Allen County Public Health officials have halted the use of the Johnson & Johnson vaccine at its mass vaccination site, where more than 2,600 doses of the now-paused vaccine have been administered since late March.
They were joined by Ohio Northern University officials, who stopped the use of the Johnson & Johnson vaccination program in Hardin, Logan and other rural counties, but will resume vaccinations with Moderna on Thursday.
Their decisions followed a request by federal health officials urging a nationwide pause in the use of Johnson & Johnson’s COVID-19 vaccine.
In a joint statement early Tuesday morning, the Centers for Disease Control and Prevention and the Food and Drug Administration said they were investigating clots in six women between the ages of 18 and 48 who developed a “rare and severe” blood clot called cerebral venous sinus thrombosis six to 13 days after receiving a Johnson & Johnson vaccine. One woman died and another is in critical condition.
The pause is only for the Johnson & Johnson vaccine.
Moderna and Pfizer vaccinations — the most widely used COVID-19 vaccines in the U.S. — will continue uninterrupted, as the rare blood clotting issues have not been observed in individuals who received either mRNA vaccine. Pfizer and Moderna vaccines are made with a completely different technology, and the FDA said there is no sign of a similar clot concern with those vaccines.
Dr. Susan Koletar, an infectious disease specialist for Ohio State University’s Wexner Medical Center, said on Tuesday that the clotting appears related to a rare autoimmune event in which the body attacks the blood platelets.
Signs of an adverse reaction include persistent nausea or vomiting, severe headaches, change in vision, shortness of breath and swelling or pain in lower extremities, said Columbus Health Commissioner Dr. Mysheika Roberts.
The clots were observed in the sinuses of the brain along with reduced platelet counts — making the usual treatment for blood clots, the blood thinner heparin, potentially “dangerous.”
Officials said the pause may last only a few days, depending on what they learn in their review of medical data, and that it’s possible they will adjust their guidance on the best candidates to receive the Johnson & Johnson vaccine — for example, by age group. The CDC has scheduled an emergency meeting for Wednesday, and officials promised to move quickly.
“Until that process is complete, we are recommending a pause in the use of this vaccine out of an abundance of caution,” Dr. Anne Schuchat, principal deputy director of the CDC, and Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, said in a joint statement.
They are recommending that people who were given the J&J vaccine who are experiencing severe headache, abdominal pain, leg pain, or shortness of breath within three weeks after receiving the shot contact their health care provider.
Officials say they also want to educate vaccine providers and health professionals about the “unique treatment” required for this type of clot.
What makes these clots different is they’re occurring in unusual parts of the body, such as veins that drain blood from the brain. Second, those patients also have abnormally low levels of platelets — cells that help form clots — a condition normally linked to bleeding, not clotting.
Health officials said one reason for the J&J pause was to make sure doctors know how to treat patients suspected of having these clots, which includes avoiding giving heparin.
Anne Schuchat, principal deputy director of the CDC, said people should continue to get inoculated with the Pfizer or Moderna vaccines when an appointment is available, although she admitted that the process “may be a bit bumpy” as some appointments are rescheduled.
The officials in Tuesday’s briefing emphasized that reports of serious blood clots are extremely rare. They said people who received a Johnson & Johnson vaccine in recent weeks should contact their healthcare provider if they experience severe headaches, abdominal pain, leg pain or shortness of breath.
Unlike the Pfizer and Moderna vaccines, the Johnson & Johnson version requires only one shot and does not need to be stored at extremely cold temperatures, making officials optimistic that it could be administered and transported more easily. Roughly 7 million Americans have already received a dose of the Johnson & Johnson vaccine.
Allen County Public Health had already scaled back its mass vaccination program at the former Knights of Columbus hall due to low demand when the health department on Tuesday canceled its only two Johnson & Johnson clinics for the week.