Understanding the J&J Vaccine Pause

by | Apr 15, 2021 | COVID-19, Healthcare, Medical Devices, Pharmaceuticals, Quality, Regulatory, Risk Management, Vaccine

Breaking news hit early this week regarding potential problems with Johnson & Johnson’s one-shot COVID vaccine, causing the FDA and the CDC to recommend pausing the administration of the vaccine until further investigation can be completed. On top of canceled or rescheduled vaccine appointments, this news left many people wondering what this means for the overall vaccine administration efforts and what changes they could expect to see.

The pause of the J&J vaccine was brought on by a rare but serious side effect. There have been some reported cases of a rare blood clot related to the vaccine; occurring in veins that drain blood from the brain. This side effect has been reported in six women, ages 18 to 48, who had been vaccinated with the J&J shot. While six cases out of nearly 7 million doses demonstrates an extremely rare occurrence, the side effect is very serious; there is one reported case of death, and one patient in critical condition.1

So, what does this mean for public health and the overall vaccine supply? Luckily, it appears that the vaccine administration efforts will be able to continue without an obstacle, relying heavily on Pfizer and Moderna supplies. It was also a goal of the FDA to make it clear in their statement that this should not cause undue concern over the vaccines, this pause was initiated out of an over-abundance of caution. “Yesterday’s actions should give the American people confidence in the FDA and CDC, the thoroughness of their review process, and their commitment to transparency and protection of public health”, said Jeffrey Zients, one of the officials on the White House COVID-19 Response Team.2

As someone who works within the FDA space every day, I think the pause will allow the Agency to review the data and determine if there is a statistically significant relationship between the vaccine and the adverse events. We can probably expect to see changes in the labeling for the vaccine, and potentially a change in the targeted recipients (i.e. patients with no underlying health conditions, or patients under a certain age). I am grateful to all the people involved with the vaccine efforts, ensuring that vaccine administration will not be hindered despite this pause.

EMMA International provides full-circle solutions for all MedTech products, including biologics and pharmaceuticals. Give us a call at 248-987-4497 or email info@emmainternational.com to find out more!

1FDA (April 2021) Joint CDC and FDA Statement on Johnson & Johnson COVID-19 Vaccine retrieved on 04/14/2021 from: https://www.fda.gov/news-events/press-announcements/joint-cdc-and-fda-statement-johnson-johnson-covid-19-vaccine

2White House (April 2021) Press Briefing by White House COVID-19 Response Team and Public Health Officials retrieved on 04/14/2021 from: https://www.whitehouse.gov/briefing-room/press-briefings/2021/04/14/press-briefing-by-white-house-covid-19-response-team-and-public-health-officials-28/

Madison Green

Madison Green

Director of Technical Operations - Mrs. Green serves as EMMA International’s Director of Technical Operations. She has experience in technical writing, nonconforming product management, issue evaluations, and implementing corrective and preventative actions in the pharmaceuticals and medical device industries. She has experience cross-functionally between R&D, lean manufacturing operations, and RA compliance. Mrs. Green also has academic and work experience with human health-risk engineering controls, physiological biophysics, and clinical research. Mrs. Green holds a Bachelor of Science in Biosystems Engineering with a concentration in Biomedical Engineering from Michigan State University. She is also a Certified Quality Auditor (CQA), and is currently pursuing her M.S. in Quality Management.

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