Michigan halts Johnson & Johnson vaccine, following federal guidance

Lansing — Gov. Gretchen Whitmer’s administration is pausing use of the Johnson & Johnson COVID-19 vaccine in Michigan following a Tuesday recommendation by the federal government.

Federal officials said Tuesday they don’t expect the development to hamper vaccine supply, as they’ve ordered enough Pfizer and Moderna vaccines to inoculate all adults who want a shot. 

The pause is expected to last only “a matter of days,” depending on what scientists and physicians learn about six cases of a type of very rare blood clots in people who received the Johnson & Johnson shot, officials said. 

The Michigan Department of Health and Human Services is not aware of any of the six cases being in Michigan, a spokeswoman said Tuesday.

The pause on one of the three COVID-19 vaccines being administered in the United Statescomes as Michigan continues to experience a surge in coronavirus cases and hospitalizations.

Michigan has led the nation in new infections per population over the last seven days and reported a higher number of adults hospitalized with COVID-19 than the peak during the fall surge of cases.

Whitmer spokesman Bobby Leddy repeated Tuesday the governor’s call for the federal government to allocate additional Pfizer and Moderna vaccines to Michigan amid the surge in infections pummeling the state.

Pharmacist Nabilah Seblini fills a syringe with the Johnson & Johnson vaccine during a vaccination clinic at Western International High School in Detroit, Monday, April 12, 2020.

“The safety and health of Michiganders will always come first,” Leddy said. “We will follow the FDA’s (Food and Drug Administration) 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 hot spots like Michigan to slow the spread of COVID-19 and save lives,” Leddy added.

“Gov. Whitmer will continue fighting for the vaccines we need to protect Michiganders, so we can get back to normal as soon as possible.”

But the head of the Centers for Disease Control and Prevention has said that the answer to Michigan’s “acute situation” with COVID-19 is not to surge vaccines but to shut down the state and “flatten the curve.” 

“I think if we tried to vaccinate our way out of what is happening in Michigan, we will be disappointed that it took so long for the vaccine to work — to actually have the impact,” CDC Director Rochelle Walensky said, noting vaccines take two to six weeks to take effect.

Michigan has administered nearly 200,000 doses of the one-shot Johnson & Johnson vaccine, according to state data, and Detroit has administered 5,000 doses. At least 328,700 doses of the Johnson & Johnson vaccine had been distributed to providers in Michigan as of Monday. 

The most doses were administered in Oakland County (19,108 doses), Wayne County (19,017), Macomb County (17,472), Kent County (12,431), Genesee County (8,741) and Washtenaw County (7,886).

The Detroit Health Department said Tuesday it also had halted the use of the Johnson & Johnson vaccine until further notice from federal officials.

The voluntary pause came after theCDC and the Food and Drug Administration recommended the move Tuesday morning, following reports of a type of severeblood clot that the agencies labeled “extremely rare.”

Federal officials said they’re aware of six reports of the blot clots, out of more than 6.8 million doses of the Johnson & Johnson vaccine that have been administered in the United States.

Of those six, one case was fatal and another patient is in critical condition after presenting with a type of blood clot known as cerebral venous sinus thrombosis, or CVST, in combination with low levels of platelets in the blood, said Dr. Peter Marks, director of FDA Center for Biologics Evaluation and Research.

The blood clots occurred in women ages 18 to 48, whose symptoms arose between six and 13 days after receiving the Johnson and Johnson vaccine, Marks said. 

Acting FDA Commissioner Janet Woodcock stressed that her agency took this step in part to prepare the healthcare industry to know how to treat these patients, and that her agency remains committed to vaccination. 

“We feel we’re taking the route that will provide the most safety for the patient by enabling healthcare professionals to recognize to properly treat and properly report any of the events that might happen,” Woodcock said on a call with reporters.

“Lastly, I know there are people who have gotten the vaccine, who are probably very concerned. For people who got the vaccine more than a month ago, the risk for them is very low at this time.”

Woodcock added that, for people who got the vaccine within the last couple of weeks, they should seek medical treatment if they develop symptoms such as severe headaches, abdominal pain or shortness of breath.

Treatment of CVST is different than typical treatments for other types of blood clots, which usually involve an anticoagulant called heparin, Marks said. But heparin may be dangerous for CVST patients, and alternative treatments need to be given, he said.

