“We are recommending a pause in the use of this vaccine out of an abundance of caution,” the FDA said. “Right now, these adverse events appear to be extremely rare.”
Here’s how local vaccine providers have responded:
Premier Health
“The only clinic at which Premier Health was scheduled to administer the Johnson & Johnson vaccine was a student clinic tomorrow (Wednesday, April 14) held in partnership with the University of Dayton at UD Arena. That clinic has been canceled until further notice. We have paused use of this specific vaccine in accordance with federal and state guidance. All Premier Health-sponsored clinics are moving forward as we continue to administer two-dose COVID-19 vaccines.”
University of Dayton
“We have been advised of the FDA and CDC recommendation, and out of an abundance of caution in consultation with our medical advisory panel and in light of the Ohio governor’s advice to pause these vaccines, we have canceled a J&J student vaccine clinic scheduled for Wednesday,” according to a statement issued by the University of Dayton. “We are sharing information with our campus community about the federal guidance and advising them to seek medical attention if they have symptoms.”
Credit: Lynn Hulsey
Credit: Lynn Hulsey
UD had received an allocation of 2,000 Johnson and Johnson COVID-19 vaccines from the state. On Sunday UD, in partnership with Premier Health and Miami Valley Hospital, administered 1,116 the vaccines to students and a few employees at a UD Arena vaccine clinic.
Students and staff who got the vaccine Sunday “have been notified through multiple messages, and designated family members of students also will receive notification, about the pause in administration of this particular vaccine, the reason why, and the symptoms of blood clots while the FDA and CDC assess if these very rare events have any association with the vaccine,” according to a statement issued by UD Tuesday afternoon.
In a letter issued today to faculty, students and staff the University said its “medical advisory panel will continue to monitor developments in the CDC’s examination of six cases involving blood clots in the weeks following use of the Johnson & Johnson vaccine and advise you to do so as well. We will communicate substantive information as it becomes available.”
“The unique clot being investigated is called cerebral venous sinus thrombosis. It would present with severe headache, blurry vision and weakness on your face and limbs. Cases being investigated happened four to 14 days after vaccine administration,” said Dr. Steve Burdette, medical director infection prevention for Miami Valley Hospital and a member of the medical advisory.
The letter also advised students to contact the UD Student Health Center at 937-229-3131 with any questions.
“For emergencies, including severe headache, blurry vision, sudden onset of weakness, difficulty breathing or chest pain, call 911 or UD Public Safety at 937-229-2121,” the letter said.
Wright State University
Wright State University alerted students this morning that Johnson and Johnson vaccinations would pause based on the CDC and FDA recommendation, said Seth Bauguess, director of the office of communications.
He said Wright State was allotted 400 J&J doses and had administered 61 to Wright State students before the pause.
“We continue to offer a second vaccination opportunity (Moderna) to students 18 and older through Wright State Physicians: Our coronavirus website has been updated with the information too,” Bauguess said.
Students with questions or concerns about the vaccine were urged to contact Student Health Services at 937-245-7200 or their health care provider.
Wright State Physicians
“As a result of the nationwide pause Wright State Physicians student health clinic has paused it’s J&J vaccine distribution to Wright State students.
Students can schedule with Wright State Physicians to receive the Moderna vaccine, which involves two doses, if they will be available for both doses, that are 28 days apart.”
Vaccine clinics are being held on-campus weekly. Students can register for an appointment by calling 937-245-7200 or visiting http://bit.ly/WSPvaccine or www.wrightstatephysicians.org. Patients must have an appointment to be vaccinated.
Public Health - Dayton & Montgomery County:
"Public Health - Dayton & Montgomery County is suspending administration of the vaccine and pausing registration for new appointments for individuals to receive the Janssen vaccine by Johnson & Johnson. Individuals who have previously made an appointment to receive the Johnson & Johnson vaccine with Public Health, will receive further information via email or phone regarding their vaccination options.
Public Health will continue to administer the Pfizer and Moderna vaccines.
Public Health - Dayton & Montgomery County and the Ohio Department of Health are following this situation closely and will provide further guidance and information when it becomes available.”
Butler County General Health District:
“As soon as we were informed of the requested halt to use of J&J one shot vaccine, we withdrew our supply. The Johnson & Johnson vaccine will not be used at all until we hear otherwise from trusted, authoritative sources such as the CDC or ODH.”
Clark County Combined Health District
Pausing Johnson & Johnson clinics isn’t expected to have a significant impact on Clark County Combined Health District, which doesn’t receive a lot of J&J doses.
“I don’t believe we have any now, so it might very well have no impact at all,” Kyle Trout, spokesman for the health district said.
Champaign Urbana Public Health District
Champaign Urbana Public Health District hasn’t been receiving a lot of Johnson & Johnson shots lately said Health Commissioner Gabe Jones. However, some of the health district’s partners have received the vaccine.
“We are monitoring the situation closely,” Jones said. “For those who have received the vaccine from us, these events are extremely rare. We have not had any type of adverse event reported to us at this time out of thousands of doses given.”
State officials recommend pause
Today Go. Mike DeWine, Ohio Department of Health Director Stephanie McCloud, and Ohio Department of Health Chief Medical Officer Dr. Bruce Vanderhoff are advising all Ohio vaccine providers to temporarily pause using the Johnson & Johnson vaccine.
Credit: JIM NOELKER
Credit: JIM NOELKER
The Food and Drug Administration and CDC is recommending a pause in the use of the Johnson & Johnson vaccine following extremely rare blood-clotting events of six people in the U.S. who had received the vaccine.
In addition, the CDC will convene a meeting of the Advisory Committee on Immunization Practices tomorrow to further review these cases.
The full statement from the CDC and FDA is available below:
As of April 12, more than 6.8 million doses of the Johnson & Johnson (Janssen ) vaccine have been administered in the U.S. CDC and FDA are reviewing data involving six reported U.S. cases of a rare and severe type of blood clot in individuals after receiving the J&J vaccine. 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). All six cases occurred among women between the ages of 18 and 48, and symptoms occurred 6 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.
CDC will convene a meeting of the Advisory Committee on Immunization Practices (ACIP) on Wednesday to further review these cases and assess their potential significance. FDA will review that analysis as it also investigates these cases. Until that process is complete, we are recommending a pause in the use of this vaccine out of an abundance of caution. This is important, in part, to ensure that the health care provider community is aware of the potential for these adverse events and can plan for proper recognition and management due to the unique treatment required with this type of blood clot.
Right now, these adverse events appear to be extremely rare. COVID-19 vaccine safety is a top priority for the federal government, and we take all reports of health problems following COVID-19 vaccination very seriously. People who have received the J&J vaccine who develop severe headache, abdominal pain, leg pain, or shortness of breath within three weeks after vaccination should contact their health care provider. Health care providers are asked to report adverse events to the Vaccine Adverse Event Reporting System at https://vaers.hhs.gov/reportevent.htmlexternal icon.
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