Janssen (J&J) COVID Vaccine to Resume in the United States

April 26, 2021

Dear Colleague: 

After a thorough safety review, the U.S. Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC) have determined that the use of Janssen (J&J) COVID vaccine should resume in the United States. As such, the Georgia Department of Public Health (DPH) COVID Vaccine Program will again offer J&J vaccine to Georgians aged 18 and older. 
 
A warning will be added to the J&J vaccine about the potential for very rare, but severe blood clots associated with the vaccine. Vaccine providers administering the J&J vaccine should review the Janssen COVID-19 Vaccine Fact Sheet. Vaccine recipients and/or their caregivers should be provided with the Janssen COVID-19 Vaccine Fact Sheet for Recipients and Caregivers. Both fact sheets now include information about thrombosis and thrombocytopenia syndrome which have occurred in a very small number of people who have received the J&J vaccine. 

Vaccine providers in Georgia may restart J&J vaccine administration using existing inventory, provided it was properly stored during the pause. Providers may resume orders for the J&J vaccine beginning April 26, using the ordering link https://www.surveymonkey.com/r/GA-COVID19-Orders. Orders submitted by 5 pm, Tuesday, April 27, will be considered for allocation this week, with deliveries arriving the week of May 2. 
 
The surveillance systems that are in place to monitor the safety of COVID-19 vaccines are working as evidenced by the quick response to identify and investigate these adverse events. It is critically important that all healthcare and vaccine providers report adverse events following vaccination using the Vaccine Adverse Event Reporting System. 

The FDA and CDC have confidence that J&J vaccine is safe and effective in preventing COVID-19, and that its known and potential benefits outweigh its known and potential risks. The chance of these serious, sometimes fatal, adverse events occurring is very low. 

Please let me again remind all providers – regardless of whether they offer COVID-19 vaccines – about the importance of counseling patients about the availability and benefits of COVID vaccination.  Primary care and other physicians are often the most influential individuals to educate about the vaccine and reduce vaccine questioning. We will continue to provide you with the most updated information to ensure you have the best possible current information for your patients. 
 
Thank you for your collaboration to help stop the spread of COVID-19 and to keep Georgians healthy. 

Sincerely,

Kathleen E. Toomey, M.D., M.P.H.
Commissioner, Georgia Department 
of Public Health