An FDA advisory committee will convene Wednesday to review the data on the initial cases and to decide what to do next.

“When we saw this pattern and were aware that treatment needed to be individualized for this condition, it was of the utmost importance for us to get the word out,” said Dr. Anne Schuchat, principal deputy director for the CDC.

“That said, the pandemic is quite severe, and cases are increasing in a lot of places, and vaccination is critical. So we want to make sure that we make some recommendations quickly.”

White House COVID-19 Response Coordinator Jeff Zients said Tuesday that the pause is recommended “out of an abundance of caution” while the FDA and CDC investigate. 

“This announcement will not have a significant impact on our vaccination plan: Johnson & Johnson vaccine makes up less than 5% of the recorded shots in arms in the United States to date,” Zients said in a statement. 

“Based on actions taken by the president earlier this year, the United States has secured enough Pfizer and Moderna doses for 300 million Americans.” 

Officials are working with states and federal partners to reschedule anyone who was set to receive a Johnson & Johnson vaccine to get a Pfizer or Moderna vaccine instead, he said.

Marks said federal officials are aware of no reports of CVST with low platelets tied to individuals who have received the Pfizer and Moderna COVID vaccines, of which over 180 million doses have been administered. 

Dr. Anthony Fauci, chief medical adviser to President Joe Biden, noted there have been no negative red-flag signals raised regarding the Pfizer and Moderna versions and “that tells you you’re dealing with a really safe vaccine.”

“This is an extraordinary safety record that the others have,” Fauci said at a Tuesday briefing.

“And the fact that a pause was done just is a testimony to how seriously we take safety, and why we have an FDA and the CDC that looks at this very carefully. And hopefully we’ll resolve it pretty soon — within days to weeks.”

Zients said the government should still have enough supply of the Pfizer and Moderna vaccines to continue the pace of 3 million shots per day and to reach every adult who wants to be vaccinated.

He said federal officials have made available more than 25 million doses of Pfizer and Moderna each week and that this week it will make available 28 million doses. This is 

Through Sunday, at least 3.35 million Michigan’s 8.1 million residents 16 or older had received at least one dose of COVID-19 vaccine, with most getting the two-dose Moderna or Pfizer vaccines. 

Detroit had administered 251,655 doses of the 308,170 vaccine doses it has received from the state allocation, through Sunday, including the two-dose vaccines for Pfizer and Moderna. It was unclear how many were the Johnson & Johnson one-dose shots. The city has 32,000 future appointments scheduled.

“The city has a sufficient supply of Moderna and Pfizer (two-shot vaccines) to vaccinate everyone who had an appointment scheduled this week at the Northwest Activities Center or the neighborhood clinics for a J&J shot,” said Denise Fair, the city’s chief health officer, in a statement. 

“If you were scheduled for a J&J shot and want to keep your same appointment, you will be given the Moderna or Pfizer vaccine. You will receive a second dose 3-4 weeks later.”

Appointments at the TCF Center and Saturday community centers aren’t affected, Fair said, because they have always used the Pfizer or Moderna vaccines.

Macomb County Executive Mark Hackel said Tuesday morning the county health department will be making the substitution.

“Macomb County will continue its vaccination efforts leveraging Pifzer and Moderna doses, and we will be able to fulfill every scheduled appointment,” he said in a statement.

At a Tuesday clinic at Oakland University, Pfizer will be used.

Warren Mayor Jim Fouts announced Tuesday morning that a vaccine fair planned in the city later this week has been canceled.

“We will resume distribution of vaccines when it’s proven beyond a doubt that it is safe to do so,” he said in a statement. “We are also planning on having another vaccine fair with the Pfizer vaccine later this month.”

The Washtenaw County Health Department announced Tuesday that it also would pause its use of the J&J vaccine. Tuesday’s clinic at the Eastern Michigan University Convocation Center, which Whitmer toured Monday, is postponed, but a clinic at Pierce Lake Elementary in Chelsea will use Pfizer vaccine. Wednesday clinics at Concordia University and EMU will also be postponed.

In Livonia, those scheduled for vaccines Thursday through Livonia Fire & Rescue will be given Pfizer doses, officials said.

Appointments for Friday will be postponed until supplies are replenished.