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Michigan pauses J & J vaccine, prompting scramble in state’s rollout

The Johnson and Johnson vaccine makes up a small portion of Michigan’s vaccines, but its single-dose administration makes it strategically important. (photo by Dan Welihan)

July 13: The Johnson & Johnson vaccine and Guillain Barré syndrome: what to know
April 23 update: FDA ends pause on J & J vaccine for COVID, but with warning to wome
Related: Halted vaccine was key to reaching hard-to-reach Michigan. Now what?

Michigan will immediately pause the use of one of three COVID-19 vaccines, after federal authorities on Tuesday warned of rare reports of women developing blood clots up to two weeks after receiving the shots.

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There were six reported cases of blood clots out of more than 6.8 million doses of the Johnson & Johnson vaccine that have been given in the U.S. The state had expected 17,500 additional doses of the one-dose J & J vaccine to be delivered this week, but several health departments say they will immediately cancel plans to use those.

“This really is a testament to the system working...Something that was concerning was elevated to the pause button,” said Nick Derusha, president of the Michigan Association of Local Public Health.

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“Folks will have an opportunity to take a very close look and find out if this was simply coincidence or if there's an item that we need to be concerned about,” Derusha said. 

Even a temporary halt of the one-dose J & J vaccine will complicate some of the state’s distribution efforts. 

Because it’s the only one of the three FDA authorized vaccines that is a single-dose, it was used strategically for hard-to-reach populations, such as rural or island residents, home-bound seniors, or those who public health officials need to get vaccinated quickly, such as college students who only recently became eligible for vaccination but will soon leave campus as the school year ends. 

That said, the J & J vaccine is not nearly as ubiquitous in Michigan as the other two approved options: the Pfizer and Moderna vaccines. There have been just under 200,000 J & J vaccines injected in Michigan, compared with a combined 5.2 million shots of the other vaccines.

The one-dose Johnson and Johnson vaccine is ideal for remote areas and hard-to-reach Michiganders. A plane delivered a health team and the vaccine to Bois Blanc Island in March. (Bridge photo by Dan Welihan)

According to a joint statement by the U.S. Food and Drug Administration and the U.S. Centers for Disease Control and Prevention, authorities discovered six cases of a “rare and severe type of blood clot” in women up to 13 days after they were vaccinated. 

Treatment for this particular blood clot — cerebral venous sinus thrombosis (CVST) — is different from treatment that might typically be administered, according to the joint statement. The CDC’s Advisory Committee on Immunization Practices (ACIP) will meet Wednesday to review the cases.

The single-dose J & J vaccine works differently than the other vaccines. Unlike Moderna’s and Pfizer’s, the J & J vaccine loads instructions to fight the coronavirus onto a common and harmless adenovirus, which can cause common flu or cold symptoms. It works like the AstraZeneca vaccine that is being used elsewhere, but not yet in the U.S.

“There's absolutely no concern about going and getting those (Pfizer and Moderna) vaccines. As a matter of fact, I have family members who are about to get their second dose just this week,” said the University of Michigan’s Dr. Arnold Monto, an international expert on the coronavirus and chairman of the FDA’s Vaccines and Related Biological Products Advisory Committee, or VRBPAC, which in December advised the FDA that the vaccine was safe and effective.

Unlike Pfizer and Moderna vaccines, which must be kept frozen, J & J doses can be refrigerated for long periods of time, meaning the doses that were scheduled to go into arms this week can still be used later, if they are cleared as safe.

Monto and others said they are concerned the six cases will fuel some people’s reluctance to get the vaccine.

“I worry about vaccine-hesitant people painting (the halt) with a broad brush and saying ‘Well then, none of (the vaccines) are safe.’ That’s not true,” Monto said. 

“What I will say to them is, ‘This shows how carefully safety is being considered. If there is any indication of a potential — not even a proven — side effect, the program is paused,’” he said.

“This shows how carefully safety is being considered,” Dr. Arnold Monto, an expert on coronavirus and advisor to the U.S. Food and Drug Administration, said the call to temporarily halt the J & J vaccine after rare complications were identified. (courtesy photo)

While the J & J vaccine made up just 3.7 percent of all doses in the state, it was counted on more heavily in rural parts of the state. It comprised, for instance, up to 12.5 percent of all COVID vaccines in Alcona County, and more than 5 percent in many other rural regions, according to state data.

On Mackinac Island, 160 seasonal workers Tuesday were to receive the vaccine, but the boat carrying the vaccines was canceled at the last minute and appointments were rescheduled for next week with the Moderna vaccine, said Derusha, who is also the health officer for the LMAS Health Department, which covers four eastern Upper Peninsula counties.

The state shipped 16,000 doses of the J & J vaccine to health departments late last week, earmarked for college students. Colleges had asked for J & J to avoid the possibility of only getting one dose of a two-shot regimen in students before they leave campus in late April or early May.

Students at Oakland University, in Rochester, signed up last week for J & J shots that were to begin Tuesday morning. Upon learning of the recommended halt, Oakland County Health Department officials were able to swap out J & J for the Pfizer vaccine in less than an hour. 

A clinic at Eastern Michigan University was canceled, according to the Washtenaw County Health Department.

At the University of Michigan, this week’s clinics in Ann Arbor will switch from J & J  to the Pfizer vaccine. Clinics scheduled for the Dearborn campus on Friday and the Flint campus on Wednesday and Thursday, as well as vaccinations next week on the Ann Arbor campus, are canceled.  “Michigan Medicine is working to reschedule these as supplies allow,” read a statement released by the university Tuesday.

Michigan State University administered 560 doses of the J & J vaccine to students last Friday, and scheduled 2,400 more for students through Friday. Those doses were swapped to the Pfizer vaccine before the campus’ vaccination clinic opened at 9 a.m. Tuesday.

“We are telling students verbally when they show up this morning that they are getting the Pfizer vaccine and will need to get a second dose,” MSU spokesperson Emily Guerrant said. “We believe, with a three-week wait (before a second dose) that we can see them again here before they leave” the campus for the semester.

Bridge data reporter Mike Wilkinson contributed to this report.

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