April 30, 2021

Safety Monitoring of the Janssen (Johnson & Johnson) COVID-19 Vaccine — United States, March–April 2021

Category: Article Summary

Topic: Vaccines and Immunity

Keywords (Tags): vaccines

• A review of post-authorization safety data after administration of 7.98 million doses of Johnson & Johnson/Janssen COVID-19 vaccine during March–April 2021 found that commonly-reported reactions, such as fatigue and pain, were similar to those observed in clinical trials, and 97% of these events were classified as nonserious. A total of 17 events consistent with cerebral venous sinus thrombosis (CVST) and 3 events of non-CVST thrombosis events were reported in women <60 years. 88 deaths occurred post vaccination and 3 of these occurred in persons with CVST, while the remaining 85 were determined to not be associated with vaccination. 

Shay et al. (Apr 30, 2021). Safety Monitoring of the Janssen (Johnson & Johnson) COVID-19 Vaccine — United States, March–April 2021. MMWR. Morbidity and Mortality Weekly Report. https://doi.org/10.15585/mmwr.mm7018e2