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April 28, 2021Johnson & Johnson COVID-19 Vaccine Distribution Resumes
April 26, 2021 – The U.S. FDA and Centers for Disease Control and Prevention (CDC) have lifted their recommendation to pause distribution of Johnson & Johnson’s (J&J) COVID-19 vaccine, manufactured by the company’s subsidiary Janssen.
The agencies initially recommended the pause on April 13, 2021, out of an abundance of caution while healthcare officials investigated reports of thrombosis-thrombocytopenia syndrome (TTS). An extremely rare syndrome, TTS occurs when a patient with low blood platelet levels (thrombocytopenia) develops thrombosis (when a blood clot blocks a blood vessel).
Following review of the available data, the FDA and CDC have determined the J&J vaccine is safe and effective in preventing COVID-19, and that potential benefits outweigh the known and potential risks.
An updated fact sheet for healthcare providers includes a warning about TTS and recommendations for treatment. The fact sheet advises that heparin, an anticoagulant often used to treat thrombosis, may be harmful if used to treat TTS and strongly recommends consultation with hematology specialists should TTS occur following administration of the J&J vaccine. In addition, it provides a link to information on treating TTS published by the American Society of Hematology.
The fact sheet for patients and caregivers has also been updated to provide information on the potential risk of TTS. It indicates that the chances of developing TTS are remote, and that patients should seek medical attention immediately if they experience any of the following after receiving the vaccine:
- Shortness of breath
- Chest pain
- Leg swelling
- Persistent abdominal pain
- Severe or persistent headaches or blurred vision
- Easy bruising or tiny blood spots under the skin beyond the site of the injection
According to the FDA and CDC, there were 15 confirmed TTS cases and 7.8 million doses of J&J vaccine administered as of April 21, 2021. The confirmed cases occurred in females 18-59 years of age, with a time to symptom onset of 6-15 days following vaccine administration. In all but two instances, the patients developed cerebral venous sinus thrombosis (CVST), a blood clot in the vessels that channel blood out of the brain. Three of the confirmed TTS cases were fatal. The FDA and CDC are closely monitoring adverse effects through vaccine side effect reporting programs.
Additional information is available on the FDA’s website.