Florida Department of Health/Nassau
August 24, 2021
The following guidance are considerations for use of an additional mRNA COVID-19 vaccine dose after an initial two-dose primary mRNA COVID-19 vaccine series for immunocompromised people, as per the Centers for Disease Control and Prevention.
On August 12, 2021 the U.S. Food and Drug Administration (FDA) modified the Emergency Use Authorizations (EUA) for the Pfizer-BioNTech COVID-19 vaccine and Moderna COVID-19 vaccine to allow for administration of an additional dose (i.e., a third dose) of mRNA COVID-19 vaccine after an initial two-dose vaccine series for certain immunocompromised persons, such as persons who have undergone solid organ transplantation or have been diagnosed with conditions that are considered to have an equivalent level of immunocompromise.
The age groups authorized to receive the additional dose are unchanged from those authorized to receive the primary vaccination series, as stated below:
• Pfizer-BioNTech COVID-19 Vaccine: 12 years of age or older
• Moderna COVID-19 Vaccine: 18 years of age or older
On August 13, 2021, the Advisory Committee on Immunization Practices (ACIP) met and reviewed the data for use of an additional dose of mRNA COVID-19 vaccine for immunocompromised people within the Evidence to Recommendation Framework. The ACIP made an interim recommendation for use of an additional dose of Pfizer-BioNTech COVID-19 vaccine (for persons 12 years of age or older) or Moderna COVID-19 vaccine (for persons 18 years of age or older) after an initial two-dose primary mRNA COVID-19 vaccine series for moderately to severely immunocompromised people.
• Health care professionals and public health officials should consider the following for use of an additional mRNA COVID-19 vaccine dose after an initial two-dose primary mRNA COVID-19 vaccine series for moderately to severely immunocompromised people:
• The currently FDA-authorized COVID-19 vaccines are not live vaccines, and therefore can be safely administered to immunocompromised people.
• Studies indicate some immunocompromised people have a reduced immune response following a primary COVID-19 vaccine series compared to vaccine recipients who are not immunocompromised.
• Studies have further demonstrated that including an additional mRNA COVID-19 vaccine dose after an initial two-dose primary mRNA COVID-19 vaccine series in some immunocompromised populations may enhance immune response.
• The clinical benefit of an additional mRNA COVID-19 vaccine dose after an initial two- dose primary mRNA COVID-19 vaccine series for immunocompromised people is not precisely known. However, for people with moderate to severe immune compromise due to a medical condition or receipt of immunosuppressive medications or treatments, the potential to increase immune response coupled with an acceptable safety profile, support the recommendation for an additional mRNA COVID-19 vaccine dose after an initial two- dose primary mRNA COVID-19 vaccine series.
• The additional dose should be administered at least 28 days after the completion of the initial two-dose mRNA COVID-19 vaccine series.The clinical considerations for use of an additional dose of an mRNA COVID-19 vaccine apply only to people who are moderately or severely immunocompromised.
Interim Clinical Considerations for Use of COVID-19 Vaccines Currently Authorized in the United States: www.cdc.gov/vaccines/covid-19/clinical-considerations/covid-19-vaccines-us.html
Talking with Patients Who Are Immunocompromised: www.cdc.gov/vaccines/covid-19/clinical-considerations/immunocompromised-patients.html