Local Mass Vaccine Clinics Canceled over Concerns about J&J Shot

Updated 10:40 a.m. with information from FDA/CDC press conference and Associated Press
YOUNGSTOWN, Ohio – The Youngstown City Health District and Mahoning County Public Health have canceled their mass vaccination clinics that use the Johnson & Johnson vaccine.

The city health district was hosting clinics at Youngstown State University today, along with at the Covelli Centre April 14 and 22. The county department has canceled its April 16 and 17 dates at its clinic at the Southern Park Mall.

Mahoning County Public Health said in a statement that it was working with the Ohio Department of Health to obtain either Pfizer or Moderna shots for its clinics April 23 and 24.

In a statement, city health commissioner Erin Bishop said the agency had “plenty of open appointments” for its vaccination clinics April 20 and 21 at Congregation Rodef Sholom offering the Moderna vaccine. Registration for the clinics is available at COVID19.YoungstownOhio.gov.

The announcement came after the Food & Drug Administration and the Centers for Disease Control urged health departments to suspend the use of Johnson & Johnson vaccines. 

Six recipients of the vaccine – out of some 7 million nationwide – developed a rare blood clot disorder within two weeks of getting their shot. All six are women between 18 and 48; one patient died and a second is reported to be in critical condition. 

In the announcement, Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, and Dr. Anne Schuchat, principal deputy director of the CDC, said in a joint statement said the recommendation is made “out of an abundance of caution. … Right now, these adverse events appear to be extremely rare.”

At a Tuesday morning press conference, FDA acting commissioner Janet Woodcock said the agency expects the pause to last “a matter of days.”

Following the federal agencies’ statement, Gov. Mike DeWine and two Ohio Department of Health officials advised all vaccine providers in the state to pause using the Johnson & Johnson vaccine.

The federal agencies are recommending that people who were given the J&J vaccine who are experiencing severe headache, abdominal pain, leg pain, or shortness of breath within three weeks after receiving the shot contact their health care provider.

J&J said in a statement it was aware of the reports of blood clots, but that no link to its vaccine had been established. The company also said it is delaying 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. “In this setting, administration of heparin may be dangerous and alternative treatments need to be given,” the FDA and CDC said.

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.

As authorities investigate whether the clots really are related to the J&J vaccine, Barnes stressed that it’s important Americans get vaccinated as soon as possible using the other two available vaccines, from Pfizer and Moderna.

“If you have a chance to get vaccinated with those, we strongly encourage it. The risks of COVID are real and they’re high,” Barnes said.

Jeff Zients, the White House COVID-19 response coordinator, said 28 million doses of the Pfizer and Moderna vaccines will be available for states this week, more than enough to keep up the nation’s pace of 3 million shots a day despite the J&J pause.

Asked if the government was overreacting to six cases out of more than 6 million vaccinations, 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.”

States and cities swiftly moved to implement the pause. New York state health commissioner Dr. Howard Zucker said people with Tuesday appointments for J&J vaccines at state-run mass vaccination clinics will instead get the Pfizer vaccine.

The city of Dallas had planned to begin an in-home vaccination program using the J&J vaccine for homebound or elderly people. The city said it will pause the program until more guidance is released.

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 U.S. 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 U.S. 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 COVID-19 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 Associated Press contributed to this story.

Copyright 2021 The Business Journal, Youngstown, Ohio.