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 an abrupt recommendation by the federal government after reports of rare blood clotting cases.

The news sent Michigan public health officials scrambling Tuesday to reschedule appointments or cancel clinics for folks who had been slotted to receive the one-shot Johnson & Johnson version. Officials said there was still enough supply of Pfizer and Moderna two-dose shots to inoculate individuals in the state for several days, if not weeks.

The development came as Michigan continues to experience a surge in coronavirus cases and hospitalizations. The state has led the nation in new infections per population over the last seven days and on Tuesdayreported the 4,011 adults hospitalized with COVID-19 statewide is higher than the spring and fall 2020 surge peaks. 

Whitmer told WXYZ-TV on Tuesday that the Johnson & Johnson pause was an “unfortunate development." 

“If this tool is not in our toolbox, we’re going to need more help on the other fronts,” said Whitmer, whose calls for more vaccines have been refused by federal officials.

In Detroit, officials indicated Tuesday that they don’t anticipate a delay in the city's vaccination effort as a result of the Johnson & Johnson pause. Roughly, 98% of the city’s vaccinations have involved Moderna and Pfizer, said Detroit Mayor Mike Duggan. 

The city has enough of the Moderna and Pfizer vaccines that it will be able to handle anyone who was scheduled to receive the Johnson & Johnson vaccine this week so “from the city of Detroit standpoint, it doesn’t change strategy,” Duggan said.

“Detroit has had a Moderna-Pfizer-based strategy from the beginning. We’ve given out 250,000 doses; 246,000 have been Moderna-Pfizer,” he said.

Michigan is going to see the impact of Johnson & Johnson in places like pharmacies, which were getting the majority of the doses distributed rather than the health departments, Wayne County spokesman Bill Nowling said. 

“Places like stand-alone pharmacies were getting the lion's share of Johnson & Johnson. It will be a few weeks before we notice the impact from this,” he said. “In Wayne County, we don’t get as much Moderna anymore, mostly Pfizer because we have the ability to store it.”

Federal officials stressed they don't expect the pause to hamper the nation's vaccine supply, as they've ordered enough Pfizer and Moderna vaccines to inoculate all U.S. adults who want a shot. The Biden administration has secured enough Pfizer and Moderna doses for 300 million Americans, said White House COVID-19 Response Coordinator Jeff Zients said Tuesday.

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, he said.

"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.

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 rare blood clot in people who received the Johnson & Johnson shot, officials said. 

"This is a really rare event. If you look at what we know so far, there have been six out of the 6.85 million doses, which is less than one in a million," said Dr. Anthony Fauci, chief medical adviser to President Joe Biden, at a White House briefing. 

"Our FDA is internationally known for their capability of making sure that we have the safest products out there, and that's what I meant when I said (this was done out of) an abundance of caution." 

Whitmer's response

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

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."

But the head of the Centers for Disease Control and Prevention has said 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," said CDC Director Rochelle Walensky, 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 number of Johnson & Johnson available nationwide was already reduced after a mistake at a Baltimore manufacturing facility spoiled 15 million doses. 

More than 95% of the vaccine used by the 14-hospital Spectrum Health system in west Michigan has been Moderna or Pfizer vaccine, officials said.

“We are not concerned (about vaccine supply) at this point and have open availability for vaccinations to be given every day this week at the West Michigan Vaccine Clinic at DeVos Place" in Grand Rapids, said Dr. Liam Sullivan, an infectious disease physician at Spectrum Health.

Spectrum Health has 53,235 vaccine doses on hand, of which 131 vials or 655 doses are Johnson & Johnson vaccine, he said.

An advantage of the Johnson & Johnson vaccine is that it stores well, so Sullivan said he doesn’t expect any doses to spoil while the vaccine is on pause. It can stay in storage a long time, he said.

Clotting cases

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 health care 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 health care 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."

Natalio Barco, Detroit, receives the Johnson & Johnson vaccine from Z. Stokes, LPN, during a vaccination clinic at Western International High School in Detroit, Monday, April, 12, 2020. Andy Morrison/The Detroit News

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 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."

Impact of pause

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. 

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. 

Fauci 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."

Through Sunday, at least 3.35 million of 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. 

Local scramble

State and local officials were caught off guard by Tuesday's announcement and rushed to swap out Johnson & Johnson vaccines or to reschedule appointments and, when necessary, postponed clinics.  

Detroit said the city has a sufficient supply of Moderna and Pfizer doses to vaccinate everyone who had an appointment scheduled this week at the Northwest Activities Center or the neighborhood clinics for a Johnson & Johnson shot, according to Denise Fair, the city's chief health officer.

"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," Fair said in a statement.

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

In St. Clair County, one of Michigan’s hardest-hit counties during the current surge, Dr. Annette Mercatante, medical health officer for the county health department, told WPHM-AM Tuesday morning that much of the Johnson & Johnson vaccine allocation there had already been distributed.

St. Clair County has reported more new COVID-19 cases per population than any other Michigan county over the last 14 days. The county ranks 77th out of the 83 counties for the percentage of its population that has been completely vaccinated.

“It will have some impact, but I think we can switch gears and switch it to the MRNA vaccine pretty easily,” Mercatante told the radio station, referring to Pfizer and Moderna. “So it’s going to be one more bump. I think it’s going to be one more area that’s going to concern people.”

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

"Macomb County will continue its vaccination efforts leveraging Pfizer 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 said a vaccine fair planned in the city later this week has been canceled, but the city is scheduling another fair with Pfizer vaccine later this month.

Tuesday's clinic at the Eastern Michigan University Convocation Center, which Whitmer toured Monday, was postponed, but a clinic at Pierce Lake Elementary in Chelsea will use Pfizer vaccine. Wednesday clinics at Concordia University and EMU also were 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.

cmauger@detroitnews.com

Staff Writers Karen Bouffard and Beth LeBlanc contributed.