On April 13, 2021, use of the Johnson & Johnson vaccine to immunize against COVID-19 was paused after reports of six cases of a rare and severe type of blood clot in individuals who received the vaccine. On April 24, the Centers for Disease Control and Prevention and the U.S. Food and Drug Administration determined known and potential benefits outweigh the vaccine’s known and potential risks and recommended its use resume in the U.S.
Hello, I’m Dr. Brooke Hildebrand Clubbs, instructor of Health Communication at Southeast Missouri State University. The Johnson and Johnson COVID-19 vaccine pause highlighted the work of the Vaccine Adverse Event Reporting System (VAERS).
In 1990, VAERS was established as a national early warning system to detect possible safety problems in U.S.-licensed vaccines. VAERS is co-managed by the CDC and the FDA . VAERS accepts and analyzes reports of adverse events after a person has received a vaccination.
The pause gave experts time to carefully review all available data and conduct a risk-benefit analysis. It also provided time to make health providers aware of the potential for these “one-in-a-million” adverse events so they could properly manage and recognize them. The National Blood Clot Alliance reports one in 3000 women who use hormonal birth control will experience blood clots. However, the type of clot related to the Johnson and Johnson vaccine requires a unique treatment compared to other blood clots.
Out of an abundance of caution, the CDC suggests women younger than 50 years old seek other COVID-19 vaccine options for which this risk has not been seen.
Resources:
• https://www.cdc.gov/coronavirus/2019-ncov/vaccines/safety/JJUpdate.html
• https://www.fda.gov/news-events/press-announcements/fda-and-cdc-lift-recommended-pause-johnson-johnson-janssen-covid-19-vaccine-use-following-thorough
• https://vaers.hhs.gov/about.html
• https://www.stoptheclot.org/learn_more/womens_health_faq/
