Yes. Evidence continues to demonstrate that COVID-19 vaccination is safe and effective during any stage of pregnancy; the benefits of vaccination clearly outweigh any known or potential risks of COVID-19 vaccination during pregnancy. The currently licensed or authorized COVID-19 vaccines are non-replicating vaccines and cannot cause infection in either the pregnant person or the fetus. No evidence exists of risk to the fetus from vaccinating pregnant people with non-replicating vaccines in general.
Data from the Vaccine Adverse Events Reporting System (VAERS), the V-safe surveillance system, and the V-safe pregnancy registry have not signaled any safety concerns for pregnant people who were vaccinated or their infants. The vaccine manufacturers are following the pregnancy outcomes of people in the clinical trials who became pregnant. Additional studies in pregnant people are ongoing in order to fully evaluate pregnancy and birth outcomes.
All people who are pregnant are recommended to receive an updated (2023–2024 Formula) COVID-19 vaccine, as licensed or authorized by FDA, if they have not already received one.
Last reviewed:
March 19, 2024
Yes. COVID-19 vaccination is recommended for all people who are not up to date, including those who are pregnant or lactating. Pregnant people are at increased risk of severe complications and death from COVID-19 compared to non-pregnant people of the same age. Those who contract COVID-19 during pregnancy also have almost twice the risk of stillbirth compared to those who do not contract COVID-19 during pregnancy. Studies have shown that antibodies produced after COVID-19 vaccination during pregnancy are transferred to the newborn, and COVID-19 vaccination of people who are pregnant reduces the risk of COVID-19 hospitalization in infants younger than 6 months. Pregnant people should receive any licensed or authorized updated 2023–2024 Formula COVID-19 vaccine during pregnancy, as licensed or authorized by FDA.
There is no recommendation from CDC for COVID-19 vaccination during every pregnancy; therefore, at this time, a person who is up to date on COVID-19 vaccination and becomes pregnant is not recommended to get an additional dose.
CDC, the American College of Obstetricians and Gynecologists (ACOG), and the Society for Maternal-Fetal Medicine (SMFM) all recommend vaccination, when indicated, of pregnant people at any stage of pregnancy.
For more details about COVID-19 vaccination during pregnancy, visit CDC’s webpage, “COVID-19 Vaccines while Pregnant or Breastfeeding”: www.cdc.gov/coronavirus/2019-ncov/vaccines/recommendations/pregnancy.html.
Last reviewed:
March 19, 2024
Yes. COVID-19 vaccination is recommended for people who are lactating.
Last reviewed:
March 19, 2024
Please see CDC’s Interim Clinical Considerations for the Use of COVID-19 Vaccines for dosage guidance: www.cdc.gov/vaccines/covid-19/clinical-considerations/interim-considerations-us.html#immunocompromised..
People who are moderately or severely immunocompromised, who have not been vaccinated against COVID-19 in the past, and who are receiving the 2023–2024 Formula Novavax COVID-19 Vaccine should receive 2 doses spaced 3 to 8 weeks apart. They may receive a third dose at least 2 months after dose 2. As with mRNA COVID-19 vaccine recipients, they may receive additional doses at the discretion of their healthcare provider, based on their individual circumstances. CDC recommends that any additional doses be administered at least 2 months after the most recent 2023–2024 Formula dose.
Immunocompromised people should be counseled that they may have a reduced immune response to COVID-19 vaccination. They should be advised to continue other recommended infection prevention measures, such as wearing a face mask and avoiding crowds, to limit their risk of exposure to the SARS-CoV-2 virus.
Last reviewed:
March 19, 2024
The conditions and treatments that CDC specifies may result in moderate or severe immunocompromise include but are not limited to:
- Active treatment for solid tumor and hematologic malignancies
- Hematologic malignancies associated with poor responses to COVID-19 vaccines regardless of current treatment status (e.g., chronic lymphocytic leukemia, non-Hodgkin lymphoma, multiple myeloma, acute leukemia)
- Receipt of solid-organ transplant or an islet transplant and taking immunosuppressive therapy
- Receipt of chimeric antigen receptor (CAR)-T-cell therapy or hematopoietic cell transplant (HCT) (within 2 years of transplantation or taking immunosuppressive therapy)
- Moderate or severe primary immunodeficiency (e.g., common variable immunodeficiency disease, severe combined immunodeficiency, DiGeorge syndrome, Wiskott-Aldrich syndrome)
- Advanced HIV infection (people with HIV and CD4 cell counts less than 200/mm³, history of an AIDS-defining illness without immune reconstitution, or clinical manifestations of symptomatic HIV) or untreated HIV infection
- Active treatment with high-dose corticosteroids (i.e., 20 mg or more of prednisone or equivalent per day when administered for 2 or more weeks), alkylating agents, antimetabolites, transplant-related immunosuppressive drugs, cancer chemotherapeutic agents classified as severely immunosuppressive, tumor necrosis factor (TNF) blockers, and other biologic agents that are immunosuppressive or immunomodulatory (e.g., B-cell-depleting agents)
Additional factors to consider in assessing the general level of immune competence in a patient include disease severity, duration, clinical stability, complications, comorbidities, and any potentially immune-suppressing treatment. A patient’s clinical care team is in the best position to evaluate the degree of immunocompromise and timing of vaccination.
