Michigan Halts Johnson & Johnson Vaccines Due to FDA Concerns of Rare Blood Clots

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Detroit Free Press
April 13, 2021
Kristen Jordan Shamus, Dave Boucher, Christina Hall

Federal health officials recommended an immediate pause Tuesday on the use of Johnson & Johnson’s coronavirus vaccine “out of an abundance of caution” following reports of six cases of rare and serious blood clots in women in the United States.

The blood clots, the U.S. Food & Drug Administration announced in a series of tweets, are severe and extremely rare.

 

“In these cases, a type of blood clot called cerebral venous sinus thrombosis (CVST) was seen in combination with low levels of blood platelets (thrombocytopenia),” the FDA said in a statement.

“All six cases occurred among women between the ages of 18 and 48, and symptoms occurred six to 13 days after vaccination. Treatment of this specific type of blood clot is different from the treatment that might typically be administered. Usually, an anticoagulant drug called heparin is used to treat blood clots. In this setting, administration of heparin may be dangerous, and alternative treatments need to be given.”

Gov. Gretchen Whitmer and state health officials learned of the federal request for a pause at the same time as the general public. The state will follow the advice of medical professionals and stop the use of the Johnson & Johnson vaccine while the investigation is underway.

“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. 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,” said Dr. Joneigh Khaldun, the state’s chief medical executive, in a statement.

“As we learn more about this from our federal partners, we will update vaccine providers and Michiganders across the state. We encourage everyone to continue making appointments to be vaccinated with the safe and effective Pfizer and Moderna COVID-19 vaccines at this time.”

It couldn’t come at a worse time for Michigan, which is in the throes of the most severe COVID-19 outbreak in the nation. Whitmer has repeatedly asked the federal government to surge more vaccines to the state, where the per-capita COVID-19 case rate hit a seven-day average of 510.5 cases per 100,000 people Tuesday, according to the U.S. Centers for Disease Control & Prevention.

How long the pause will last

This is expected to be a “temporary pause,” said Peter Marks, director of the Center for Biologics Evaluation and Research at the FDA.

The time frame will depend on what is learned in the coming days, said Dr. Janet Woodcock, acting FDA commissioner. She noted: “We expect it to be a matter of day for this pause.”

The CDC’s Advisory Committee on Immunization Practices (ACIP) will meet Wednesday to review the cases of cerebral venous sinus thrombosis, and the FDA will review that analysis as it also investigates them.

“While these events are very rare, we are recommending a pause in the use of the J&J COVID-19 vaccine in order to prepare the health care system to recognize and treat patients appropriately, and to report severe events, they may be seen in people who’ve received the J&J vaccine,” said Dr. Anne Schuchat, principal deputy director of the CDC.

“This pause will also allow the CDC expert committee to review the situation. The safety of vaccines and the safety of the American people is of the utmost importance to us.”

In addition, federal authorities are alerting state health officials, pharmacies, and health care providers to evaluate and report any adverse events following vaccinations.

Of the women who developed blood clots, one died and a Nebraska woman was hospitalized in critical condition, the New York Times reported.

Of the nearly 7 million doses of the Johnson & Johnson vaccine already administered in the United States, about 200,000 were given to Michiganders, according to state data.

“The safety and health of Michiganders will always come first,” said Bobby Leddy, press secretary for Gov. Gretchen Whitmer. “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 hot spots like Michigan to slow the spread of COVID-19 and save lives. Gov. Whitmer will continue fighting for the vaccines we need to protect Michiganders, so we can get back to normal as soon as possible.”

Jeff Zients, White House COVID-19 response coordinator, said Tuesday’s 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.”

Anyone scheduled for a Johnson & Johnson vaccine will be “quickly rescheduled for a Pfizer or Moderna vaccine,” Zients said.

“Over the last few weeks, we have made available more than 25 million doses of Pfizer and Moderna each week, and in fact this week we will make available 28 million doses of these vaccines,” Zients said.

