OHIO — Vaccine clinics at Ohio’s college campuses are in limbo Tuesday after the U.S. government ordered a pause on administration of the Johnson & Johnson COVID-19 vaccine due to blood clot concerns.
Ohio is using its allocation of J&J toward its goal of immunizing every college student who wants a shot before summer break.
State officials confirmed Tuesday that all Ohio providers were being advised to halt administration. A statement from the governor’s office said they were following the situation closely.
Some Ohio colleges have already announced they're halting distribution. Kent State, Case Western Reserve University and the University of Dayton announced Tuesday all clinics scheduled to distribute the J&J vaccine are postponed until further notice.
Public health departments are reaching out to people who made appointments for the J&J vaccine. The public health department of Dayton and Montgomery County said Tuesday individuals will receive information either through email or by for other vaccination options. The health department will continue to distribute Pfizer and Moderna.
Cleveland Clinic said Tuesday it has vaccinated 1,800 individuals with the J&J vaccine and have not received any reports of blood clots.
"We do not anticipate that this pause will affect our vaccination program. We will continue to follow the guidance of the FDA and CDC as they complete their review," the Cleveland Clinic said.
Prior to the development Tuesday morning, Gov. Mike DeWine told Spectrum News at a media briefing in Athens, Ohio Monday afternoon that he remains confident in the J&J vaccine.
Last week, J&J clinics in North Carolina, Georgia, Iowa, and Colorada, were paused due to safety investigations.
“Well, all we can do is go by what the experts tell us, and what they tell us is that they have confidence in the Johnson & Johnson, and so we follow what the experts are saying,” DeWine said, after he watched three college students at Ohio University roll up their sleeves for J&J.
The Federal Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC) issued a statement Tuesday recommending the immediate halt of J&J vaccine distribution after six people developed a rare disorder called cerebral venous sinus thrombosis that involves blood clots out of the 6.8 million doses administered so far.
All six of the people who developed the disorder were women and developed the condition around three weeks after receiving a dose, according to health officials.
While health experts are worried the vaccine may have triggered their immune systems in such a way to develop the disorder, J&J said there’s no correlation.
“We are aware that thromboembolic events including those with thrombocytopenia have been reported with COVID-19 vaccines. At present, no clear causal relationship has been established between these rare events and the Janssen COVID-19 vaccine,” J&J wrote in a news release Tuesday.
Although the adverse effects are “extremely rare,” the FDA and CDC said the recommendation is out of “an abundance of caution.”
Jeff Zients, the White House COVID-19 Response Coordinator, wrote in a statement Tuesday that the news won't impact the White House's vaccination goals. Zients said the J&J vaccinations account for less than 5% of total COVID-19 vaccinations in the U.S.
Dr. Anne Schuchat, the CDC principal deputy director, said the situation developed rapidly and there was not much time to discuss the matter with the states before announcing the pause to the public.
The United States has secured enough Pfizer and Moderna doses for 300 million Americans," Zients said. "Over the last few weeks, we have made available more than 25 million doses of Pfizer and Moderna each week, and in fact this week we will make available 28 million doses of these vaccines. This is more than enough supply to continue the current pace of vaccinations of 3 million shots per day, and meet the President’s goal of 200 million shots by his 100th day in office — and continue on to reach every adult who wants to be vaccinated."
The supply of J&J in the U.S. has dropped off due to a manufacturing error at a facility in Baltimore. DeWine said Monday the supply of J&J has “crashed.” The week of April 12, Ohio was allocated just 20,300 J&J doses, down from 171,900 the week of April 5, and 67,400 the week of March 29, according to the CDC.
As a single-shot vaccine, J&J was ideal for vaccinating college students in time for graduations and other end of the year activities, DeWine said.
The FDA will hold a press conference later Tuesday morning to update the public on any developments.
The CDC will convene a meeting of the Advisory Committee on Immunization Practices (ACIP) on Wednesday to review these cases, but until that happens, the agencies are recommending the pause.
“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.
U.S. officials said the adverse events with this type of blood clot may require unique treatment.
"This is important to ensure that the health care provider community is aware of the potential for these adverse events and can plan due to the unique treatment required with this type of blood clot," the officials said.