than frozen with longer shelf life and a single-dose regimen. This type of vaccine is good for rural areas without health care sites.

While AstraZeneca vaccines are ChAdOx1-S recombinant vaccines, (chimpanzee version), a non-replicating cold virus known as an adenovirus to deliver spike proteins into cells and produce an immune response. (7)

Recent data (9) indicated that doses of the AstraZeneca vaccine also contain significant amounts of protein from human cells—presumably from the human cell line used to grow the virus during the manufacturing process. 

Cross-Contamination of Covid-19 Vaccines

In late March 2021, employees at a biodefence plant, Emergent Biosolutions in Baltimore accidentally mixed ingredients (cross-contamination) of Johnson & Johnson and AstraZeneca vaccines, contaminating 15 million doses of the Johnson & Johnson product. (10)

FDA officials learned in April that up to 15 million doses of the Johnson & Johnson vaccine had been contaminated with the vaccine developed by AstraZeneca, then, FDA ordered Emergent Biosolutions  to stop producing vaccines for Johnson & Johnson and AstraZeneca and  to works with the FDA to resolve potential quality issues. 

Shortly afterward, FDA conducted inspections between 4/12/2021 and 4/20/2021 and released a report, (FEI-FDA Establishment Identifier Number: 3015448605) after a series of visits by federal regulators to the site, which documented a number of  serious issues with contamination, unsanitary conditions, mold, poor training and insufficient attention to procedures at Emergent Biosolutions plant in Baltimore that it said could potentially affect the quality of the vaccine products it made. (11)

Specifically, the FDA concluded that the biologic materials needed for the Johnson & Johnson vaccine had been contaminated with adenovirus as it moved through the facility’s “common weigh and dispense area” with materials from the AstraZeneca manufacturing area, which were not properly separated during the “waste transit” process, failed to follow SOP041888 v 3.0, SOP001518 v 15.0 and SOP001518 v 14.0 practices. It blamed faulty manufacturing practices for the incident. (11-12)

In late April, a spokesperson at Emergent BioSolutions said the company “has agreed to pause new production while it works with the FDA and Johnson & Johnson to resolve potential quality issues, help get additional doses released, and to resume production of this important COVID-19 vaccine. For the vaccines already manufactured, the products will undergo additional testing and will be thoroughly evaluated to ensure their quality before any potential distribution. We will not allow the release of any product until we feel confident that it meets our expectations for quality”.(13)

The Impact of Cross-Contamination

 On June 11, the FDA has decided at least 60 million doses of Johnson & Johnson’s COVID-19 vaccine made at the Emergent BioSolutions plant must be discarded,  in addition to the 15 million already thrown out that were contaminated by the AstraZeneca vaccine at the plant earlier this year. (14)

FDA also said that some batches made with the released drug substance from the Emergent facility could be used in the U.S. or exported to other countries. (15)

Allegedly, the European Union (EU)’s drug regulator made the announcement, saying that they will not use the Johnson & Johnson Covid-19 vaccines that were made at a Baltimore, Maryland plant. (14)

Same day, the Emergent BioSolutions announced that two batches of COVID-19 vaccine manufactured by Emergent BioSolutions at its Baltimore were determined to be suitable for use by the FDA and have been authorized as part of Johnson & Johnson’s Emergency Use Authorization (EUA). (16)

As noted, Emergent BioSolutions is actively addressing issues identified by the FDA at its Bayview facility and plans to resume manufacturing of the Johnson & Johnson COVID-19 vaccine drug substance after Emergent, Johnson & Johnson, and FDA are confident that the steps taken have remedied shortcomings.

However， the cross-contamination incident has cost the company a big fortune and reputation. On July 6, Emergent BioSolutions is facing at least four shareholder lawsuits filed June 29 in federal court in Maryland that accuses Emergent BioSolutions officials of selling a combined $20 million of personally held Emergent BioSolutions shares “on the basis of the nonpublic information about the problems at the Bayview Facility while the Company’s stock was artificially inflated.” So far, shares of Emergent BioSolutions are down 31.2% this year according to the New York Times report. (17)

References 

1 https://www.worldometers.info/coronavirus/countries-where-coronavirus-has-spread/

2 https://www.federalregister.gov/documents/2021/01/19/2021-01022/authorizations-of-emergency-use-of-two-biological-products-during-the-covid-19-pandemic-availability#:~:text=Section%20564%20%28b%29%20%281%29%20of%20the%20FD%26C%20Act,health%20and%20security%20of%20U.S.%20citizens%20living%20abroad.

3 https://www.vaccines.gov/search/

4 https://www.fda.gov/emergency-preparedness-and-response/coronavirus-disease-2019-covid-19/covid-19-vaccines

5 https://www.janssenlabels.com/emergency-use-authorization/Janssen+COVID-19+Vaccine-HCP-fact-sheet.pdf

6 https://www.fda.gov/emergency-preparedness-and-response/coronavirus-disease-2019-covid-19/janssen-covid-19-vaccine

7 https://covid-vaccine.canada.ca/info/pdf/astrazeneca-covid-19-vaccine-pm-en.pdf

8 https://www.cdc.gov/coronavirus/2019-ncov/vaccines/different-vaccines/janssen.html

9 https://www.researchsquare.com/article/rs-440461/v1

10 https://theprint.in/health/jj-knew-of-risks-at-baltimore-plant-months-before-vaccine-got-contaminated-washington-post/661732/

11 https://www.fda.gov/media/147884/download

12 https://www.cbsnews.com/news/covid-vaccine-plant-johnson-johnson-fda-inspection/

13 https://investors.emergentbiosolutions.com/news-releases/news-release-details/statement-issuance-form-fda-483-emergent-bayview-facility

14 https://welovetrump.com/2021/06/11/eu-suspends-johnson-johnson-vaccine/

15 https://www.fda.gov/news-events/press-announcements/fda-takes-steps-increase-availability-covid-19-vaccine

16 https://investors.emergentbiosolutions.com/news-releases/news-release-details/covid-19-vaccine-drug-substance-manufactured-emergent

17 https://www.nytimes.com/2021/07/06/us/emergent-biosolutions-vaccines-investors.html?utm_source=STAT+Newsletters&utm_campaign=c0c11a9d43-RO_COPY_04&utm_medium=email&utm_term=0_8cab1d7961-c0c11a9d43-151513817

About the Author

Lin Zhang, M.D., senior director of a health care industry company in the United States. With the experience in clinical medicine, biotechnology, health industry and other fields, he is responsible for the research and development of plant medicine, functional food and health products. He was a clinician and worked for the National Cancer Institute, FDA and the National Cancer Center of Japan for many years.