MDHHS gives FDA update for Janssen COVID-19 vaccine
Mich. (WNEM) - The Michigan Department of Health and Human Services is updating vaccine providers as the United States Food and Drug Administration limits the authorized use of giving the Janssen, also known as Johnson and Johnson, COVID-19 vaccine.
The FDA released a statement revising the emergency use and authorization of the Janssen vaccine.
The updated Emergency Use Authorization is as follows:
• Individuals 18 years of age and older for whom other authorized or approved COVID-19 vaccines are not accessible or clinically appropriate.
• 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.
The FDA discovered after an investigation the risk of thrombosis with thrombocytopenia syndrome is enough to limit the authorized risk of the vaccine.
TTS is a syndrome of rare and possible life-threatening blood clots mixed with low blood platelet levels. It is linked to the Janssen COVID-19 vaccine and has been presented within 10 to 14 days after receiving the vaccine.
The MDHHS said the FDA has found 60 confirmed TTS cases after residents receiving this vaccine, including nine deaths.
“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. “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.”
It is recommended by the MDHHS residents who received the Janssen vaccine get a mRNA booster dose.
Over 393,00 Michiganders have received the Janssen COVID-19 vaccine.
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