“This is more than enough supply to continue the current pace of vaccinations of 3 million shots per day, and meet the president’s goal of 200 million shots by his 100th day in office — and continue on to reach every adult who wants to be vaccinated.”

Local health officials scramble

The Johnson & Johnson pause led to a scramble among local health departments that have vaccine clinics scheduled to administer the shots.

The city of Detroit announced it has enough doses of the Moderna and Pfizer vaccines to immunize everyone who has an appointment scheduled this week for the Northwest Activities Center and neighborhood clinics.

Appointments at the TCF Center garage mass drive-thru vaccination clinic and Saturday community center clinics in Detroit are not affected because health officials have always administered Pfizer or Moderna vaccines at those sites.

The Oakland County Health Division also switched to the Pfizer vaccine at a planned clinic Tuesday for 18- to 24-year-old college students at Oakland University’s recreation center, said Bill Mullan, spokesman for County Executive Dave Coulter.

Vaccine clinics run by the Macomb, Wayne, and Ingham county health departments will switch to Moderna and Pfizer vaccines and will continue as scheduled. However, a city of Warren vaccine fair scheduled for Thursday through Sunday will be canceled, Mayor Jim Fouts said, and rescheduled “when it’s proven beyond a doubt that it is safe to do so.”

In Washtenaw County, the vaccine clinic at Pierce Lake Elementary in Chelsea will continue as scheduled using the Pfizer vaccine. However, the scheduled clinic Tuesday afternoon at the Eastern Michigan University Convocation Center is postponed. Two clinics scheduled for Wednesday at Concordia University and EMU also are postponed.

Symptoms to watch for

The Johnson & Johnson vaccine was made using a platform that has been successful in creating vaccines for Ebola and Zika viruses. It is a recombinant vector vaccine that uses a modified version of the human adenovirus, which causes the common cold, with the genetic spike protein found in SARS-CoV-2.

Marks said Tuesday that what’s different about the six U.S. women who developed this condition within six and 13 days of getting a Johnson & Johnson COVID-19 vaccine is that they also had a low platelet count, also known as thrombocytopenia.

“The combination here — the real thing that is so notable here — is not just the cerebral venous sinus thrombosis or the thrombocytopenia,” Marks said. “Those two things can occur. It’s their occurrence together that makes a pattern, and that pattern is very, very similar to what was seen in Europe with another vaccine.”

That’s AstraZeneca’s COVID-19 vacicne, which is similar to Johnson & Johnson’s in that it’s also a recombinant vector vaccine using the adenovirus from a chimpanzee.

“We don’t have a definitive cause,” Marks said. “But the probable cause that we believe may be involved here … is a similar mechanism that may be going on with other the other adeno-viral vector vaccine. That is that this is an immune response that occurs very, very rarely after some people receive the vaccine, and that immune response leads to activation of the platelets and these extremely rare blood clots.”

People who got the one-dose J&J vaccine who develop severe headache, abdominal pain, vision changes, severe nausea and vomiting, or seizures anywhere from four days to three weeks after vaccination should seek medical care, said Dr. Geoffrey Barnes, a cardiologist and vascular medicine specialist at the Michigan Medicine Frankel Cardiovascular Center.

Health care providers are asked to report adverse events to the Vaccine Adverse Event Reporting System: https://vaers.hhs.gov/reportevent.html.

Woodcock said despite the temporary pause for the Johnson & Johnson vaccine, people should continue to get COVID-19 vaccines.

“We need to reiterate we are committed to vaccination,” Woodcock said Tuesday. “We feel that is a really important tool to get this pandemic under control. We’re also committed to patient safety and our message is that in doing this, we feel we’re taking the route that will provide the most safety for patients by enabling health care professionals to recognize, to properly treat, and properly report any of the events that might happen.

“To those who haven’t been vaccinated … get the vaccines that are available to them. Because the risks from the pandemic are significant, and the government is really looking into very carefully any safety problems so that they can be managed properly with this particular vaccine and all vaccines.”

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