Aug 18, 2021 9:00:00 AM | 4 Min Read

FDA Authorized Booster for People With Weakened Immune Systems

FDA Authorized Booster for People With Weakened Immune Systems

Estimate impact of high-risk COVID population

As expected, on August 12, the U.S. Food and Drug Administration (FDA) authorized a booster dose of the COVID-19 mRNA vaccines for people with weakened immune systems. Multiple media reports gave no guidance at this time for people who had Johnson & Johnson's single-shot COVID-19 vaccination.

This news was followed on August 13 by the Centers for Disease Control and Prevention's (CDC) Advisory Committee on Immunization Practices (ACIP), voting unanimously that certain patients with weakened immune systems can get a booster shot of the Pfizer-BioNTech or Moderna mRNA vaccines.

The FDA, along with the Centers for Disease Control and Prevention (CDC) and the National Institutes of Health, is working through the details of how booster doses for this population will work for the third dose of both the Pfizer and Moderna mRNA vaccines.1

The CDC estimates that around 2.7% of adults in the United States are immunocompromised. People with weakened immune systems include those with cancer, those who have received an organ or stem cell transplant, have genetic conditions that weaken the immune function, have HIV, or other health conditions requiring treatment with medications. Certain medication treatments may decrease immune function, such as medication for rheumatoid arthritis.

New research shows that between one-third and one-half of immunocompromised patients who didn't develop detectable levels of virus-fighting antibodies after two doses of a COVID vaccine have responded well to a third dose.

Impact & Recommendations
Confidio has created an assessment tool to identify members that fit certain high-risk categories. Adults of any age within certain risk categories can be more likely to get severely ill from COVID-19. Severe illness means that a person with COVID-19 may need:

  • Hospitalization
  • Intensive care
  • A ventilator to help them breathe
  • Or they may even die

Your Confidio team can create an assessment of your current population to determine the estimated number of your members with conditions that could indicate weakened immune systems that might be eligible for a booster dose of the COVID-19 mRNA vaccines. While not expected to be a material impact, the data can be helpful to estimate added plan cost for the vaccine administration.

While not expected to be a material impact, the data can be helpful to estimate added plan cost for the vaccine administration. Further, you may choose to communicate to members regarding the FDA recommendation and encourage booster shots for members with weakened immune systems.

Also note, the FDA recommendation ensures that public and private insurers will cover a vaccine.

Future Considerations
The immune function also wanes with age, and with that, the FDA could consider boosters for the elderly. In addition, the U.S. plans to advise most Americans to receive a booster shot eight months following their initial mRNA vaccine regimen, with third shots planned for as early as mid-September, The New York Times reports. It’s thought that Johnson & Johnson recipients will also need an extra shot, but officials are awaiting the results of a trial testing two doses of the vaccine.


  1. Goodman B. FDA may OK covid booster for VULNERABLE adults Before Weekend: Media. Medscape. Published August 12, 2021. Accessed August 16, 2021.


Topics: FDA Approvals, Healthcare, COVID-19, Vaccine, Treatments

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