Contact: Melissa Sixberry, Director of Disease Control                                                              509-249-6509

**Clinical leadership is expected to schedule time to review guidelines with staff**

 

Provider Alert: Johnson & Johnson vaccine paused due to safety alert.

April 13, 2021

Dear COVID-19 vaccine provider,

If you have ever been allocated Johnson & Johnson (Janssen) vaccine or currently have it in stock, please read this advisory very carefully.

The Washington State Department of Health is immediately pausing use of the Johnson & Johnson (Janssen) vaccine while the federal government begins an investigation into fully understanding recent safety events. Additionally, there will be no state allocations for Johnson & Johnson vaccine this week.

This action is being taken out of an abundance of caution based on the appearance of a rare but serious side effect including serious brain blood clots (CVST) combined with low platelet counts in six patients, all women under 50. This is very rare, 6 people out of 6.8 million doses given, but safety is the highest priority when it comes to all COVID-19 vaccines. The CDC’s Advisory Committee on Immunization Practices (ACIP) will review these cases in the days ahead and will recommend guidance going forward. We are considering this a temporary pause at this time until we learn more from these reviews.

Federal resources:

For those who got the vaccine more than a month ago, the risk of this complication is very low at this time. However, about 90,000 doses of Johnson & Johnson have been administered in Washington in the past two weeks.

Here is some information for vaccine providers on what to do with your Johnson & Johnson (J&J) vaccine stock and how to approach patients.

Do not administer J&J vaccine until further notice.

DOH will continue to monitor the situation related to J&J vaccine and update on its use as the pause is reviewed and once it is lifted.

Continue storing your J&J vaccine. Do not dispose of it. Here is a recap of J&J storage guidance:

Storage Prior to First Puncture of the Vaccine Vial

  • Store unpunctured multi-dose vials of the Janssen COVID-19 Vaccine at 36°F to 46°F (2°C to 8°C) and protect from light. Do not store frozen
  • Unpunctured vials of the vaccine may be stored between 47°F to 77°F (9°C to 25°C) for up to 12 hours

The Janssen COVID-19 Vaccine is initially stored frozen by the manufacturer, then shipped at 36°F to 46°F (2°C to 8°C). If vaccine is still frozen upon receipt, thaw at 36°F to 46°F (2°C to 8°C). If needed immediately, thaw at room temperature (maximally 77°F/25°C). Do not re-freeze once thawed.

  • At room temperature, a carton of 10 vials will take ~2 hours to thaw
  • At room temperature, an individual vial will take ~1 hour to thaw

Storage After First Puncture of the Vaccine Vial

  • After the first dose has been withdrawn, hold the vial between 36°F and 46°F (2°C to 8°C) for up to 6 hours or at room temperature (maximally 77°F/25°C) for up to 2 hours
  • Discard the vial if vaccine is not used within these times

Follow guidance in the CDC’s Health Alert for triaging patients who have received J&J or may report to you with the symptoms of concern. Common treatments such as heparin are not advised.

How to talk to your patients

For Patients Previously Vaccinated with J&J Vaccine:

  • Patients who received the J&J vaccine over three weeks ago are at very low risk for this complication.
  • People who have received the J&J vaccine within the last three weeks should contact you if they develop severe headache, abdominal pain, leg pain, or shortness of breath. You may also wish to reach out proactively to all patients who received J&J from you in the past three weeks and advise them to watch for these symptoms and contact you if they develop.
  • Almost 7 million Johnson & Johnson vaccines have been safely administered in the United States so far, so these 6 reports are being taken very seriously. The investigation into an event that takes place less than 1 in 1 million times is a sign that our safety monitoring system is working well.
  • Severe side effects to any vaccines are extremely rare.

 For Patients Currently Seeking Vaccination:

  • Moderna and Pfizer vaccines are currently available and recommended in place of the J&J vaccine. The main difference is that they both require 2 doses to provide full protection, rather than just one.
    • For assistance in discussing the Moderna or Pfizer vaccine with your patients, this Provider Discussion Guide on mRNA Vaccines may be useful in initiating the conversation and covers commonly heard questions and concerns.
  • If your location does not currently offer Moderna or Pfizer vaccine, help your patient locate a nearby location who does. You can assist your patient by using the Vaccinate WA: COVID-19 Vaccine Availability locator and schedule an appointment.
  • You may not administer J&J vaccine at this time, even if the patient requests it.

If you do have patients that present with these symptoms, please remember to report to VAERS.

We will send further information out as we get it. If you have any questions, please send them to covid.vaccine@doh.wa.gov.

 

Additional Resources – COVID-19 Vaccine

  1. covidvaccinewa.org
  2. Yakima County COVID-19 Vaccine DistributionWeb Site
  3. COVID-19 Vaccine Clinical Resources– CDC
  4. COVID-19 Vaccine Factsheet for Healthcare workers– CDC
  5. The COVID-19 Vaccine Confidence Conversation Starter for Healthcare Personnel– CDC