NDDoH releases statement on FDA limiting use of Janssen COVID-19 vaccines

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Thursday the U.S. Food and Drug Administration (FDA) announced that they were further limiting the use of the Janssen (Johnson & Johnson) COVID-19 vaccine. Only individuals 18 years and older who are medically unable (i.e., severe allergy) to receive one of the mRNA (Moderna or Pfizer) vaccines or who would not otherwise receive COVID-19 vaccine are now eligible to receive a dose of Janssen COVID-19 vaccine. This change was made based on concerns of the risk of a rare and potentially deadly clotting condition called thrombosis with thrombocytopenia syndrome (TTS) after receiving the vaccine.

According to a statement by the FDA, the agency has been closely monitoring cases of TTS amongst Janssen vaccine recipients. In an updated analysis of vaccine safety data, a total of 60 cases of TTS post-Janssen vaccine have been found. This places the rate of TTS at 3.23 cases per million doses of vaccine administered and the rate of TTS deaths at 0.48 per million doses of vaccine administered. Because of the widespread availability of other effective COVID-19 vaccines the decision was made to limit the use of the Janssen vaccine. No cases of TTS have been reported in North Dakota.

In North Dakota the use of the Janssen vaccine has been minimal. Only 38,835 (3.6%) of the more than 1.07 million COVID-19 doses administered in the state have been Janssen COVID-19 vaccine. Many healthcare providers transitioned away from the use of the Janssen COVID-19 vaccine following an earlier decision from the CDC to express a preference for mRNA vaccines. Moving forward, North Dakota health care providers will be unable to routinely order Janssen COVID-19 vaccine. If a healthcare provider has a patient that requires Janssen COVID vaccine, doses will be made available.

COVID-19 disease continues to impact the citizens of North Dakota with 613 cases reported in the week of April 29 through May 5. To date, over 240,000 cases of COVID-19 have been reported in North Dakota. The rate of death amongst individuals with COVID-19 in North Dakota is 938 per 100,000 cases and the rate of hospitalization is 3,269 per 100,000 cases.

“The benefits of COVID-19 vaccines continue to outweigh the risks associated with COVID-19 illness.” said Molly Howell, NDDoH immunization director. “COVID-19 vaccines are an important tool for preventing serious outcomes, including hospitalization and death, due to COVID-19. North Dakotans who are not yet vaccinated or haven’t yet received a booster dose are encouraged to have a conversation with a trusted healthcare provider.”

Information about COVID-19 vaccine providers and clinics near you can be found on the NDDoH COVID Vaccine Locator page. Individuals can also contact the NDDoH public health hotline at 1-866-207-2880 for questions related to COVID-19 and for assistance in scheduling a vaccine appointment.

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