The U.S. Centers for Disease Control and Prevention (CDC) and Food and Drug Administration (FDA) have lifted the pause on the use of the Johnson & Johnson (Janssen) COVID-19 vaccine. The decision is based on the CDC’s Advisory Committee on Immunization Practices (ACIP) recommendation that health care providers resume the use of the Johnson & Johnson vaccine for adults aged 18 and above.
The CDC and FDA issued the following statement:
Following a thorough safety review, including two meetings of the CDC’s Advisory Committee on Immunization Practices, the U.S. Food and Drug Administration and the U.S. Centers for Disease Control and Prevention have determined that the recommended pause regarding the use of the Johnson & Johnson (Janssen) COVID-19 Vaccine in the U.S. should be lifted and use of the vaccine should resume.
Based on ACIP’s recommendations, the Maryland Department of Health (MDH) supports the reintroduction of the Johnson & Johnson vaccine. Maryland COVID-19 vaccine providers may resume using their available supplies of the Johnson & Johnson vaccine.
“The Johnson & Johnson vaccine is one of our most important tools in the ongoing fight to prevent hospitalizations and deaths associated with COVID-19,” said Dr. Jinlene Chan, MDH’s deputy secretary for public health services. “By resuming use of this safe and effective vaccine in Maryland, we will continue to bolster our ability to stay ahead of new cases and emerging variants.”
As part of this reintroduction, providers should share with patients updated information about the potential risks related to the vaccine, including the rare occurrence of thrombosis with thrombocytopenia syndrome (TTS), a condition where a rare type of blood clot is found in combination with low platelet levels.
Federal agencies carefully reviewed reported events of TTS in patients who received the Johnson & Johnson COVID-19 vaccine. Out of nearly 8 million doses of the Johnson & Johnson COVID-19 vaccine administered, 15 cases of TTS have been identified. Most such cases occurred in females ages 18 through 49 years, with the onset of symptoms one to two weeks after vaccination. Three cases have resulted in fatalities.
MDH believes that, while it is important to understand the risks of any medical therapy, the benefits of COVID-19 vaccines outweigh the risks of TTS. Providers should carefully review the following information from CDC and FDA:
MDH will follow up with additional guidance and information for clinicians.
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