The Nebraska Department of Health and Human Services and the Douglas County Health Department said Tuesday that they are temporarily suspending use of Johnson & Johnson’s COVID-19 vaccine in the wake of federal officials’ call for a pause in its use.
In a joint statement Tuesday, the federal Centers for Disease Control and Prevention and the Food and Drug Administration recommended the pause “out of an abundance of caution.” The recommendation was based on six reported cases in the United States of a rare and severe type of blood-clotting condition. All six cases occurred in women between ages 18 and 48, the CDC and FDA said, with symptoms appearing six to 13 days after vaccination.
State officials said Tuesday that representatives from the State HHS, the Douglas County Health Department and Nebraska Medicine consulted with officials from the CDC and FDA on Thursday about a rare and severe type of blood clot diagnosed in a Douglas County resident. Officials noted that the reports of blood clots in the six women were out of approximately 6.8 million Americans who have received the J&J vaccine.
State officials are informing local health departments, health care providers and pharmacies across Nebraska about the decision. Late Tuesday morning, the Sarpy/Cass Health Department and the Lincoln-Lancaster County Health Department issued statements saying they were pausing administration of the J&J vaccine.
Iowa health officials announced that they, too, had advised that all Iowa vaccine providers pause administration of the J&J vaccine.
The CDC on Wednesday will convene a meeting of the Advisory Committee on Immunization Practices to review the cases and assess their potential significance. The FDA will review the analysis as it also investigates the cases.
Dr. Janet Woodcock, the acting commissioner of the FDA, said during a press conference Tuesday that the pause was expected to last only “a matter of days,” although she said the time frame depends on “what we learn in the next few days.”
The pause comes against the backdrop of rising COVID cases in some parts of the country and an increase in more contagious COVID-19 variants.
Woodcock said federal health officials were taking the step — and doing it quickly — because of the need to alert the public and to prepare health care providers to diagnose, treat and report the rare condition.
The cases involve a type of blood clot called cerebral venous sinus thrombosis combined with low levels of blood platelets.
Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, said treatment for the condition is different from the standard treatment for blood clots, which involves giving blood thinners. With this condition, that treatment can cause harm — or death. Officials said one of the six women identified with the condition has died.
Health care providers, Marks said, need to know that if they see patients with blood clots or low platelet levels, they should ask whether they recently were vaccinated and, if so, take the appropriate steps to treat them.
Dr. Anne Schuchat, principal deputy director of the CDC, said Tuesday that federal health officials are not seeing any clotting issues arise with the Pfizer and Moderna vaccines, which make up the bulk of shots given in the United States.
People with appointments to get those vaccines should go ahead and get them, she said.
For those who have gotten the J&J vaccine a month or more ago, she said, the risk of the complications is very low. Those who have gotten the J&J shot recently should contact a health care provider if they experience severe headache, abdominal pain, leg pain or shortness of breath. Those symptoms differ from the mild, flu-like symptoms most people experience after getting the vaccines.
Marks said that the occurrence of clots and low platelet levels in combination stood out as a pattern. That pattern is “very, very similar” to what was seen in Europe with another vaccine.
While Marks did not name the vaccine, AstraZeneca’s COVID-19 has been associated with rare blood clotting events. Some European countries have restricted its use in older people.
Both the J&J and AstraZeneca vaccines are based on a similar platform, using harmless viruses called adenoviruses to carry information into the body to teach the immune system to recognize and respond to COVID-19.
Woodcock said the leading theory is that people who are vaccinated may, in rare cases, have an immune response that involves their own platelets or other blood-clotting mechanisms.
The Pfizer and Moderna vaccines, the other two shots currently available in the United States, are based on a different technology.
Dr. Mark Rupp, chief of the University of Nebraska Medical Center’s infectious diseases division, said Tuesday that he thinks it’s appropriate to pause and take a closer look at the new information regarding the vaccine.
Depending on the federal agencies’ findings, that could result, as it has in Europe, in limiting use of the vaccine among certain groups.
However, Rupp said he is concerned that the pause could reinforce vaccine hesitancy in some people.
“We need to steer a course between being careful ... and not overreacting to the potential rare side effects,” he said.
Adi Pour, the Douglas County Health Department’s director, said the department may have to cancel a smaller vaccination clinic, but it appears the department will have enough vaccine to move ahead with current plans.
The county had planned to give 4,000 doses of J&J vaccine this week. All of those with appointments have been notified that the department will switch to Moderna. About 10 people said they would wait because they are interested in getting the single-dose J&J vaccine.
The J&J doses on hand, she said, are safely stored and won’t expire until mid-June. That should allow plenty of time for federal officials to reach a conclusion.
Nebraska Gov. Pete Ricketts had said on Monday that he would not suspend use of the J&J vaccine statewide following reports of a Douglas County resident developing blood clots about two weeks after receiving the vaccine. Ricketts stressed that all the vaccines are safe and effective and that Nebraskans are at greater risk from COVID-19 than they are from some of the side effects of the vaccine.
The Douglas County case was reported Friday. Monday, the person, who is in her late 40s, remained in “guarded condition” at the Nebraska Medical Center, state health officials said.
Among the 40,000 people participating in the trials of the J&J vaccine, blood clots were reported in 14 vaccinated people, or .06% of those who got the vaccine. Among those who got a placebo, 10 reported blood clots, or a rate of .05%.
Dr. Brett Giroir, an assistant U.S. Health and Human Services secretary during the Trump administration, said Tuesday on Twitter that the pause is an appropriate step while the data is being evaluated. “Such clots occur regularly in the population, so this MAY or MAY NOT be related to the vaccine. That is why the investigation and pause is appropriate.”
Nebraska officials stressed that no recommendations had been made to pause the use of the other two vaccines, Pfizer and Moderna. Those two vaccines, officials said, should be provided in place of the J&J vaccine until further notice.
As of Friday, more than 31,700 doses of the J&J vaccine had been administered in Nebraska. More than 4.5 million of the shots had been given nationwide.