Situation Report | April 26, 2021
Following a safety review, the U.S. Food and Drug Administration (FDA) and Centers for Disease Control and Prevention (CDC) have determined the Johnson & Johnson (Janssen) COVID-19 vaccine should resume, lifting the recommended pause that had been in place to investigate reports of rare but severe blood clots.
On April 23, the CDC’s Advisory Committee on Immunization Practices (ACIP) voted to reaffirm its original, pre-pause recommendation that “the Janssen COVID-19 vaccine is recommended for persons 18 years of age and older in the U.S. population under the FDA’s Emergency Use Authorization” without any limitations by age, sex or other risk factors.
At this time, the available data suggest that the chance of thrombosis-thrombocytopenia syndrome (TTS) occurring is very low. The FDA and Janssen have agreed on a warning about thrombosis and thrombocytopenia which will be added to the vaccine’s Emergency Use Authorization (EUA), and the CDC has created a handout for vaccine recipients about this adverse event.
Health care providers administering the vaccine and vaccine recipients or caregivers should review the Janssen COVID-19 Vaccine Fact Sheet for Healthcare Providers and Fact Sheet for Recipients and Caregivers, which have been revised to include information about the risk of thrombosis-thrombocytopenia syndrome that has occurred in a very small number of people receiving the vaccine.
On April 24, the state Department of Health advised agencies that if they currently have Johnson & Johnson COVID-19 vaccine in stock, they may begin to use it immediately.
New York State expects to receive notification from the CDC of a small allocation of this vaccine tomorrow to be ordered and shipped to providers next week.
For providers enrolled in the New York State (outside of NYC) COVID-19 vaccination program, please submit a weekly planning request by 5 p.m. on Monday, April 26 if you are interested in being considered to receive an allocation of this vaccine next week.