Halt of J&J vaccine tied to concern about treating blood clot patients

HARRISBURG — Pennsylvania acting Physician General Dr. Denise Johnson on Tuesday pointed to concerns about treatment of blood clot patients as a key factor in federal recommendations for a temporary stoppage of Johnson & Johnson COVID-19 vaccine shots.

Johnson’ s take echoed language in a joint statement issued earlier in the day by the U.S. Centers for Disease Control and Prevention and the Food and Drug Administration, supporting a temporary halt.

Johnson, speaking specifically about blood clot patients who got the vaccine, said, “I believe that the CDC and FDA came out to put a pause on this so that we could really evaluate what is going on here and to also make sure that providers, when they see these patients, are treating them appropriately.”

Her statements came at a news conference with acting Health Secretary Alison Beam.

Beam’s department Tuesday directed vaccine providers around the state to “pause” use of the Johnson & Johnson vaccine until at least April 20.

But Beam urged Pennsylvanians to move forward with seeking and getting COVID-19 vaccinations with the two other, approved vaccines. The temporary stoppage, Beam said, shows that the federal process to oversee the safety of the vaccines is working.

“We have said these vaccines would be the most scrutinized, and watched, vaccines ever in history. And this step reflects this,” Beam said. “The action today reflects the federal government’s commitment to protect Americans.”

Two-week focus

The federal recommendation was rooted in six instances of women aged 18 to 48 who received the shot and suffered the rare and severe blood clots six to 13 days later.

In a recent special initiative, Pennsylvania vaccinated teachers, school staffers and child care workers with the Johnson & Johnson vaccine.

The acting physician general, asked by a reporter if recipients should be concerned, focused on the two-week post-shot time period in which issues arose.

“The people who have been vaccinated, well past that time, we haven’t seen those cases,” Johnson said. “So there shouldn’t be worry for people who have been vaccinated more than that time. And if it’s been less than two weeks and those severe symptoms do occur, they should seek their health care provider.”

Low platelet levels

Beam said preliminary information indicated none of the six blood clot cases was in Pennsylvania.

She said 6.8 million people nationwide have received the Johnson & Johnson single-dose vaccine, so the rate of concerning situations is “1 in a million people.”

Johnson said blood clots occur more often than in 1 in a million people, but “the thing that is really concerning is that these blood clots are occurring with low platelet levels, and that is not something we see very commonly.”

The statement from the federal agencies said that in the six cases, a clot called “cerebral venous sinus thrombosis” appeared in combination with low levels of blood platelets. Treatment in such a situation is different than with typical blood clots, the agencies said.

“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 statement said.

The CDC is expected to hold a meeting involving immunization experts Wednesday to review the situation, and the FDA also is investigating the cases.

“Until that process is complete, we are recommending a pause in the use of this vaccine out of an abundance of caution,” the agencies’ statement said. “This 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.”