FDA and ACIP recommend an additional mRNA COVID-19 vaccine dose for immunocompromised people
Summary and Action Items
- On August 12, 2021, FDA modified the Emergency Use Authorizations for Pfizer-BioNTech and Moderna COVID-19 vaccines to allow for administration of an additional (i.e. 3rd) dose of an mRNA vaccine after an initial 2-dose primary mRNA COVID-19 vaccine series for certain immunocompromised people (i.e. solid organ transplantation or equivalent immunocompromise).
- The age groups authorized to receive the additional dose are unchanged: Pfizer-BioNTech – age 12 and older, Moderna – age 18 and older.
- On August 13, 2021, ACIP made an interim recommendation for use of an additional dose of Pfizer BioNTech or Moderna COVID-19 vaccine after an initial 2-dose primary mRNA COVID-19 vaccine series for people who are moderately to severely immunocompromised.
Background: Immunocompromised people comprise about 2.7% (7 million) of U.S. adults. They are more likely to get severely ill from COVID-19 and are more likely to have a breakthrough infection (40-44% of hospitalized breakthrough cases were immunocompromised people in one study). 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 2-dose primary mRNA COVID-19 vaccine series in some immunocompromised populations may enhance immune response.
Interim Clinical Considerations: Healthcare professionals and public health officials should consider the following for use of an additional mRNA COVID-19 vaccine dose after an initial 2-dose primary mRNA COVID19 vaccine series for moderately to severely immunocompromised people only:
- The currently FDA-authorized COVID-19 vaccines are not live vaccines and therefore can be safely administered to immunocompromised people.
- The clinical benefit of an additional mRNA vaccine dose after an initial 2-dose primary mRNA COVID19 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 vaccine dose after an initial 2-dose primary mRNA COVID-19 vaccine series.
- The additional dose should be administered at least 28 days after the completion of the initial mRNA COVID-19 vaccine series.
- For public health purposes, immunocompromised people who have completed a primary vaccine series (i.e., 2-dose mRNA vaccine series [Pfizer-BioNTech and Moderna] or single dose of the Janssen vaccine) are considered fully vaccinated ≥2 weeks after completion of the series.
- A patient’s clinical team is best positioned to determine the degree of immune compromise and appropriate timing of vaccination.
- Moderate to severe immune compromise due to a medical condition or receipt of immunosuppressive medications or treatments include but are not limited to:
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- 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 2 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.
- Currently there are insufficient data to support the use of an additional mRNA COVID-19 vaccine dose after a single-dose Janssen COVID-19 vaccination series in immunocompromised people. FDA and CDC are actively working to provide guidance on this issue.
Immunocompromised people (including those who receive an additional mRNA dose) should be counseled about the potential for reduced immune response to COVID-19 vaccination and need to follow prevention measures:
- Wear a mask
- Stay 6 feet apart from others they don’t live with
- Avoid crowds and poorly ventilated indoor spaces until advised otherwise by their healthcare provider
Close contacts of immunocompromised people should be strongly encouraged to be vaccinated against COVID-19
Additional Information for Providers:
- Interim Clinical Considerations for Use of COVID-19 Vaccines | CDC
- Additional Dose of mRNA COVID-19 Vaccine for Patients Who Are Immunocompromised | CDC
- COVID-19 Vaccines for Moderately to Severely Immunocompromised People | CDC
Strengthened COVID-19 Vaccine Recommendation in Pregnancy:
On August 11, 2021, CDC strengthened its recommendation for COVID-19 vaccination in pregnant people stating COVID-19 vaccination is recommended for all people aged 12 years and older, including people who are pregnant, lactating, trying to get pregnant now, or might become pregnant in the future. CDC recommendations now align with those from professional medical organizations serving people who are pregnant, including the American College of Obstetricians and Gynecologists and the Society for Maternal Fetal Medicine. Pregnancy is not considered moderate or severe immunocompromise.
Data shows that there is no evidence that any of the COVID-19 vaccines affect current or future fertility.
- COVID-19 vaccines do not cause infection in the pregnant person or the fetus
- No safety signals in animal studies
- Reassuring early safety data on mRNA COVID-19 vaccines during pregnancy
- Early data suggest mRNA COVID-19 vaccines during pregnancy are effective
Only 23 percent of pregnant people have received even one dose of COVID-19 vaccine in the United States. OB/GYN providers should consider stocking COVID-19 vaccine along with influenza and Tdap vaccine in their offices or help facilitate vaccination appointments and opportunities.