The Iowa Department of Public Health has advised all vaccine administrators in the state to temporary cease using the one-shot Johnson & Johnson following a joint statement on Tuesday morning from the CDC and FDA calling for “a pause in the use of this vaccine.”
The CDC and FDA called for the pause in response to six cases involving a rare type of blood clot out of the approximately 6.8 million doses of the J&J vaccine. All six cases occurred among women between the ages in 18 and 48 who had received the vaccine between six and 13 days earlier. One of the six women died, and another is currently hospitalized in critical condition.
The type of clotting involved is known as cerebral venous sinus thrombosis (CVSP), in which blood clots prevent blood from draining out of the brain, producing stroke-like symptoms. In addition to CVSP, all six patients also experienced low levels of platelets, the blood cells involved in clotting.
On a Tuesday morning call with reporters, Dr. Peter Marks, director of the FDA Center for Biologics Evaluation and Research, said “that pattern is very, very similar to what was seen in Europe with another vaccine.”
Although he didn’t name the vaccine, Marks was referring to the AstraZeneca vaccine, which is used widely outside the United States. As of last week, there had been 169 cases of CVSP with a low platelets count among the approximately 34 million people who have received the vaccine. One person in Austria died after developing CVSP.
“I think we have to take the time to make sure we understand this complication and we address it properly,” Marks said, explaining why the two federal agencies called for the pause.
The CDC Advisory Committee on Immunization Practices is scheduled to meet on Wednesday to review the six cases and consider next steps. On the call with reporters, Dr. Anne Schuchat, the principal deputy director of the CDC, said the decision on the next steps is expected to be made within the next few days.
While that process is going on, the FDA will be distributing new advisory material on the J&J vaccine.
“The FDA will revise the fact sheet for healthcare providers administering vaccines and the fact sheet for recipients and caregivers for the [J&J] COVID-19 vaccine to include this adverse effect information, to ensure that healthcare providers are able to make appropriate benefit/risk determinations for their patients,” Marks said.
The revision is important because only a small subset of doctors are familiar with how to treat CVSP, and the most commonly used drug to treat other forms of blood clots can cause severe adverse consequences in a patient with CVSP.
In Iowa, the Reynolds administration had directed most of the state’s supply of J&J vaccine to company-run vaccination programs for workers in “food processing, ag production as well as manufacturing and distribution companies.” The governor announced last week that because those programs were winding down, the state would prioritize providing the one-shot vaccine to colleges and universities to facilitate vaccinating students and staff before the end of the semester.
Both Iowa State University and the University of Northern Iowa have canceled vaccine clinics scheduled for this week that were going to use the J&J vaccine. The University of Iowa did not have a clinic scheduled. UI is in the process of the conducting a survey of students and staff to determine if such a clinic is necessary.
Linn County Public Health canceled a Tuesday vaccine clinic hosted by Hy-Vee and Collins Aerospace that would have used the one-shot vaccine. LCPH said people who have appointments scheduled for Tuesday will be rescheduled for vaccination.
During the phone call, both Marks and Schuchat stressed how rare developing the blood clot is — fewer than one case in a million vaccinations have been documented so far — and that their agencies were acting “our of an abundance of caution” (a phrase both used more than once). Schuchat did advise, however, anyone who has had the J&J vaccine in the past 30 days and is experiencing “severe headaches, abdominal pain, leg pain or shortness of breath” to seek medical treatment.
Most people who experience a reaction to the shot will have mild flu-like symptoms and possibly a fever. Those are not considered serious complications.