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FDA Authorizes Second Booster Dose for Older Adults and Immunocompromised Individuals

Posted Mar 29, 20222 min Read

Regulatory & Clinical
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On March 29, 2022, the U.S. Food and Drug Administration has amended the emergency use authorizations and authorized a second booster dose of either Pfizer-BioNTech or Moderna COVID-19 vaccines for older individuals as well as certain immunocompromised individuals.  Ongoing review and emerging evidence suggest that a second booster dose of an mRNA COVID-19 vaccine will improve protections against severe COVID-19.  Importantly, the additional dose is not associated with new or additional safety concerns.

  • Individuals 50 years of age and older and at least 4 months after receipt of a first booster dose of any authorized or approved COVID-19 vaccine may now obtain a second booster dose of Pfizer-BioNTech COVID-19 Vaccine or Moderna COVID-19 Vaccine.
  • Individuals 12 years of age and older with certain kinds of immunocompromise at least 4 months after receipt of a first booster dose of any authorized or approved COVID-19 vaccine may now obtain a second booster dose of the Pfizer-BioNTech COVID-19 Vaccine. These are individuals who have undergone solid organ transplantation or are living with conditions that are considered to have an equivalent level of immunocompromise.
  • Individuals 18 years of age and older with the same certain kinds of immunocompromise list in the above paragraph may now obtain a second booster dose of Moderna COVID-19 Vaccine at least 4 months after the first booster does of any authorized or approved COVID-19 vaccine.
  • This amendment and action apply to the Pfizer-BioNTech and Moderna COVID-19 vaccines and specifically for the age groups outlined above only. All other age groups with these vaccines remains unchanged.

To read the FDA statement related to the new authorization, please click here.

Please forward questions to Lori Davenport at ldavenport@ihca.org

About the Author

Lori Davenport, Director of Clinical & Regulatory Affairs