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

Details

• Journal Article:
  Morbidity and Mortality Weekly Report
• Personal Author:
  Clark, Thomas A. ; Gee, Julianne ; Licata, Charles ; Liu, Ruiling ; Marquez, Paige ; Myers, Tanya R. ; Shay, David K. ; Shimabukuro, Tom T. ; Su, John R. ; Zhang, Bicheng
• Description:
  What is already known about this topic? An Emergency Use Authorization of the Janssen COVID-19 vaccine was granted February 27, 2021. Use was paused during April 12-23, 2021, after detection of six cases of cerebral venous sinus thrombosis (CVST). What is added by this report? By April 21, nearly 8 million doses of the Janssen COVID-19 vaccine had been administered. Review of safety monitoring data found that 97% of reported reactions after vaccine receipt were nonserious, consistent with preauthorization clinical trials data. Seventeen thrombotic events with thrombocytopenia have been reported, including three non-CVST events. What are the implications for public health practice? Ongoing monitoring for rare and common adverse events after vaccination is important for evaluating the balance between risks and benefits for each authorized COVID-19 vaccine, including the Janssen COVID-19 vaccine. [Description provided by NIOSH]
• Subjects:
  Adverse Drug Reaction Reporting Systems Autopsy Communicable Diseases Coronavirus COVID-19 COVID-19 Vaccines Demography Drug-Related Side Effects And Adverse Reactions Fatigue Health Care Facilities Workforce And Services Mortality Occupational Health Product Surveillance, Postmarketing Risk Assessment Safety Safety Management Surveys And Questionnaires Vaccines Viral Diseases

  More +
• Keywords:
  Vaccines; Health care; Humans; Immunizations; Medical treatment; Safety monitoring; Medical monitoring; Health surveys; Health effects; Biological effects; Blood clots; Platelets; Thrombosis; SARS-CoV-2; Coronavirus; COVID-19; Viral diseases; Disease control; Infection control; Recordkeeping; Recommendations; Infectious agents; Infection prevention; Surveillance; Surveillance programs; Risk analysis; Pain tolerance; Fatigue; Fatalities; Medical records; Death certificates; Autopsies; Data processing; Demographic characteristics
• Source:
  MMWR 2021 May; 70(18):680-684
• Series:
  Weekly Report: Morbidity and Mortality Weekly Report (MMWR)
• ISSN:
  0149-2195
• Document Type:
  Text
• Genre:
  Report
• Place as Subject:
  Georgia ; Ohio ; OSHA Region 4 ; OSHA Region 5
• CIO:
  National Institute for Occupational Safety and Health (NIOSH)
• Topic:
  Workplace Safety & Health
• Location:
  North America
• Pages in Document:
  5 pdf pages
• Contributor:
  Helfand, Rita F.
• Volume:
  70
• Issue:
  18
• NIOSHTIC Number:
  nn:20062587
• Contact Point Address:
  David K. Shay, MD, CDC COVID-19 Response Team, Atlanta, GA
• Email:
  dks4@cdc.gov
• Federal Fiscal Year:
  2021
• Peer Reviewed:
  False
• Collection(s):
  Morbidity and Mortality Weekly Report (MMWR) National Institute for Occupational Safety and Health
• Main Document Checksum:
  urn:sha-512:53dd3fe146cd60ac138e4a442f97fa0b7775e1e21d9601b8f6c6f56dc6954fcfef81197ba5e8ac6f6c3f660b45fd41988dde6d99075085ca89f0f8881f702284
• Download URL:
  https://stacks.cdc.gov/view/cdc/105633/cdc_105633_DS1.pdf
• File Type:
  [PDF - 138.13 KB ]