- Be aware the U.S. Food and Drug Administration (FDA) updated the Johnson & Johnson/Janssen (J&J) COVID-19 vaccine Emergency Use Authorization (EUA) fact sheets to include possible risks of thrombosis with thrombocytopenia and Guillain-Barré Syndrome (GBS) following vaccination:
- Be aware the FDA extended the shelf life of J&J COVID-19 vaccine from 3 months to 4½ months. Visit Janssen’s lot expiry checker to determine the updated expiration of your vaccine.
- Continue to report myocarditis or pericarditis in people who got COVID-19 mRNA vaccine within the last 2 weeks.
- Promptly report cases to the U.S. Vaccine Adverse Events Reporting System (VAERS).
- Report cases to the Health Department’s 24-hour reporting line, (360) 778-6150. Include vaccine manufacturer, vaccine lot number, vaccination date, dose number, patient gender, age and history of prior SARS-CoV-2 infection.
- Be aware Washington State Department of Health (DOH) launched the Power of Providers initiative, to motivate and support providers to ask patients’ vaccination status, ask them about the vaccine and offer education, give vaccine or a referral, and empower patients to share their vaccination status. Sign up here to join the campaign.
- Vaccinate everyone 12 years or older against COVID-19.
- Make COVID-19 vaccination a new vital sign. Review all patients’ vaccination records and help them get up to date with all vaccines. You can administer COVID-19 vaccine simultaneous with, or within any number of days of, other vaccines.
Risk of Guillain-Barre Syndrome after Johnson & Johnson/Janssen vaccination
On July 8, the FDA updated its J&J EUA fact sheet to reflect an increased risk of GBS, a rare neurological complication, during the 42 days following J&J vaccination. GBS is a neurological disorder in which the body’s immune system damages nerve cells, causing muscle weakness and sometimes paralysis. VAERS received roughly 100 suspected cases of GBS among J&J vaccine recipients. Most cases were reported 2 weeks after vaccination among mostly men over 50. To date, 12.8 million doses of J&J vaccine have been administered in the U.S., suggesting a rate of 1 case per 128,000 people. The FDA lists the chance of getting this syndrome as “very rare.” So far, most cases reported have already recovered.
The FDA concluded that the “benefits of the vaccine in preventing severe COVID-19 and death much outweigh any danger.” The Centers for Disease Control and Prevention (CDC) and Western States Scientific Safety Review Workgroup continue to recommend all 3 COVID-19 vaccines equally. This is an evolving situation and we expect to hear more from the FDA and CDC. We will update you if anything changes. We expect the Advisory Committee on Immunization Practices (ACIP) will review the data on this rare occurrence at their next meeting on July 22. Given increasing COVID-19 variant infections and higher risk for virus spread, continued vaccination is critical to prevent increased disease.
If a patient refuses J&J COVID-19 vaccine, offer Moderna or Pfizer. It is important to continue protecting people against COVID-19.
People who previously had GBS may receive any of the COVID-19 vaccines.
Discard outdated J&J EUA fact sheets. When vaccinating patients with J&J, make sure you give them the most up to date EUA fact sheet for patients, which includes a description of what symptoms they should watch for. If patients call you with any of the following symptoms within 42 days of receiving J&J vaccine, advise them to seek medical attention right away:
- Weakness or tingling, especially in the legs or arms, that worsens and spreads to other parts of the body.
- Difficulty walking.
- Difficulty with facial movements, including speaking, chewing or swallowing.
- Double vision or inability to move eyes.
- Difficulty with bladder control or bowel function.
- COVID-19 vaccine locator, DOH.
- COVID-19 vaccine for providers
- COVID-19 vaccine provider toolkit and resources, DOH.
- COVID-19 vaccination for providers, CDC.
- Clinical considerations for COVID-19 vaccination and guidance for managing anaphylaxis, CDC.
- COVID-19 vaccine quick reference guide for healthcare professionals, CDC.
- COVID-19 vaccine training module on best practices for providers, CDC.
- Janssen (Johnson & Johnson) health alert, CDC.
- Vaccine-induced immune thrombotic thrombocytopenia frequently asked questions, American Society of Hematology (ASH).
- Diagnosis and management of vaccine-induced immune thrombotic thrombocytopenia webinar, ASH and CDC.
- April 15, 2021 Clinician Outreach and Communication Activity (COCA) call: Janssen (Johnson & Johnson) COVID-19 vaccine and cerebral venous sinus thrombosis with thrombocytopenia update for clinicians on early detection and treatment, CDC.
- Association of mRNA vaccines with myocarditis and pericarditis after vaccination:
- Follow-up of patients with myocarditis, consult recommendations, American Heart Association and the American College of Cardiology.
- Clinical considerations: Myocarditis and pericarditis after receipt of mRNA COVID-19 vaccines among adolescents and young adults, CDC.
- COVID-19 subcommittee of the World Health Organization (WHO) Global Advisory Committee on Vaccine Safety (GACVS) reviews cases of mild myocarditis reported with COVID-19 mRNA vaccines, WHO news release, May 26, 2021.
- Myocarditis and pericarditis following mRNA COVID-19 vaccination, CDC.
- Selected adverse events reported after COVID-19 vaccination, CDC.
- Myocarditis and pericarditis resources for the public, CDC.
We have test kits for you. Abbott Laboratories extended all BinaxNOW tests’ shelf life to 12 months. See Abbott’s BinaxNOW COVID-19 Ag Card Product Expiry Update for new expiration dates by lot number.
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.
|LAB||TIME TO PROCESS TEST||TESTS PROCESSED DAILY|
|Northwest Pathology||24-48 hours||20,000|
|UW Virology||18-24 hours||6,000-8,000|
|Atlas Genomic||16 hours||10,000|
Share the following materials with patients.
- What to do if you have COVID-19.
- What to do if you may have been exposed to COVID-19.
- What to do if you have COVID-19 symptoms and have not been tested or exposed.