LANSING, Mich. (WLNS)– The Michigan Department of Health and Human Services is recommending vaccine providers across the state resume the use of the Johnson & Johnson vaccine to vaccinate Michiganders age 18 and older.
The news came Friday as the the U.S. Food and Drug Administration (FDA) and the U.S. Centers for Disease Control and Prevention (CDC) made the recommendation to move forward with administering the vaccine. The agencies previously recommended a pause on April 13 while experts conducted a thorough safety review after reports of a rare blood clotting syndrome in some people.
“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.”
To date, the agencies found a total of 15 cases of blood clots and low platelets, also known as thrombosis-thrombocytopenia syndrome (TTS). All of these cases occurred in women between the ages of 18 and 59, with a median age of 37 years. Reports indicated symptom onset between six and 15 days after vaccination.
Following a review of data, the FDA and CDC made these determinations:
- 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.