State halts use of J&J COVID-19 vaccine
Rare adverse side effect federally investigated
The Wisconsin Department of Health Services is telling vaccine providers not to administer the Johnson & Johnson shot while federal health authorities investigate an extremely rare but severe blood-clotting reaction.
Providers should keep the vaccine until a federal review has been completed, DHS secretary-designee Karen Timberlake said in a Tuesday statement.
Earlier Tuesday, federal health officials recommended an immediate halt to injections of the single-dose vaccine after six people in the U.S. developed a blood-clotting condition known as cerebral venous sinus thrombosis within two weeks of being vaccinated.
One woman died and one has been hospitalized in critical condition, The New York Times reported. All six cases were women between the ages of 18 and 48.
The adverse effects “appear to be extremely rare,” according to a joint statement issued by leaders at the Food and Drug Administration and Centers for Disease Control. The recommended pause was issued “out of an abundance of caution,” they said.
Nearly 7 million doses of the Johnson & Johnson vaccine have been administered across the country, the vast majority of them without incident.
Wisconsin has administered more than 156,000 doses, according to state data — accounting for 4% of the total doses given in the state so far. Out of about 170,000 doses received by the
state this week, 10,200 were Johnson & Johnson doses.
Wisconsin’s short-term rollout likely won’t be impacted much by the Johnson & Johnson news, DHS interim health officer Julie Willems Van Dijk told reporters in a press briefing. State health officials were expecting about 3,000 doses of the shot next week compared with hundreds of thousands of Pfizer and Moderna vaccines, she said.
None of the six cases of cerebral venous sinus thrombosis occurred in Wisconsin to the state’s knowledge, Van Dijk said.
She said people should be reassured, not scared, by the pause, because it’s evidence that the CDC’s system for monitoring adverse health effects related to the vaccine is working as it should.
With less than one in a million people who received a Johnson & Johnson vaccine developing the reaction, Van Dijk said, Wisconsinites who got it should know it’s extremely unlikely to happen to them.
If you received the Johnson & Johnson shot recently, be on the lookout for a severe headache, abdominal pain, leg pain, shortness of breath or new vision problems between six and 15 days after you got the vaccine. Those could be signs of a more serious issue, Van Dijk said.
Flu-like side effects a day or two after receiving the shot are normal and not cause for concern.
Even before the state health department’s instruction to halt administration of the Johnson & Johnson vaccine, many health systems had announced a pause Tuesday morning.
The federal guidance created an immediate disruption at Prevea Health, which on Tuesday had Johnson & Johnson appointments scheduled at both of its Green Bay clinics and several others throughout the state. A spokesperson for the system said it would try to switch people signed up for those appointments to Pfizer or Moderna.
That was also the approach at ThedaCare, where 250 doses of the Johnson & Johnson vaccine were scheduled to be administered in two clinics this week. Walgreens, Advocate Aurora Healthcare, Froedtert and the Medical College of Wisconsin all likewise said they’d offer other vaccines to patients scheduled to receive Johnson & Johnson.
Milwaukee County Executive David Crowley said the county would pause its administration of the vaccine at the Kosciuszko Community Center, the county’s Franklin-based House of Correction and the Milwaukee County Jail.
He said not using the vaccine would affect the county’s vaccination efforts but “does not pause our efforts completely.” The county will continue to administer the Moderna vaccine, he said.
Several suburban Milwaukee health departments had planned to administer hundreds of Johnson & Johnson doses at clinics this week, including Cudahy, Oak Creek, South Milwaukee, St. Francis, Greenfield, Hales Corners, Greendale, Franklin, Wauwatosa and West Allis, all of which are now on hold as they ask people to cancel and reschedule for a Pfizer or Moderna clinic.
Waukesha County Public Health identified 123 people who received the Johnson & Johnson vaccine at its community vaccination clinic within the last three weeks. Tuesday, and the department called and emailed those people to tell them to contact their doctors if they experience specific health symptoms. The department doesn’t have any Johnson & Johnson vaccine currently.
At Aspirus, where only 3% of total doses administered so far had been Johnson & Johnson, pharmacy director Jill Michaud said no appointments would need to be canceled because of the pause. The vaccine has made up a similarly small fraction of total doses delivered by Marshfield Clinic, Froedtert and Advocate Aurora.
Health systems offered reassurance to patients who recently received the shot. At Bellin Health, which wasn’t scheduled to administer any Johnson & Johnson doses this week at its mass vaccination site at Lambeau Field, a spokesperson said they’re telling concerned callers that the complications are extremely rare.
Agnesian, which delivered 2,000 Johnson & Johnson shots at a clinic in Fond du Lac last Saturday, said people with concerns should contact their doctor. Marshfield Clinic administered nearly 700 doses at a clinic at UW-Stevens Point last weekend and will answer questions from people who have them, a spokesperson said.
If you received the Johnson & Johnson shot recently, be on the lookout for a severe headache, abdominal pain, leg pain, shortness of breath or new vision problems between six and 15 days after you got the vaccine.
Johnson & Johnson shots have been delivered all across the state, Van Dijk said, many of them to local health departments. Both Kewaunee and Oconto counties in northeast Wisconsin canceled upcoming vaccine clinics due to the news.
A CDC advisory committee will hold a meeting Wednesday to analyze the blood clot cases. The FDA said it will review the committee’s analysis as it also investigates the cases. The review is expected to be completed quickly, in a matter of days, health officials said.
The Johnson & Johnson vaccine and the AstraZeneca vaccine, which has been approved in Europe but not yet in the U.S., are made with the same technology, and the AstraZeneca shot has also caused rare instances of a clotting disorder.
European officials have concluded the clots are similar to a very rare immune response that sometimes affects people treated with the blood-thinner heparin. CDC and FDA officials are cautioning doctors against using heparin to treat blood clots caused by the vaccine.
Neither the Pfizer or Moderna vaccine have produced this blood-clotting reaction, said DHS chief medical officer Ryan Westergaard, and people should feel comfortable continuing to receive them as the Johnson & Johnson reactions are investigated.
While the chances of developing a blood clot associated with the J&J vaccine may be less than one in a million, some studies have shown the chances of developing a blood clot from COVID-19 could be as high as 31% for critically ill coronavirus patients in intensive care.
Allison Garfield, Benita Mathew, Alan Hovorka, Sharon Roznik, Mark Johnson, Mary Spicuzza, Evan Casey and Alison Dirr contributed to this story.