Michigan will move forward with administration of the Johnson and Johnson vaccine after FDA and CDC guidance following a safety review.
The Michigan Department of Health and Human Services is recommending that vaccine providers in the state resume use of the Johnson and Johnson vaccine for residents 18 and older.
The FDA and CDC paused use of the vaccine on April 13 while experts conducted a safety review after reports of blood clotting in some women.
During the pause, experts from the FDA and CDC examined all available data as well as extensive outreach to providers to ensure they were aware of the rare adverse effects.
The two agencies have determined the following:
- Use of the Jonson & 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 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) 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.
“We are glad to be able to begin administering the Johnson & Johnson vaccine again in Michigan following the thorough review and recommendations of ACIP, CDC and FDA,” said Dr. Joneigh Khaldun, chief medical executive and chief deputy for health. “This brief pause indicates there is a robust safety review process in place for these vaccines. These adverse events appear to be extremely rare as nearly 7 million doses of the Johnson & Johnson vaccine have been administered in the U.S. with only 15 cases of this blood clotting syndrome confirmed. We encourage everyone to continue making appointments to be vaccinated with the safe and effective Johnson & Johnson, Pfizer and Moderna COVID-19 vaccines. These vaccines are the way we are going to end this pandemic as quickly as possible and move toward a sense of normalcy.”
If you believe you are feeling adverse effects following your vaccination, you can report them here.
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