05/12/22 Health Advisory: FDA Limits Use of Johnson & Johnson COVID-19 Vaccine.

| May 12, 2022
Syringe in 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.
  • Be aware, because DOH removed its standing order, we will no longer give J&J at our vaccine events.
  • 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.
  • Increase access to Evusheld COVID-19 pre-exposure prophylaxis for people who are 12 years or older and weigh at least 88 pounds (40 kg) and:
  • To administer Evusheld, enroll in Healthcare Partner Ordering Portal (HPoP). Email mcm@doh.wa.gov for help enrolling.
  • To refer a patient to a provider who administers Evusheld, fax a referral to Birds Eye Medical at (360) 878-8330. Patients will be directed to a Wednesday or Friday specialty clinic at St. Francis Hospital.

Background

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

COVID-19 situation update

As of May 10, 2022, Pierce County has had 190,464 COVID-19 cases and 1,333 COVID-19 deaths. Our 14-day case rate per 100,000 is 244.7. Our 7-day new COVID-19 hospitalization rate per 100,000 is 3.3. You can see this data on the state’s data dashboard.

Pierce County COVID-19 data continue to show significant disparities by race and ethnicity, particularly affecting American Indian, Alaska Native, Black, Latinx, and Native Hawaiian and Other Pacific Islander communities. You can see these trends on our case data dashboard.

As of April 16, 2022, Pierce County residents received about 1,465,600 total doses of COVID-19 vaccine. 66% of Pierce County residents are fully vaccinated. See our COVID-19 vaccine data dashboard for details.

COVID-19 vaccine

COVID-19 testing

COVID-19 test processing

Labs report varying amounts of time to process COVID-19 tests. To support faster turnaround, we encourage providers to use in-state labs. The table below shows COVID-19 test processing times for in-state private labs. If you have questions about Health Department-facilitated antigen tests, contact epitesting@tpchd.org.

LabTime to process testTests processed daily
FidaLab24 hours300
Kaiser24–48 hours3,000
LabCorp24–48 hoursUnknown
Northwest Pathology12–24 hours3,000
Quest24–48 hours700
UW Virology24–72 hours5,000
Atlas Genomic24–48 hours10,000

COVID-19 therapy

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.

Additional information

COVID-19 prevention

Share with patients:

COVID-19 reporting

  • Cases in the following people—call (253) 649-1412.
    • Healthcare workers (e.g., EMS, medical, nursing, any healthcare facility employee).
    • Public safety workers (e.g., law enforcement, firefighter).
    • Live or work in a long-term care facility, senior living center, permanent supportive housing or similar congregate setting (e.g., shelter, correctional facility) housing people at high risk of severe outcomes.
    • Anyone who dies with COVID-19.
    • Anyone with suspected MIS-C.
  • All other cases—fax the following to (253) 649-1357 or call (253) 649-1413.
    • Patient—first name, last name, date of birth, gender, race, ethnicity, preferred language, phone number, address and zip code.
    • Specimen—collection date and type (NP, nasal swab, blood, etc.).
    • Test—type (PCR, NAAT, antigen, antibody/serology) and result (detected, not detected, inconclusive).
    • Ordering facility.
  • For all cases, report the person’s race, ethnicity and preferred language.

Contacting the Health Department

  • Urgent issues—call (253) 649-1412.
  • Non-urgent issues—call (253) 649-1413 and leave a message. Includes reporting notifiable conditions 24 hours a day, 7 days a week. Leave the patient’s name, date of birth and disease.

Additional resources