The blood-clotting issue raised by Johnson & Johnson’s COVID-19 vaccine is severe, but it’s not something most people will have to deal with, an Ohio State University expert says.
Dr. Susan Koletar, the director of OSU’s division of infectious diseases at the Wexner Medical Center, explained the situation during Ohio Gov. Mike DeWine’s briefing Tuesday, saying that research shows that major side effects from the Johnson & Johnson (J&J) vaccine are rare.
She said that the medical community speculates that the reaction is an autoimmune event in which “the body is sort of attacking the platelets.”
Platelets are tiny blood cells that bond to stop the bleeding when parts of the body are damaged, according to research at Johns Hopkins Medicine.
The Centers for Disease Control and Prevention (CDC) and the Food and Drug Administration (FDA) announced early Tuesday that the J&J vaccine, which received emergency use authorization for adults in February, caused severe blood clots in six women six to 13 days after vaccination. In the U.S., 6.8 million people have received the J&J vaccine thus far, including 264,311 people in Ohio.
“There’s a lot of thought and work being done, probably as we speak, looking at specific immune reactions or autoimmune reactions that occur and affect the platelets, which allow blood to clot,” Koletar said. “And it’s an interesting and rare event where there’s situations where the platelets are low but there’s still all this clotting. The clots that have been seen have been more rare than others.”
The CDC recommended temporarily pausing distribution of the J&J vaccine to allow the agency time to review the data and provide education to health providers and vaccine administrators because the rare vaccine-induced blood clots must be treated differently from traditional blood clots.
“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,” the CDC said. “(Pausing distribution) 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.”
Like many other states, both Ohio and Kentucky have paused administering the J&J vaccine.
Hamilton County is administering 45,000-50,000 doses of COVID-19 vaccine per week, but only about 5,000-7,000 of those are from J&J. Greg Kesterman, public health commissioner for Hamilton County, said that the pause likely would not affect the county’s goal of vaccinating 80% of the population by July 4.
OSU’s Koletar said that vaccines like J&J’s go through clinical trials before being authorized, and data from those trials did not give cause for concern.
“If you’re talking six out of 6.8 million (cases of severe blood clotting), it’s not unusual to think you’d have zero out of 44,000 (clinical trial participants),” Koletar said. “I really think it’s a tribute to the system of reporting an adverse event and a tribute to doctors and practitioners out there who are giving these vaccines to recognize these and to make sure that they’re reported.”
Dr. Bruce Vanderhoff, chief medical officer for the Ohio Department of Health, agreed that national and local safety monitoring systems are working as designed.
“The bottom line is that these cases appear to be extremely rare,” Vanderhoff said. “The fact that the CDC and the FDA have raised concerns and pushed the pause button on the basis of these six cases should give Ohioans great confidence in not only the priority that is being placed on vaccine safety, but also the reliability and transparency of the CDC’s and FDA’s safety monitoring systems. Today’s announcement really shows that that system works and works well.”
During the April 13 briefing, DeWine said that Ohio has mostly administered Pfizer and Moderna COVID-19 vaccines, which received emergency use authorization for adults in December. Pfizer currently is seeking additional authorization for adolescents ages 12-15.
The J&J vaccine largely has been used at mass vaccination sites for students, DeWine said. Unlike the Pfizer and Moderna vaccines that require two doses several weeks apart, the J&J vaccine needs only a single dose, making it effective for college students, people without homes, people who are in corrections facilities, minority groups and people who are less likely to return for a second dose of the other vaccines.
DeWine said that the state’s recent push to vaccinate college students will be affected, but many of the institutions already have completed their vaccination schedules. Those that haven’t will pause J&J vaccination or will use alternatives.
“Sixty-three public and private four-year institutions received vaccinations. The good news is that many of them finished that vaccination last week. There are some, however, that did not finish it, and they are now paused,” DeWine said. “The larger universities are the ones who could not complete that last week, and many of them were continuing this week as well as in the next several weeks. Well, that was the plan.”
Dr. Andrew Thomas, chief medical officer at OSU’s Wexner Medical Center, said that Ohio State has administered at least 100,000 doses of COVID-19 vaccine on campus.
“We’ve found the vaccines overall to be very safe and well tolerated. We remain very supportive of the concept that vaccination is a key critical part of working our way through this pandemic,” Thomas said during the briefing. “Obviously masking and distancing are still important, and avoiding large crowds where you can’t control your environment is still very important to reduce cases today.”
Mass vaccination sites and college/university vaccination sites currently using J&J vaccines will switch to Pfizer and Moderna or will pause operations. In Cincinnati, the University of Cincinnati’s on-campus student clinic will begin using Pfizer and the large-scale mass public vaccination site at the Cintas Center will pause, according to available information. A full list of the changes is available on Ohio’s coronavirus dashboard.
According to April 13 figures on the coronavirus dashboard, Ohio has had a total of 1,043,729 confirmed and probable COVID-19 cases, 54,334 hospitalizations and 7,562 intensive care unit admissions.
The state is at 183.7 cases per 100,000. DeWine has said that the state would lift all COVID-19 safety restrictions once Ohio reaches 50 cases per 100,000. DeWine’s target to hit that number is July 4.
More than half of Ohio’s counties have seen increases in COVID-19 cases recently, and the coronavirus’s variants are becoming a greater concern.
J&J has responded to concerns about its vaccine, as reported by ABC News.
"We are aware that thromboembolic events including those with thrombocytopenia have been reported with COVID-19 vaccines," says the corporation. "At present, no clear causal relationship has been established between these rare events and the Janssen COVID-19 vaccine. We continue to work closely with experts and regulators to assess the data and support the open communication of this information to healthcare professionals and the public."
The CDC asks health care providers to report adverse events to the Vaccine Adverse Event Reporting System at vaers.hhs.gov/reportevent.html.