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Wisconsin pauses J&J COVID-19 vaccine as recommended by federal officials
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COVID-19 | VACCINES

Wisconsin pauses J&J COVID-19 vaccine as recommended by federal officials

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Pop-up vaccination clinic (copy)

Areli Martinez, left, a certified pharmacy technician, vaccinates Madison resident Allison Leasure, 35, against COVID-19 during a pop-up clinic Sunday at Trinity United Methodist Church. Leasure was one of more than 500 people who lined up around the block to get vaccinated in the small church basement.

Health officials in Wisconsin said Tuesday they would press on with COVID-19 vaccination using the Moderna and Pfizer vaccines after pausing use of the single-dose Johnson & Johnson injection as recommended by federal authorities.

The Centers for Disease Control and Prevention and the Food and Drug Administration said they were investigating unusual blood clots in six women between the ages of 18 and 48, with one death, out of more than 6.8 million recipients of the J&J vaccine nationally. The move set off a chain reaction worldwide and dealt a setback to the global vaccination campaign.

“We’re very hopeful that this will be a fairly short pause and we’ll be back administering J&J very shortly,” said Julie Willems Van Dijk, deputy director of the Wisconsin Department of Health Services. For now, “we will continue our path forward with a really stable supply of Moderna and Pfizer,” she said.

About 96% of COVID-19 vaccinations given so far in Wisconsin have been Moderna or Pfizer vaccines, with J&J accounting for just 4%. The state this week is receiving about 10,000 doses of the J&J vaccine, which state health officials told vaccinators to keep in storage, and was planning on only 3,000 doses next week before a greater supply was expected in May.

None of the six cases of blood clots was known to have occurred in Wisconsin, Willems Van Dijk said. The J&J vaccine has been used throughout the state, especially by local health departments, she said. Public Health Madison and Dane County said people with appointments to get the J&J vaccine this week at the Alliant Energy Center will be contacted to reschedule their vaccine appointments.

About 1 in 1 million people who got the J&J vaccine are known to have developed the blood clots, while the risk of getting COVID-19 in the U.S. is about 1 in 10 and the risk of dying from it is about 1 in 600, Willems Van Dijk said. “It’s really important to look at that whole picture,” she said.

The acting FDA commissioner expected the pause to last only a matter of days. But the decision triggered swift action in Europe and elsewhere as the drugmaker and regulators moved to halt the use of the J&J vaccine, at least for now. Hundreds of thousands of doses were due to arrive in European countries this week. The European Union has been plagued by supply shortages, logistical problems and concerns over blood clots in a small number of people who received the AstraZeneca vaccine.

Any slowdown in the dissemination of the shots could have broad implications for the global vaccination effort. The J&J vaccine held immense promise because its single-dose regimen and relatively simple storage requirements would make it easier to use, especially in less affluent countries.

The clots, which happened six to 13 days after vaccination in veins that drain blood from the brain, occurred together with low platelets, the fragments in blood that normally form clots.

The FDA said the cases under investigation appear similar to the clots that European authorities say are possibly linked to the AstraZeneca vaccine, which is not yet cleared in the U.S. European regulators have stressed that the AstraZeneca risk appears to be lower than the possibility of developing clots from birth control pills.

Federally run mass vaccination sites plan to pause the use of the J&J shot, and several states and other providers announced plans to the do the same. But authorities stressed they have found no signs of clot problems with the most widely used COVID-19 vaccines in the U.S. — from Moderna and Pfizer.

“I’d like to stress these events appear to be extremely rare. However, COVID-19 vaccine safety is a top priority,” acting FDA Commissioner Janet Woodcock said at a news conference.

Speaking at the White House, Dr. Anthony Fauci, the nation’s top expert on infectious disease, said the pause would allow the FDA and the CDC to investigate the clotting cases “to try and understand some of the mechanisms” and “to make physicians more aware of this.”

A CDC committee will meet Wednesday to discuss the cases, and the FDA has also launched an investigation into the cause of the clots and low platelet counts.

Not a mandate

FDA officials emphasized that Tuesday’s action was not a mandate. Doctors and patients could still use J&J’s vaccine if they decide its benefits outweigh its risks for individual cases, said Dr. Peter Marks.

The agencies recommend that people who were given the J&J vaccine should contact their doctor if they experience severe headache, abdominal pain, leg pain or shortness of breath within three weeks.

J&J said in a statement that it was aware of the reports of blood clots, but that no link to its vaccine had been established. The company also said it would delay the rollout of its vaccine in Europe as a precaution.

U.S. health authorities cautioned doctors against using a typical clot treatment, the blood-thinner heparin.

European authorities investigating the AstraZeneca cases have concluded clots appear to be similar to a very rare abnormal immune response that sometimes strikes people treated with heparin, leading to a temporary clotting disorder.

While it’s not clear yet if the reports among J&J recipients are related, doctors would treat these kinds of unusual clots like they treat people who have the heparin reaction — with different kinds of blood thinners and sometimes an antibody infusion, said Dr. Geoffrey Barnes, a clot expert at the University of Michigan.

Summer target

Even without J&J’s vaccine, White House officials said they remain on track to have enough supplies to vaccinate most American adults by the summer.

“We believe there’s enough vaccine in the system — Moderna and Pfizer — for all Americans who want to get vaccinated by May 31 to do so,” said Jeff Zients, the White House’s COVID-19 response coordinator.

Asked if the government was overreacting to six cases out of more than 6 million vaccinations, the CDC’s Dr. Anne Schuchat said recommendations will come quickly.

Because these unusual clots require special treatment, “it was of the utmost importance to us to get the word out,” she said. “That said, the pandemic is quite severe and cases are increasing in lots of places and vaccination’s critical.”

The J&J vaccine received emergency use authorization from the FDA in late February with great fanfare. Yet the shot only makes up a small fraction of the doses administered in the U.S. J&J has been plagued by production delays and manufacturing errors at the Baltimore plant of a contractor.

Last week, the drugmaker took over the facility to scale up production in hopes of meeting its commitment to the U.S. government of providing about 100 million doses by the end of May.

State Journal reporter David Wahlberg contributed to this report.

About 1 in 1 million people who got the J&J vaccine are known to have developed the blood clots. The risk of getting COVID-19 in the U.S. is about 1 in 10, and the risk of dying from it is about 1 in 600.

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