Ohio, Michigan temporarily suspend J&J vaccine as U.S. investigates clots

Apr. 14—Ohio and Michigan joined states across the country in temporarily suspending the use of the single-dose Johnson & Johnson coronavirus vaccine in accordance with the federal recommendation while authorities investigate reports of potentially dangerous blood clots.

Gov. Mike DeWine stressed in a news conference Tuesday that the pause is expected to be brief — days to maybe a couple weeks — while the Centers for Disease Control and Prevention and the Food and Drug Administration investigate unusual clots that formed in six out of 6.8 million recipients of the J&J vaccine.

All six cases were in women between the ages of 18 and 48 who had received their shot 6 to 13 days prior to finding the clots. The clots occurred in veins that drain blood from the brain and occurred together with low platelets.

The temporary pause, said to be out of an abundance of caution to allow health providers and recipients to recognize the signs and symptoms of the rare reaction and learn to treat it, should actually bring Ohioans comfort, the state's Chief Medical Officer Dr. Bruce Vanderhoff said.

"The bottom line is that these cases appear to be extremely rare, and the fact that the CDC and FDA have raised concerns and pushed the pause button on the basis of these six cases should give Ohioans great confidence in not only the priority that is being placed on vaccine safety, but also the reliability and transparency of the CDC's and FDA's safety monitoring system," he said.

Anyone who received the J&J vaccine is advised to seek medical care if they experience a severe headache, abdominal pain, leg pain, or shortness of breath within three weeks after receiving their shot.

Anyone who received the J&J shot before March 22 is at low risk of complications, the Toledo-Lucas County Health Department said. Anyone who received the shot after that date should monitor for symptoms outside of the mild flulike symptoms that are common after any vaccination.

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During the pause Mr. DeWine encouraged residents to continue to seek vaccination via Moderna or Pfizer, which use a different technology than the Johnson & Johnson vaccine and have not raised similar health concerns.

"We know that those are in fact safe," Mr. DeWine said.

Most of the providers who had already scheduled appointments for the J&J vaccine are substituting one of the other shots for now and storing their shipments of J&J to be used at a later date, if the pause is lifted.

The mass vaccination site at the Lucas County Rec Center in Maumee, for example, is among half a dozen sites in the state currently switching to Moderna. Lucas County Health Commissioner Eric Zgodzinski announced Tuesday that anyone currently signed up to be vaccinated will have a dose available, though they must be able to return May 11 for their second.

"If you still want to be vaccinated, which I encourage everybody to do, it will not be the Johnson & Johnson product, it will be the Moderna product," Mr. Zgodzinski said.

Vaccination clinics at the University of Toledo have now been canceled or updated to offer only Pfizer vaccines, and clinics scheduled at Bowling Green State University this week have been canceled in lieu of other community options.

"The University has an adequate supply of Pfizer vaccines and appointment times to meet the needs of our campus community," a UT spokesman said in an emailed statement. "Prior on-campus vaccine clinics for our students and employees have distributed the Pfizer or Moderna vaccine only."

A "pause" for even a short time interrupts Mr. DeWine's goal of vaccinating as many students on the college and university campuses before they graduate or head home for summer.

Last week 63 public and private 4-year institutions across the state had received J&J doses to administer to students. "The good news is many of them finished the vaccinations last week," Mr. DeWine said, but some of the larger schools that weren't able to get to every student are now waiting.

Bruce Johnson, president of the Inter-University Council of Ohio, said he was already trying to gauge the remaining demand for vaccines on campuses even before the Johnson & Johnson interruption. This was the second week of the governor's plan.

"Many students...had already received the Johnson & Johnson, and the demand was waning, but that's not true on every campus," he said. "It depends on the delivery and logistical issues. We'll figure out whether there is demand for another vaccine or not. It's too early to tell."

He said many students had already pursued two-dose Pfizer or Moderna vaccinations on their own, and some Pfizer doses had also been made available on campuses.

The Ohio Department of Health said it is working on alternative plans for those with Johnson & Johnson clinics scheduled this week. It has advised providers to keep its Johnson & Johnson supplies in proper storage.

"If providers do not have vaccines available from another manufacturer, we are recommending that they work with the patients to cancel or reschedule those appointments for a future date," said spokesman Alicia Shoults.

Ohio Northern University announced Tuesday that its state-sponsored, mobile, mass-vaccination clinics scheduled in Hardin, Logan, Union, Marion, Crawford, and Wyandot counties have been paused, but College of Pharmacy Dean Steven Martin said they'd made an appeal to the state for doses of one of the other two vaccines "so we can keep going."

Mr. DeWine indicated Tuesday that the college will be among those now offering the Moderna vaccine in J&J's stead.

Despite BGSU's on-campus clinics being canceled, Wood County Health Commissioner Ben Robison said students who had signed up for one of the 4,000 Johnson & Johnson doses are now encouraged to sign up to receive the Pfizer vaccine at any of the health department's other planned clinics this week. Those locations can be found on the health department's website, and all of them now offer walk-in options.

