Dr. Natasha Bagdasarian, MDHHS chief medical executive

LANSING — The Michigan Department of Health and Human Services is updating vaccine providers across the state about the U.S. Food and Drug Administration limiting the authorized use on the administration of the Janssen COVID-19 vaccine.

The FDA on May 5 released a statement that it has revised its emergency use authorization and limited the authorized use of the Janssen COVID-19 vaccine. Janssen Biotech Inc. is a Janssen Pharmaceutical Company of Johnson & Johnson.

The updated emergency use authorization limits use to:

– Individuals 18 years of age and older for whom other authorized or approved COVID-19 vaccines are not accessible or clinically appropriate; or

– Individuals 18 years of age and older who elect to receive the Janssen COVID-19 vaccine because they would otherwise not receive a COVID-19 vaccine.

Based on its investigation, the FDA has determined that the risk of thrombosis with thrombocytopenia syndrome, or TTS, warrants limiting the authorized use of the vaccine, according to MDHHS. TTS is a syndrome of rare and potentially life-threatening blood clots in combination with low levels of blood platelets. TTS linked with the Janssen COVID-19 vaccine has most frequently presented within 10 days to two weeks following vaccine administration, officials said.

The FDA and Centers for Disease Control and Prevention have identified 60 confirmed TTS cases following the administration of Janssen COVID-19 vaccine, including nine fatal cases, according to officials. The FDA has determined that the reporting rate of TTS is 3.23 per million doses of vaccine administered and the reporting rate of TTS deaths is 0.48 per million doses of vaccine administered.

“Throughout the pandemic, our federal partners have been committed to ensuring that science and data guided their decisions,” said Dr. Natasha Bagdasarian, MDHHS chief medical executive, in a statement. “These new guidelines further underscore the robust safety review process in place for these vaccines. We continue to urge all Michiganders ages 5 and older to get their safe and effective COVID-19 vaccine as soon as possible and to get boosted if eligible.”

For individuals who have received the Janssen COVID-19 vaccine as their primary dose, it is recommended they receive a COVID-19 vaccine booster dose and mRNA vaccines are preferred for the first booster dose, according to MDHHS.

Additionally, if Janssen COVID-19 vaccine was used for both the primary and booster doses, individuals are eligible for an additional dose of an mRNA vaccine.

In both instances, vaccine protection has been shown to increase following administration of an mRNA vaccine, according to MDHHS.

To date, nearly 6.7 million state residents, 67% of the population, have received their first does of COVID-19 vaccine.

More than 393,000 residents have received the Janssen COVID-19 vaccine, according to MDHHS.

Michigan residents seeking more information about the COVID-19 vaccine can visit Michigan.gov/COVIDvaccine.