State Wants Pause in Johnson & Johnson Vaccine

The Wisconsin Department of Health Services is instructing vaccine providers in the state to stop administering the Johnson & Johnson COVID-19 vaccine.

The Centers for Disease Control and Prevention and the Food and Drug Administration recommend a “pause” in the use of the vaccine, which is a single-dose, to investigate reports of potentially dangerous blood clots. The federal and state agencies said the request is out of an “abundance of caution.”

The FDA and CDC are reviewing six reports of a rare and severe blood clot found in women in the United States in the days after being vaccinated, in combination with reduced platelet counts. As of Monday, more than 6.8 million doses of the Johnson & Johnson vaccine have been administered in the U.S., according to the FDA, the vast majority with no or mild side effects. In Wisconsin, 160,080 doses of the Johnson & Johnson vaccine have been administered as of Monday.

During a media briefing Tuesday, FDA director for the Center for Biologics, Evaluation and Research, Peter Marks, said the blood clots appear to be “extremely rare” but treatment is different from those used for other types of clots.

By not administering the vaccine, the CDC has time to determine if there are other cases of blood clots and has time to give health care providers information on how to treat it, according to DHS. A CDC committee will meet Wednesday to discuss the cases, and the FDA has also launched an investigation, according to the Associated Press.

“Health care providers who see people presenting to them with either a low blood platelet count or blood clots should establish whether or not the individual has recently been vaccinated in order to inform the appropriate diagnostic evaluation and management,” said Marks.

“I know that the information we’re providing today is going to be very concerning to Americans who have already received that Johnson & Johnson or Janssen vaccine,” said CDC deputy director Anne Schuchat. “And I want to let you know what we’re doing to learn more and to protect people in the meantime. And what you can do to be on the alert.”

Health officials, including DHS Secretary Karen Timberlake, are stressing the reaction to the vaccine is extremely rare. Health officials are also pointing out that the Pfizer and Moderna COVID-19 vaccines remain safe. The Pfizer and Moderna vaccines are both mRNA vaccines and are different than the Johnson & Johnson vaccine.

“We are pausing administration of the Johnson & Johnson vaccine out of an abundance of caution,” Timberlake said in a press release announcing the state’s decision. “At this time, these adverse events appear to be extremely rare. Vaccine providers should not administer the Johnson & Johnson vaccine at this time, and should hold on to the vaccine until federal review has been completed.”

During a Tuesday press conference in Milwaukee, Gov. Tony Evers credited the FDA and CDC for being transparent about the adverse reactions related to the Johnson & Johnson vaccine and the quick pivot to give health systems more time to adjust treatment options. He said despite only six reported cases of blood clots, the news is likely to make some uneasy about getting vaccinated against the coronavirus.

“This is going to make it more difficult because people that are hesitant can use this as another way to make an excuse for not getting … that vaccine,” said Evers. “But I believe we can overcome that. It’s just going to take time and a lot of effort. We don’t change our hesitancy overnight.”

Vaccine providers should continue to properly store the vaccine and continue reporting “adverse events” to the Vaccine Adverse Events Reporting System (VAERS).

Dr. Ryan Westergaard, chief medical officer for DHS, says residents vaccinated with the Johnson & Johnson vaccine should contact their health care provider if they have a severe headache or new vision problems in the two weeks after receiving the vaccine. He also says people should monitor for three weeks after being vaccinated for a severe headache, abdominal pain, leg pain or shortness of breath.

A total of 3,542,552 doses of the coronavirus vaccine have been administered in Wisconsin as of Monday, with 69.6 percent of Wisconsinites age 65 and up fully vaccinated. As of Monday, 1,423,723 people in Wisconsin, or 24.5 percent of the population, have been fully vaccinated. Anyone in Wisconsin age 16 and up is eligible for a coronavirus vaccine.

Editor’s note: This story will be updated.

DHS Tells Vaccinators To Stop Administering Johnson & Johnson COVID-19 Vaccine was originally published by Wisconsin Public Radio.