CDC Issues Health Alert on Johnson & Johnson COVID-19 Vaccine

Mary Madison, RN, RAC-CT, CDP
Clinical Consultant – Briggs Healthcare

At this point on Tuesday, April 13, 2021, I hope you’ve see the joint CDC and FDA media statementadvising providers to pause administration of the Johnson & Johnson (Janssen) COVID-19 vaccine, pending an emergency meeting on April 14, 2021.

On April 13, 2021 at 1pm (ET), the CDC further issued an extensive Health Alert Network statement on cases of Cerebral Venous Sinus Thrombosis with Thrombocytopenia after receipt of the Johnson & Johnson COVID-19 vaccine.  This health alert contains a great deal of information about this condition following the J&J vaccine.

Recommendations for Clinicians:

  1. Pause the use of the J&J COVID-19 vaccine until the ACIP is able to further review these CVST cases in the context of thrombocytopenia and assess their potential significance.
  2. Maintain a high index of suspicion for symptoms that might represent serious thrombotic events or thrombocytopenia in patients who have recently received the J&J COVID-19 vaccine, including severe headache, backache, new neurologic symptoms, severe abdominal pain, shortness of breath, leg swelling, petechiae (tiny red spots on the skin), or new or easy bruising. Obtain platelet counts and screen for evidence of immune thrombotic thrombocytopenia.
  3. In patients with a thrombotic event and thrombocytopenia after the J&J COVID-19 vaccine, evaluate initially with a screening PF4 enzyme-linked immunosorbent (ELISA) assay as would be performed for autoimmune HIT. Consultation with a hematologist is strongly recommended.
  4. Do not treat patients with thrombotic events and thrombocytopenia following receipt of J&J COVID-19 vaccine with heparin, unless HIT testing is negative.
  5. If HIT testing is positive or unable to be performed in patient with thrombotic events and thrombocytopenia following receipt of J&J COVID-19 vaccine, non-heparin anticoagulants and high-dose intravenous immune globulin should be strongly considered.
  6. Report adverse events to VAERS, including serious and life-threatening adverse events and deaths in patients following receipt of COVID-19 vaccines as required under the Emergency Use Authorizations for COVID-19 vaccines.

Recommendations for Public Health:

  1. Pause the use of the J&J COVID-19 vaccine in public health clinics until the ACIP is able to further review these CVST cases in the context of thrombocytopenia and assess their potential significance.
  2. Encourage healthcare providers and the public to report all serious and life-threatening adverse events and deaths following receipt of COVID-19 vaccines to VAERS as required under the EUAs for COVID-19 vaccines.
  3. Disseminate this alert to healthcare providers in your jurisdictions.

Recommendations for the Public:

  1. If you have received the J&J COVID-19 vaccine and develop severe headache, abdominal pain, leg pain, or shortness of breath within three weeks after vaccination, contact your healthcare provider, or seek medical care.
  2. Report adverse events following receipt of any COVID-19 vaccine to VAERS.
  3. If you are scheduled to receive the J&J vaccine, please contact your healthcare provider, vaccination location, or clinic to learn about additional vaccine availability.

There are also resources available for additional information found at the end of the HAN alert.