J&J halt for blood clot investigation disrupts Ohio

On Apr 13, 2021

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.

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.”

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 of 4/12, 6.8m+ doses of the J&J vaccine have been administered in the U.S. CDC & FDA are reviewing data involving 6 reported U.S. cases of a rare & severe type of blood clot in individuals after receiving the vaccine. Right now, these adverse events appear to be extremely rare

— U.S. FDA (@US_FDA) April 13, 2021

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.