"For now we're focusing on moving the doses we already have, and the best vaccine remains the one available to you," Mr. Robison said. "Everything else that we have on the calendar is all Pfizer based clinics."

The interruption comes soon after Ohio expanded eligibility for vaccines to anyone over the age of 16 as the state seeks to head off another major surge in new infections, like the one Michigan is currently experiencing.

Ohio reported 2,340 new coronavirus cases Tuesday, just above the 21-day average of 1,948.

Meanwhile the statewide vaccination total climbed to 4.1 million people who have started on the two-shot vaccine, or 35.59 percent of Ohioans. The percent vaccinated locally reached 35.15 percent in Lucas County and 40.80 percent in Wood County, well below the 70-percent compliance officials say is needed to reach herd immunity.

Mr. DeWine said there has been a "slackening" in demand for vaccines across the state.

Despite more than 6.8 million doses of the J&J vaccine being administered in the United States, only about 264,311 have gone to Ohioans, Mr. DeWine said. And the vast majority of them have been received with no or mild side effects.

Lt. Gov. Jon Husted, who received the J&J vaccine about 5 weeks ago, said he had no complications or side effects, and neither has any of his staff who also received it.

"Based on my experience, I would recommend it to family and friends," Mr. Husted said.

None of the 700 J&J doses delivered in Wood County have resulted in adverse side effects, either, Mr. Robison said.

Of the 10,500 doses administered in Lucas County, Mr. Zgodzinski said he's aware of one case that did result in a person going to the emergency room following a reaction, but he didn't say whether it was related to a blood clot issue. None of the reactions for any of the vaccines have been life-threatening.

While Mr. Zgodzinski applauded the decision to pause the Johnson & Johnson vaccine while its safety is further evaluated, he recognized that the loss of about 5,000 doses that were ready to be administered this week does "significantly reduce our ability to get the vaccine out faster because it's a single dose."

A program that started last week to vaccinate homebound residents is now expected to transition to one of the two-dose vaccines, he said, but official plans have not been announced.

CDC's Advisory Committee on Immunization Practices 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.

"Until that process is complete, we are recommending a pause in the use of this vaccine out of an abundance of caution," Dr. Anne Schuchat, principal deputy director of the CDC, and Dr. Peter Marks, director of the FDA's Center for Biologics Evaluation and Research, said in a joint statement.

U.S. health authorities cautioned doctors against using a typical clot treatment, the blood-thinner heparin. "In this setting, administration of heparin may be dangerous and alternative treatments need to be given," the FDA and CDC said.

The reports appear similar to a rare, unusual type of clotting disorder that European authorities say is possibly linked to the AstraZeneca coronavirus vaccine not yet cleared in the United States.

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.

Johnson & Johnson said it was aware of the reports of "thromboembolic events," or blood clots, but that no link to its vaccine had been established.

The J&J vaccine received emergency use authorization from the FDA in late February with great fanfare, with hopes that its single-dose and relatively simple storage requirements would speed vaccinations across the country. Yet the shot only makes up a small fraction of the doses administered in the United States as 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.

Only about 9 million of the company's doses have been delivered to states and are awaiting administration, according to CDC data.

Until now concern about the unusual blood clots has centered on the vaccine from AstraZeneca, which has not yet received authorization in the United States. Last week European regulators said they found a possible link between the shots and a very rare type of blood clot that occurs together with low blood platelets, one that seems to occur more in younger people.

The European Medicines Agency stressed that the benefits of receiving the vaccine outweigh the risks for most people. But several countries have imposed limits on who can receive the vaccine; Britain recommended that people under 30 be offered alternatives.

But the J&J and AstraZeneca vaccines are made with the same technology. Leading coronavirus vaccines train the body to recognize the spike protein that coats the outer surface of the coronavirus. But the J&J and AstraZeneca vaccines use a cold virus, called an adenovirus, to carry the spike gene into the body. J&J uses a human adenovirus to create its vaccine while AstraZeneca uses a chimpanzee version.

The announcement hit U.S. stock markets immediately, with Dow futures falling almost 200 points just over two hours before the opening bell. Shares of Johnson & Johnson dropped almost 3 percent.

Health officials continue to stress that the investigation into the J&J vaccine is not a reflection of the safety of the Pfizer or Moderna vaccines. As coronavirus cases continue to climb across Ohio, and with some areas reporting vaccine uptake slowing, officials continue to urge residents to consider getting their shot.

All three vaccines have proven effective against reducing hospitalizations and preventing deaths, and Moderna and Pfizer are not affected by the pause.

"There's a lot of benefit there, and the more we can vaccinate in our community, the more the benefit will be felt across the community," Mr. Robison said.

Information from The Blade's news services was used in this report.

First Published April 13, 2021, 7:21am