The Food and Drug Administration (FDA) on Aug. 12 amended its emergency use authorizations (EUAs) for the Pfizer-BioNTech and Moderna COVID-19 vaccines to allow administration of an additional dose in moderately to severely immunocompromised people.
Because immunocompromised people are at increased risk of developing severe COVID-19, FDA recommends they receive a third vaccine dose at least 28 days after the initial two-dose regimen. The agency also recommends immunocompromised people discuss monoclonal antibody treatments with their health care provider if they contract or are exposed to COVID-19.
The Centers for Disease Control and Prevention (CDC)’s Advisory Committee on Immunization Practices also voted Aug. 13 to recommend an additional dose. Per CDC, moderately to severely immunocompromised people include those who:
- are receiving active cancer treatment for tumors or cancers of the blood;
- have received an organ transplant and are taking medicine to suppress the immune system;
- have received a stem cell transplant within the last two years or are taking medicine to suppress the immune system;
- have moderate or severe primary immunodeficiency, such as DiGeorge syndrome or Wiskott-Aldrich syndrome;
- have advanced or untreated human immunodeficiency virus infection; and
- are undergoing active treatment with high-dose corticosteroids or other drugs that might suppress immune response.
In light of FDA’s authorization of additional doses, CDC added new questions on vaccine doses to the National Healthcare Safety Network data collection forms. For technical support, hospitals should email NHSN@cdc.gov with ‘COVID-19 Vaccination Data Reporting’ in the subject line.
CDC will scheduled a Clinician Outreach and Communication Activity (COCA) Call on this decision on Aug. 17, from 2–3 pm ET. An event recording will be published on the COCA Call webpage.
CDC Recommends COVID-19 Vaccination for Pregnant, Breastfeeding People
CDC on Aug. 11 recommended COVID-19 vaccination for people who are pregnant, breastfeeding, or trying to become pregnant now or in the future.
The agency notes that pregnant and recently pregnant people are at increased risk for developing severe illness from COVID-19 compared with nonpregnant people. CDC stresses that no safety concerns were found in animal studies of the vaccines and that none of the vaccines cause COVID-19 infection. No adverse pregnancy outcomes were found in studies of vaccines that use the same viral vector as the Janssen COVID-19 vaccine.
The agency also notes that early reports on the safety of the molecular ribonucleic acid (mRNA) in pregnant people, including an analysis of data from three safety monitoring systems and an analysis of data from v-safe pregnancy registry enrollees, indicated no safety concerns for vaccinated people or their babies and no increased risk of data. Early data from a study in Israel suggest that receiving an mRNA vaccine during pregnancy reduces the risk for infection, and studies have shown that antibodies made after a pregnant person received an mRNA COVID-19 vaccine were found in umbilical cord blood and breast milk. Additional studies are underway to determine how COVID-19 vaccines affect pregnant people and their babies.