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5 Questions About the Johnson & Johnson Vaccine Pause

April 13, 2021

The Food and Drug Administration and the Centers for Disease Control and Prevention asked states Tuesday to immediately pause use of Johnson & Johnson’s single-dose COVID-19 vaccine after six recipients developed a rare blood-clotting disorder.

Here are five questions about the pause:

How Long Will The Pause Last?

FDA and CDC scientists will examine possible links between the vaccine and the rare blood-clotting disorder. An emergency meeting of the CDC’s Advisory Committee on Immunization Practices is scheduled Wednesday. The pause probably will last “more like days to weeks than weeks to months,” said Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, at an afternoon briefing.

Will the Pause Affect Hartford HealthCare’s Vaccination Efforts?

The Johnson & Johnson vaccine represents only a small percentage of vaccinations administered by Hartford HealthCare:

• Pfizer: 236,370 doses (combined first and second).
• Moderna: 75,971 doses (combined first and second).
• Johnson & Johnson: 18,857 doses.

“This does not significantly impact our overall vaccine administration,” said Dr. James Cardon, Hartford HealthCare’s Chief Clinical Integration Officer. “We were predominantly administering the mRNA (Pfizer and Moderna) vaccines, given the recent reduction in allocation of the J&J.”

Dr. Cardon said the Johnson & Johnson vaccine had been used in a new pilot project that vaccinated patients leaving acute-care facilities and the Emergency Department. Hartford HealthCare also planned to use the Johnson & Johnson vaccine for a mobile vaccination site, said Dr. Cardon, “where we had a very small number of folks signed up.”

For now, those sites will use the Pfizer and Moderna vaccines. Safety comes first in both the development and distribution of any vaccine.

“It’s extremely reassuring that we picked up six events in 6.85 million doses,” said Dr. Cardon, “with enough sensitivity to find those six events, to call them out and say hit the pause button tells me we are focused on the very high bar of trying to make sure that when we’re vaccinating somebody that it’s safe.”

What Is Different About Blood Clots in These Cases?

Six people, all women between ages 18 and 48, among the close to 7 million in the United States who received the Johnson & Johnson vaccine developed the rare blood-clotting disorder. One woman died and another remains hospitalized in critical condition.

Doctors typically use heparin, an anticoagulant drug, to treat blood clots. The FDA and CDC, however, said “administration of heparin may be dangerous, and alternative treatments need to be given.”

Each year, 300,000 to 600,000 people in the United States develop blood clots, according to the CDC. The blood-clotting disorder developed by the vaccine recipients is extremely rare.

Dr. Ulysses Wu, Hartford HealthCare’s System Director of Infection Disease and Chief Epidemiologist, said the vaccine could cause a low platelet level, a condition called thrombocytopenia, rather than the more typical venous sinus thrombosis that occurs unrelated to the vaccine.

“With their pause,” he said, “they’re trying to establish causality and, obviously, whether or not there are any safety issues associated with this.”

What Are The Symptoms of This Rare Disorder?

If you’ve had a Johnson & Johnson vaccine in the past three weeks and develop a severe headache, abdominal pain, leg pain or shortness of breath, call your doctor.

Could Some States Still Use the Vaccine?

Theoretically, yes. The FDA and CDC, which will stop using the vaccine at federal sites, recommended states temporarily halt its use. The FDA did not withdraw the vaccine’s emergency use authorization. The state Department of Public Health quickly approved of the recommendations, as did Hartford HealthCare, which announced shortly after a joint FDA-CDC statement that it would immediately halt use of the vaccine.

“I do believe this is right thing to do at this point with this medication,” said Keith Grant, APRN, Hartford HealthCare’s Senior Director of Infection Prevention. “There are a number of medications that have an increased risk of blood clots, but how they deal with those are different from this. So we understand why this has been dealt with this way.”