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Michigan to pause use of Johnson & Johnson vaccine per FDA recommendation

"We will follow the FDA’s guidance to temporarily pause the Johnson & Johnson vaccine out of an abundance of caution."

LANSING, Mich — Michigan is putting a pause on the single-dose Johnson & Johnson COVID-19 vaccine in line with guidance from the federal government out of "an abundance of caution."

In a joint statement Tuesday, the Centers for Disease Control and Prevention and the Food and Drug Administration said they were recommending a pause in the use of the vaccine as they investigate blood clots in six women that occurred six to 13 days after vaccination. 

FDA officials said they expect to give an update within several days. 

The clots were observed in the sinuses of the brain along with reduced platelet counts — making the usual treatment for blood clots, the blood thinner heparin, potentially “dangerous.” Due to this, the organizations recommended pausing use of the vaccine, so they could give healthcare providers more information. 

"Right now, these adverse events appear to be extremely rare," the FDA said in its statement. "This is important to ensure that the health care provider community is aware of the potential for these adverse events and can plan due to the unique treatment required with this type of blood clot."

CDC's Advisory Committee on Immunization Practices will meet Wednesday to discuss the cases and the FDA has also launched an investigation into the cause of the clots and low platelet counts.

Following the announcement, Gov. Gretchen Whitmer’s office released the following statement Tuesday morning: 

The safety and health of Michiganders will always come first. We will follow the FDA’s guidance to temporarily pause the Johnson & Johnson vaccine out of an abundance of caution, and adapt our vaccine strategy going forward until a further review of the data can be conducted. With this latest development, it’s more important than ever for the federal government to implement a targeted strategy that allocates additional Pfizer and Moderna vaccines to hotspots like Michigan to slow the spread of COVID-19 and save lives. Governor Whitmer will continue fighting for the vaccines we need to protect Michiganders, so we can get back to normal as soon as possible.

Dr. Joneigh Khaldun, chief medical executive and chief deputy for health, also said that while the clotting cases are rare, the Michigan Department of Health and Human Services is following the pause recommendation out of an abundance of caution. 

“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.”  

Who does the pause impact?

The majority of J&J doses allocated to the state for this week went to colleges and universities for campus vaccination clinics. Michigan's Department of Health and Human Services along with local health departments are working with universities to determining next course of action. 

Michigan State University in partnership with Ingham County Health Department was able to shift to use of the Pfizer vaccine Tuesday morning and will continue using that vaccine for the remainder of its clinics this week, a spokesperson said. 

Originally, Ottawa County Department of Public Health (OCDPH) said a Friday clinic at Grand Valley State University would also be canceled, but Metro Health will now be providing Pfizer doses. 

So, the April 16 vaccination clinic at the university's Allendale campus will take place. 

Calhoun County switched to Pfizer at its Albion College clinic on Tuesday. Ferris State University is using Pfizer at its clinics, as well. Calvin University was able to get Moderna doses from Kent County to cover its clinics. 

Counties in the West Michigan area have been able to cover most clinics happening this week or weekend using Pfizer or Moderna doses, including in Kent County, Ionia County, Allegan County, Van Buren/Cass District and Berrien County. 

Long term impact

The FDA has said it expects to provide an update in the coming days, but local health officials expect it will take some time. 

The single-dose, easier to store shot had made the shot more accessible.

"It's just very simple to use the vaccine, and so we saw that as something that could really help us get our community protected quickly," said OCDPH deputy health director Marcia Mansaray. 

J&J doses had been ideal for use in mobile vaccine clinics. In Allegan County, the health department says its mobile unit plans are now on hold. 

And community health centers like Catherine's Health Center in Grand Rapids had relied on the J&J shot to vaccinate patients who had transportation barriers and couldn't make it to second dose appointments as easily.  

Gov. Whitmer said Tuesday that she's hopeful the state will be able to move forward using the shot in the future once more information is known. Providers can store and save the doses until they are deemed safe to use, as long as that happens before the expiration date. 

Mansaray said like many things throughout the vaccination rollout there is a silver lining to Tuesday's news.

"And that is how seriously we take the safety of vaccination," she said.

More than 6.8 million doses of the J&J vaccine have been administered in the U.S., the vast majority with no or mild side effects. In Michigan, nearly 200,000 doses of the J&J vaccine have been administered. 

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 https://vaers.hhs.gov/reportevent.html.

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