(WWJ) The Michigan Department of Health and Human Services is urging providers across the state to start using the Johnson and Johnson COVID-19 vaccine again—for people 18 and older.
This comes following the U.S. Food and Drug Administration (FDA) and Centers for Disease Control and Prevention (CDC) recommendation to move forward with administering the vaccine—following an 11 day pause for a "thorough safety review" after rare reports of a blood clotting and low platelet syndrome in a handful of people who received it.
Dr Joneigh Khaldun, Michigan's Chief Medical Executive, said in a release that health officials are "glad" to be able to start using the J&J vaccine again: "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…."
During the pause, the FDA and CDC examined existing data to assess the risk of blood clots (thrombosis) involving the cerebral venous sinuses, or CVST, (large blood vessels in the brain) and other sites in the body including large blood vessels of the abdomen and veins of the leg; coupled with low platelets (thrombocytopenia).
FDA and CDC conducted "extensive outreach" to clinicians and healthcare providers to inform them of the risks, and to help them recognize the condition so they can administer the proper, unique treatment required when a patient has both blood clots and low platelets. Traditional treatment for blood clots using blood thinners can exasperate CVST.
A total of 15 cases of the syndrome have been reported to VAERS (Vaccine Adverse Events Reporting System), including the six original cases. The age range was 18 to 59, with the median age of 37.
Thirteen of the women were under the age of 50. Twelve of the reported cases had the blood clots in the brain. Three deaths were reported, while seven remain hospitalized. A total of 4 million women nationwide have received the J&J vaccine as of Wednesday. Symptoms began six to 15 days after vaccination.
See the full CDC statement here
The two agencies (FDA, CDC) 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.
To report adverse reactions to the vaccine, go to the Vaccine Adverse Event Reporting System.
To find a vaccination location and schedule an appointment, visit the Michigan.gov/Coronavirus website or the CDC COVID Vaccine Finder.
