The Food and Drug Administration (FDA) and Centers for Disease Control and Prevention (CDC) recommended on April 13, 2021 a pause in administering the Johnson & Johnson (J&J) single dose vaccine. This safety pause was recommended so that national experts could review cases of a blood clotting side effect among women aged 18 – 50 in the U.S.
Following this review, the FDA lifted the recommended pause on the use of the J&J vaccine and expressed confidence in the vaccine’s safety and effectiveness, citing analysis that determined the risk of blood clots was very rare.
Based on this information, the Ardent CMO Operating Committee recommends the following:
- For women ages 18-50, if available, seek an alternate COVID-19 vaccine (Pfizer, Moderna)
- Avoid the J&J vaccine for patients taking oral contraceptive medications or have a history of venous thrombosis (deep vein thrombosis, pulmonary embolism, etc.) or other known thrombophilia disorder (Factor V Leiden, Prothrombin mutation, etc.).
- Avoid the J&J vaccine for patients with any history of thrombocytopenia.
If you have any questions, please speak with your healthcare provider.