LANSING, Mich. – Michigan is temporarily pausing the use of the Johnson & Johnson COVID-19 vaccine after reports of a few rare instances of blot clots forming in U.S. citizens who received that vaccine.
The decision comes after the Food and Drug Administration and Centers for Disease Control and Prevention both recommended a temporary pause while those cases are investigated.
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“More than 6.8 million doses of the Johnson & Johnson vaccine have been administered in the U.S., and these adverse events appear to be extremely rare,” said Dr. Joneigh Khaldun, chief medical executive of the Michigan Department of Health and Human Services. “However, out of an abundance of caution, we are following recommendations from FDA and CDC and pausing the use of the Johnson & Johnson vaccine in Michigan.”
Rare blood clot cases
According to national health officials, there have been six U.S. cases of a rare and severe type of blood clot forming in people after they received the Johnson & Johnson COVID vaccine.
Officials said a type of blood clot called cerebral venous sinus thrombosis and low levels of blood platelets were seen in these cases.
All six cases occurred in women between the ages of 18 and 48, and symptoms began six to 13 days after vaccination, according to authorities.
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Usually, an anticoagulant drug called heparin is used to treat blood clots, but in these instances, alternate treatments are used because administration of heparin could be dangerous, officials said.
This occurrence is extremely rare -- it’s been identified in just six people out of the 6.8 million who have received the Johnson & Johnson vaccine. Those numbers are as of April 12, officials said.
Nearly 200,000 doses of the Johnson & Johnson vaccine have been administered in Michigan, as of April 12.
Michigan pauses use of J&J
Michigan vaccine providers have been told not to administer the Johnson & Johnson vaccine while the CDC and FDA review those six cases and make sure any potential adverse reactions are being reported.
Clinics that have scheduled Johnson & Johnson vaccine appointments will either reschedule or use a different vaccine.
“As we learn more about this from our federal partners, we will update vaccine providers and Michiganders across the state,” Khaldun said. “We encourage everyone to continue making appointments to be vaccinated with the safe and effective Pfizer and Moderna COVID-19 vaccines at this time. These vaccines are the way we are going to end this pandemic as quickly as possible and move toward a sense of normalcy.”
CDC officials will convene a meeting of the Advisory Committee on Immunization Practices on Wednesday to further review these cases and their significance.
FDA officials will review that analysis as it also investigates these cases.
Until that process is complete, both the CDC and FDA are recommending a pause in the use of the Johnson & Johnson vaccine. Health experts said it’s important to make sure the health care provider community is aware of the potential for these adverse events, and can plan for proper recognition and management due to the unique treatment required.
People who have received the Johnson & Johnson vaccine who develop severe headache, abdominal pain, leg pain or shortness of breath within three weeks after vaccination should contact their health care provider. Health care providers are asked to report adverse events to the Vaccine Adverse Event Reporting System at this link.
“Safety is the first priority in vaccine authorization or approval,” Michigan officials said in a release. “The FDA has authorized the emergency use of COVID-19 vaccines after determining the vaccines meet FDA requirements. All of the authorized COVID-19 vaccines were found to be safe and effective in reducing the risk of severe illness, hospitalizations and death as caused by the virus. A robust process is in place to ensure the safety of any vaccine authorized or approved for use. More information about the safety of the COVID-19 vaccine is available here.”