Following a thorough safety review, the Centers for Disease Control and Prevention (CDC) and U.S. Food and Drug Administration (FDA) have lifted the pause on the administration of the Johnson & Johnson vaccine.
The Iowa Department of Public Health (IDPH) recommends that any vaccine provider in the state who has available Johnson & Johnson vaccine resume administration, effective immediately. The Trinity Muscatine Public Health Department will resume administering the vaccine as recommended by the CDC, FDA, and IDPH.
The pause was recommended after reports of six cases of a rare and severe type of blood clot in individuals following administration of the Johnson & Johnson vaccine.
The CDC and FDA issued the following:
• Use of the Johnson & Johnson 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) occurring is very low, but the FDA and CDC will remain vigilant in continuing to investigate this risk.
• 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) external icon and Fact Sheet for Recipients and Caregivers external icon, 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 Johnson & Johnson COVID-19 Vaccine.
The pause was an example of the extensive safety monitoring systems working as intended in the United States. The CDC and FDA have concluded that the known and potential benefits of the Johnson & Johnson COVID-19 vaccine outweigh the risks. They are also confident in the methods of treating these extremely rare occurrences.