U.S. FDA and CDC recommend pausing use of J&J vaccine over blood clot concerns

The United States Food & Drug Administration (FDA) and Centers for Disease Control and Prevention (CDC) released a joint statement Tuesday, April 13, 2021, recommending a pause in the use of the Johnson & Johnson (J&J) vaccine out of an abundance of caution.¹

The agencies said they are reviewing data involving 6 reported U.S. cases of a rare and severe type of blood clot in individuals after receiving the vaccine, within about 2 weeks of vaccination.^1,2 The blood clot requires treatment that is different from that which might be typically administered, according to [CDC] [FDA] [both agencies].

Cases

The 6 blood clot cases occurred in women between ages 18 and 48. One recipient died.² A second has been hospitalized in critical condition.²

Nearly 7 million people in the U.S. have received J&J’s vaccine to date, and 9 million more doses have been shipped, according to data from the CDC.²

A pause has been issued while efforts are redirected to educating health care providers of the potential for adverse events and the specific treatment required for the rare type of blood clot observed.¹

The CDC stated it will convene a meeting of the Advisory Committee on Immunization Practices (ACIP) on Wednesday, April 14, 2021, to further review adverse event cases and assess their potential significance.¹ The FDA has stated it will review that analysis as it also investigates cases.

References

1. FDA. Joint CDC and FDA statement on Johnson & Johnson COVID-19 vaccine. April 13, 2021. Accessed April 13, 2021. https://www.fda.gov/news-events/press-announcements/joint-cdc-and-fda-statement-johnson-johnson-covid-19-vaccine

2. Weiland N, LaFraniere S, Zimmer C. U.S. Calls for Pause on Johnson & Johnson Vaccine After Rare Clotting Cases. NY Times. April 13, 2021. Accessed April 13, 2021. https://www.nytimes.com/2021/04/13/us/politics/johnson-johnson-vaccine-blood-clots-fda-cdc.html