Last week, the U.S. Department of Health and Human Services (HHS) announced a plan to deliver booster shots for individuals who have been vaccinated with the Pfizer-BioNTech COVID-19 Vaccine or the Moderna COVID-19 Vaccine. This comes on the heels of an announcement by the U.S. Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices (ACIP) to allow for the use of an additional dose of the Pfizer or Moderna vaccine in certain immunocompromised individuals.
What is the difference between a booster and an additional dose for the immunocompromised?
A “booster” is given to someone who created a normal immune response from the initial series, but that immune response waned over time. So, a booster is given at a specific time frame based on evidence that shows immunity is waning. HHS announced that it is preparing to deliver boosters after eight months of the final dose. This dose is not considered a part of the primary series.
It is important to note that the FDA and the CDC’s ACIP must first meet to approve the vaccine booster before it can be recommended for use.
The additional dose for the immunocompromised is being recommended due to evidence that the initial immune response in these individuals was not adequate. The ACIP reviewed data that indicated that individuals with moderate to severe immunosuppression do not create an adequate immune response after the initial two dose series of the Pfizer and Moderna, and as a result, it is recommending a third dose as part of the primary series at least 28 days after completion of the first two doses.
Who is considered immunocompromised?
People with moderate to severe immune compromise due to a medical condition or receipt of immunosuppressive medications or treatments are eligible to receive an additional dose. These conditions and treatments include but are not limited to:
- Active treatment for solid tumor and hematologic malignancies
- Receipt of solid-organ transplant and taking immunosuppressive therapy
- Receipt of CAR-T-cell or hematopoietic stem cell transplant (within two years of transplantation or taking immunosuppression therapy)
- Moderate or severe primary immunodeficiency (e.g., DiGeorge syndrome, Wiskott-Aldrich syndrome)
- Advanced or untreated HIV infection
- Active treatment with high-dose corticosteroids (i.e., ≥20mg prednisone or equivalent per day), alkylating agents, antimetabolites, transplant-related immunosuppressive drugs, cancer chemotherapeutic agents classified as severely immunosuppressive, tumor-necrosis (TNF) blockers, and other biologic agents that are immunosuppressive or immunomodulatory.
More information is available
here.
Who should receive a booster and when?
Pending approval by the FDA and the CDC’s
ACIP, all individuals who have been vaccinated with the Pfizer or Moderna should receive a booster shot eight months after the second dose. The recommended time frame will be confirmed by the FDA and ACIP, but HHS is preparing for a time frame of eight months after receipt of the final dose.
Does this change the definition of “fully vaccinated”?
No, the definition of fully vaccinated has not changed. As of now, the definition of fully vaccinated remains as two weeks after completion of the series (one or two doses).
What about people who received the Johnson and Johnson/Janssen vaccine?
Right now, individuals who have received the J&J/Janssen vaccine are not recommended to get a third shot or an additional shot for the immunocompromised. The CDC and FDA are actively reviewing data from the J&J vaccine to see if there is any waning immunity and will be making recommendations once enough data is available.
What should I do next?
Providers can take a few key steps to start preparing.
- Identify residents (and/or their representatives) who meet the eligibility criteria for being immunocompromised and offer them the third dose or to talk to their physician about receiving a third dose of an mRNA vaccine. Individuals can self-attest and receive the additional dose wherever vaccines are offered.
- Talk to your LTC pharmacy about preparing to deliver the booster shot, once available. If you do not have a contractual arrangement with an LTC pharmacy, we recommend you talk to your state health department or seek a partner through the Federal Pharmacy Partnership Program.
- Continue to encourage uptake among residents and staff. Check out the #GetVaccinated campaign website for resources.