Ohio recommends temporary pause of Johnson & Johnson COVID vaccine

FDA, CDC advise providers to halt vaccine use due to rare blood clots

Ohio Department of Health officials and Gov. Mike DeWine are advising all coronavirus vaccine providers in the state halt the use of the Johnson & Johnson vaccine.

The recommendation came following a statement from the Food and Drug Administration and Centers for Disease Control advising a pause of the use of the vaccine due to rare blood clots reported in six people in the U.S. after they received the vaccine.

“Officials with the Ohio Department of Health are following this situation closely,” read a state from DeWine’s office.

Ohio House Minority Leader Emilie Sykes encouraged people to get the vaccinated and to talk to their health care provider.

“It is understandable that people are concerned by this news, and I agree that the right thing to do is to pause and take stock of what’s happening,” she said. “I encourage everyone with concerns to talk with their doctor or a trusted medical provider and to seek the most accurate and up-to-date information as you consider scheduling your vaccinations. If you are scheduled for a vaccine from the other FDA approved brands, please keep your appointment, but be sure to talk with a trusted medical provider if you have any questions.”

The CDC and FDA are schedule to hold a media briefing today. The CDC will also have a meeting with the Advisory Committee on Immunization Practices Wednesday.

According to the FDA, more than 6.8 million doses of the Johnson & Johnson vaccine have been administered in the U.S. as of Monday. Six of those who received the vaccine have reported a “rare and severe” blood clot afterward.

“Right now, these adverse events appear to be extremely rare,” the FDA said.

All six cases involved women between the ages of 18 to 48 and happened six to 13 days after receiving the vaccine, according to the joint statement from the CDC and FDA.

The joint statement said:

As of April 12, more than 6.8 million doses of the Johnson & Johnson (Janssen ) vaccine have been administered in the U.S. CDC and FDA are reviewing data involving six reported U.S. cases of a rare and severe type of blood clot in individuals after receiving the J&J vaccine. In these cases, a type of blood clot called cerebral venous sinus thrombosis (CVST) was seen in combination with low levels of blood platelets (thrombocytopenia). All six cases occurred among women between the ages of 18 and 48, and symptoms occurred 6 to 13 days after vaccination. Treatment of this specific type of blood clot is different from the treatment that might typically be administered. Usually, an anticoagulant drug called heparin is used to treat blood clots. In this setting, administration of heparin may be dangerous, and alternative treatments need to be given.

CDC will convene a meeting of the Advisory Committee on Immunization Practices (ACIP) on Wednesday to further review these cases and assess their potential significance. FDA will review that analysis as it also investigates these cases. Until that process is complete, we are recommending a pause in the use of this vaccine out of an abundance of caution. This is important, in part, to ensure that the health care provider community is aware of the potential for these adverse events and can plan for proper recognition and management due to the unique treatment required with this type of blood clot.

Right now, these adverse events appear to be extremely rare. COVID-19 vaccine safety is a top priority for the federal government, and we take all reports of health problems following COVID-19 vaccination very seriously. People who have received the J&J vaccine who develop severe headache, abdominal pain, leg pain, or shortness of breath within three weeks after vaccination should contact their health care provider. Health care providers are asked to report adverse events to the Vaccine Adverse Event Reporting System at https://vaers.hhs.gov/reportevent.htmlexternal icon.

- Joint CDC and FDA Statement on Johnson & Johnson COVID-19 Vaccine

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