CDC and FDA recommended a pause in the use of the Johnson & Johnson (Janssen) COVID-19 vaccine
J&J is currently pending an investigation into six reported U.S. cases of a rare and severe type of blood clot in individuals who received the vaccine.
As of April 12, 2021, approximately 6.85 million doses of the Johnson & Johnson (J&J) COVID-19 vaccine (Janssen) have been administered in the United States. The Centers for Disease Control and Prevention (CDC) and the U.S. Food and Drug Administration (FDA) are reviewing data involving six U.S. cases of a rare type of blood clot in individuals after receiving the J&J COVID-19 vaccine that were reported to the Vaccine Adverse Event Reporting System (VAERS).
In these cases, a type of blood clot called cerebral venous sinus thrombosis (CVST) was seen in combination with low levels of blood platelets (thrombocytopenia). All six cases occurred among women aged 18–48 years. Symptoms occurred 6 to 13 days after vaccination; currently there's been one dead.
Thus, these adverse events appear to be extremely rare, people who have received the J&J vaccine who develop severe headache, abdominal pain, leg pain, or shortness of breath within three weeks after vaccination should contact their health care provider. Health care providers are asked to report adverse events to the Vaccine Adverse Event Reporting System at https://vaers.hhs.gov/reportevent.htmlexternal icon
For Clinicians
Pause the use of the J&J COVID-19 vaccine until the ACIP is able to further review these CVST cases
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.
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.
Do not treat patients with thrombotic events and thrombocytopenia following receipt of J&J COVID-19 vaccine with heparin, unless HIT testing is negative.
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.
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.
For Public Health
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.
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.
Disseminate this alert to healthcare providers in your jurisdictions.
For the Public
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.
Report adverse events following receipt of any COVID-19 vaccine to VAERS.
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.
To learn more visit:
https://emergency.cdc.gov/han/2021/han00442.asp
https://www.cdc.gov/media/releases/2021/s0413-JJ-vaccine.html