INDIANAPOLIS — The Indiana State Department of Health has paused Johnson & Johnson COVID-19 vaccinations on the recommendation of federal health authorities, who are investigating reports of rare but potentially dangerous blood clots.
State health officials said Tuesday they decided to halt J&J vaccinations throughout the state “out of an abundance of caution” and pulled doses of the shots from its mass vaccination clinic at the Indianapolis Motor Speedway on Tuesday, sending doses of the Moderna vaccine instead.
The announcement from state health officials came after the Centers for Disease Control and Prevention and the Food and Drug Administration said they were investigating unusual blood clots in six women that occurred six to 13 days after vaccination, The Associated Press reported.
The clots occurred in veins that drain blood from the brain and occurred together with low platelets, according to wire reports. All six cases were in women between the ages of 18 and 48.
Nearly 7 million doses of the J&J vaccine have been administered in the U.S., including 932 given to Bartholomew County residents, according to the Indiana State Department of Health.
Locally, none of the COVID-19 vaccination sites in Bartholomew County were offering the J&J vaccine as of Tuesday morning, as most J&J shots in Indiana were set aside for mass vaccination clinics, where some Bartholomew County residents have been vaccinated, according to state records.
Columbus Regional Health, which operates a vaccination clinic near its hospital campus in Columbus, is only administering the Pfizer-BioNTech vaccine. Cummins Inc. also has made the Pfizer vaccine available to employees and eligible dependents.
The Bartholomew County Health Department has mostly given the Moderna vaccine, though county health officials received 100 doses of the J&J vaccine last month and administered all of them to people living in congregate settings, such as homeless shelters, said Amanda Organist, the department’s director of nursing.
Organist said state health officials notified her office Tuesday morning that all J&J vaccinations were to be placed on hold until further notice.
Sam’s Club, Walmart and Kroger are only offering the Moderna vaccine.
Local health officials said they understand that the decision to pause J&J vaccinations may raise concerns among the public about the other two authorized COVID-19 vaccines.
However, officials reiterated that severe side effects from any of the vaccines are rare and that the same system for monitoring side effects that raised a “caution flag” about the J&J vaccine has not found any risks with the Moderna or Pfizer vaccines.
“The first thing is this is less than one in a million,” said Dr. Slade Crowder, Columbus Regional Health vice president of physician enterprise operations and associate chief medical officer. “People who have gotten the J&J vaccine already should not be afraid. We know it’s still effective. And it still hasn’t been proven to be a causal relationship. The next step is to analyze the data and see if these six out of (nearly) 7 million people is more than what would be expected in the general population.”
“There are mechanisms in place to ensure safety,” he said. “…That same sort of surveillance is ongoing with the other vaccines, and we haven’t seen any risks.”
Dr. Brian Niedbalski, Bartholomew County health officer, emphasized that the J&J vaccine uses different technology than the Pfizer and Moderna vaccines, which he said “are still proven safe.”
The Pfizer-BioNTech and Moderna vaccines work by introducing into the body non-infectious snippet of genetic material called messenger RNA, or mRNA, wrapped in a protective coating.
The mRNA contains instructions to cells to build a piece of the so-called “spike protein” that is unique to SARS-CoV-2, the virus that causes COVID-19, according to the Centers for Disease Control and Prevention.
The J&J vaccine uses a genetically modified version of a harmless adenovirus — called a viral vector — that contains a small piece of genetic instructions for the coronavirus’ spike protein, according to wire reports.
“I’d like to point out to people that the J&J vaccine works via a viral vector process that is different than the Moderna and Pfizer mRNA vaccines,” Niedbalski said. “I understand this will raise concerns with the public, but these other two vaccines are still proven safe and effective. It is unfortunate that several women have suffered cerebral venous thrombosis shortly after receiving the J&J vaccine. Pausing the use of that vaccine is the right decision until more data is available.”
People who have already received the J&J vaccine should notify their doctor if they develop severe headache, severe abdominal pain, shortness of breath, blurred vision, loss of consciousness, or seizures, health officials said.
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, according to wire reports.
Authorities have not seen similar clots after use of the Pfizer or Moderna vaccines, the CDC’s Dr. Anne Schuchat told the The Associated Press.
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Visit ourshot.in.gov or call 211 to schedule an appointment to get the Pfizer or Moderna COVID-19 vaccine.
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