See CDC’s interim clinical considerations for this population: www.cdc.gov/vaccines/covid-19/clinical-considerations/interim-considerations-us.html#immunocompromised.
Last reviewed:
March 19, 2024
Yes. See all information about vaccination of immunocompromised people, including revaccination considerations after HCT and for those on B-cell depleting therapies, at www.cdc.gov/vaccines/covid-19/clinical-considerations/interim-considerations-us.html#immunocompromised. This is the most current statement from CDC on COVID-19 vaccination after HCT:
Recipients of HCT or CAR-T-cell therapy who received 1 or more doses of COVID-19 vaccine prior to or during treatment should be revaccinated. Revaccination should start at least 3 months (12 weeks) after transplant or CAR-T-cell therapy and should follow the currently recommended schedule for immunocompromised people who are unvaccinated.
A patient’s clinical team is best positioned to determine the degree of immune compromise, need for revaccination, and appropriate timing of revaccination.
Last reviewed:
March 19, 2024
According to CDC’s interim clinical considerations for the use of COVID-19 vaccines, whenever possible, COVID-19 vaccines should be administered at least 2 weeks before initiation or resumption of immunosuppressive therapies. For patients who receive B-cell-depleting therapies on a continuing basis, COVID-19 vaccines should be administered approximately 4 weeks before the next scheduled therapy.
CDC also notes that timing of COVID-19 vaccination should take into consideration current or planned immunosuppressive therapies, optimization of both the patient’s medical condition and response to vaccination, and individual benefits and risks. Review the CDC’s considerations for COVID-19 vaccination of those on immunosuppressive therapies here: www.cdc.gov/vaccines/covid-19/clinical-considerations/interim-considerations-us.html#considerations-timing-COVID-19-vaccination-immunosuppressive-therapies.
Last reviewed:
March 19, 2024
CDC states that no additional medical documentation is required before vaccination. People may simply affirm that they are moderately or severely immunocompromised and receive COVID-19 vaccine doses wherever vaccines are offered. Vaccinators should not deny COVID-19 vaccination to a person due to lack of documentation.
Last reviewed:
March 19, 2024
Immunocompromised people who require an initial series of 3 doses of mRNA COVID-19 vaccine or two doses of Novavax COVID-19 vaccine should receive the initial series using the same brand, unless it is not feasible. If the same brand (referred to as a homologous dose) cannot be used for all primary series doses (e.g., the brand is unavailable at the time of the vaccination visit, the previous brand is unknown, or the patient would not be vaccinated with the previous brand due to a contraindication or other reason), then administer another appropriate brand. CDC recommends homologous doses for all doses administered to children younger than age 5 years. If the immunocompromised recipient is age 5 years or older, once the initial series is complete, any appropriate brand may be used for subsequent doses. CDC provides additional information at: www.cdc.gov/vaccines/covid-19/clinical-considerations/interim-considerations-us.html#Interchangeability.
Last reviewed:
March 19, 2024
Primary vaccination with the Janssen COVID-19 Vaccine requires only a single dose. People who received the Janssen COVID-19 Vaccine primary dose require only one updated (2023–2024 Formula) dose by Moderna, Pfizer-BioNTech, or Novavax to be up to date. People who are moderately or severely immunocompromised have the option to receive 1 additional updated 2023–2024 Formula COVID-19 vaccine dose at least 2 months later. Further additional dose(s) may be administered, informed by the clinical judgment of a healthcare provider and personal preference and circumstances. Any further additional doses should be administered at least 2 months after the last 2023–2024 Formula COVID-19 vaccine dose.
To evaluate an immunocompromised individual’s COVID-19 vaccine needs based upon the person’s age and COVID-19 vaccination history, use this infographic from CDC: www.cdc.gov/vaccines/covid-19/downloads/COVID19-vaccination-recommendations-immunocompromised.pdf.
Last reviewed:
March 19, 2024
The patient should receive an updated 2023–2024 COVID-19 mRNA dose now, if feasible, of the same brand as the initial two doses, in order to complete the 3-dose primary mRNA vaccine series recommended for people with moderate or severe immunocompromise. Advise the patient that he has the option to receive additional 2023–2024 Formula COVID-19 doses of any brand (at least 2 months apart) as needed, based on his clinical circumstances.
To evaluate an immunocompromised individual’s COVID-19 vaccine needs based upon the person’s age and COVID-19 vaccination history, use this infographic from CDC: www.cdc.gov/vaccines/covid-19/downloads/COVID19-vaccination-recommendations-immunocompromised.pdf.
Last reviewed:
March 19, 2024
Yes. CDC states that people ages 6 months and older who are moderately or severely immunocompromised have the option to receive 1 additional dose of COVID-19 vaccine at least 2 months following the last recommended 2023–2024 Formula COVID-19 vaccine dose. Further additional dose(s) may be administered, informed by the clinical judgement of the healthcare provider and personal preference and circumstances. Any further additional doses should be administered at least 2 months after the last 2023–2024 COVID-19 vaccine dose.
To evaluate an immunocompromised individual’s COVID-19 vaccine needs based upon the person’s age and COVID-19 vaccination history, use this infographic from CDC: www.cdc.gov/vaccines/covid-19/downloads/COVID19-vaccination-recommendations-immunocompromised.pdf.
Last reviewed:
March 19, 2024
