The Department of Public Health and Social Services (DPHSS) has resumed use of the Johnson and Johnson/Janssen (J&J/Janssen) vaccine following recommendations from the U.S. Centers for Disease Control and Prevention (CDC) and U.S. Food and Drug Administration (FDA) to lift the pause on the single-dose vaccine.
CDC and FDA have determined the following:
Use of the J&J/Janssen COVID-19 Vaccine should be resumed in the United States.
The FDA and CDC have confidence that this vaccine is safe and effective in preventing COVID-19.
The FDA has determined that the available data show that the vaccine’s known and potential benefits outweigh its known and potential risks in individuals 18 years of age and older.
At this time, the available data suggest that the chance of thrombosis-thrombocytopenia syndrome (TTS), a condition that causes low blood clots and low platelets, occurring is very low, but the FDA and CDC will remain vigilant in continuing to investigate this risk.
The pause was recommended earlier this month after reports of six cases of a rare and severe type of blood clot in individuals following administration of the Janssen COVID-19 Vaccine
Health care providers administering the vaccine and vaccine recipients or caregivers should review the Janssen COVID-19 Vaccine Fact Sheet for Healthcare Providers Administering Vaccine (Vaccination Providers) and Fact Sheet for Recipients and Caregivers, which have been revised to include information about the risk of this syndrome, which has occurred in a very small number of people who have received the Janssen COVID-19 Vaccine.
Additionally, DPHSS issued Physician’s Alert No. 2021-008, advising Vaccine Partners of the determination by the CDC and FDA to lift the pause on the use of the J&J/Janssen vaccine.
The J&J/Janssen vaccine will be available for eligible Guam residents later this week. More information will be provided once available.
(JIC Release No. 648)