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FDA limits authorization for J&J COVID-19 vaccine

In a new message to providers May 5, 2022, CMS is noting that the FDA has limited the authorized use of the Janssen (Johnson & Johnson) COVID-19 vaccine.

The vaccine is now only authorized for patients 18 years or older:

  • For whom other authorized or approved COVID-19 vaccines are not accessible or clinically appropriate
  • Who elect to receive the Janssen COVID-19 vaccine because they would otherwise not receive a COVID-19 vaccine

Providers billing Medicare for patient vaccinations should monitor CMS messages at https://www.cms.gov/covidvax-provider.