05/16/22 Health Advisory: FDA Limits Use of Johnson & Johnson COVID-19 Vaccine.

Syringe drawing from a vial

Requested actions

  • Be aware, on May 5, 2022, because of the risk of thrombosis with thrombocytopenia syndrome (TTS) after getting Johnson & Johnson COVID-19 vaccine (J&J), Food and Drug Administration (FDA) limited its authorized use to people 18 years or older:
    • For whom other COVID-19 vaccines are not accessible or clinically appropriate.
    • Who want only J&J and would not otherwise get COVID-19 vaccine.
  • Be aware, on May 6, 2022, Washington State Department of Health (DOH) removed its standing order for J&J. Providers may continue, under their own standing orders, to give J&J to the people listed above.
    • Counsel those who get J&J of the risk of developing TTS 1–2 weeks after vaccination.
    • Do not give J&J to those with a history of TTS following J&J or any other adenovirus-vectored COVID-19 vaccine.
  • Report COVID-19 vaccine reactions to Vaccine Adverse Events Reporting System (VAERS) to maintain our nation’s robust vaccine safety surveillance system.
  • Continue to encourage people to get up to date on COVID-19 vaccination. Research continues to show COVID-19 vaccine saves lives.
  • Be aware, FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) will meet June 7, 2022 to discuss emergency use authorization (EUA) for Novavax’s protein-based COVID-19 vaccine. VRBPAC will meet later in June to discuss EUA for Moderna and Pfizer COVID-19 vaccine for younger populations.


FDA limited the authorized use of J&J to people age 18 years and older:

  • For whom other COVID-19 vaccines are not accessible or clinically appropriate.
  • Who want only J&J and would not otherwise get COVID-19 vaccine.

This decision came after FDA analyzed, evaluated and investigated reported cases of TTS after getting J&J. TTS is rare and includes potentially life-threatening blood clots in combination with low levels of blood platelets. Symptoms typically start 1–2 weeks after getting J&J.

In December 2021, Advisory Committee on Immunization Practices (ACIP) recommended mRNA COVID-19 vaccines over J&J for all people 18 years or older in the United States. Centers for Disease Control and Prevention (CDC) endorsed continuing to offer J&J to people with a contraindication to mRNA COVID-19 vaccines or who would otherwise remain unvaccinated.

As of March 18, 2022, FDA and CDC have identified 60 confirmed cases of TTS after getting J&J; 9 cases were fatal.

  • Rate of reported TTS cases: 3.23 per million doses of J&J.
  • Rate of reported TTS deaths: 0.48 per million doses of J&J.

In their analysis, FDA found rates of reported TTS and TTS deaths after J&J are not appreciably lower than previously reported. Furthermore, factors that put a person at risk for TTS after getting J&J remain unknown. FDA also considered:

  • People with TTS may rapidly deteriorate, despite prompt diagnosis and treatment.
  • TTS can lead to long-term and debilitating health consequences.
  • TTS has a high death rate.

FDA also considered the availability of other authorized and approved COVID-19 vaccines that provide protection from COVID-19 and have not been shown to present a risk for TTS.

FDA determined the known and potential benefits of J&J vaccine outweigh the known and potential risks for those 18 years or older who want only J&J and would not otherwise get COVID-19 vaccine or for whom other COVID-19 vaccines are not accessible or clinically appropriate.

More information

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Department of Health and Human Services (HHS) allocates monoclonal antibodies and oral antivirals to each state. DOH distributes doses to enrolled providers. Providers must enroll to order therapies in Healthcare Partner Ordering Portal (HPoP) to manage COVID-19 therapies. Email mcm@doh.wa.gov for support enrolling.

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