The Food and Drug Administration (FDA) on Oct. 20 amended its emergency use authorization (EUA) for COVID-19 vaccines. The EUA now includes a booster dose of the Moderna and Janssen vaccines; allows the use of a heterologous booster dose after primary vaccination with a different vaccine; and clarifies populations eligible for a Pfizer-BioNTech booster dose.
A booster dose of the Moderna COVID-19 vaccine — half the dose of each shot in the primary series — may be administered at least six months after completing the primary series to people:
- ages 65 and older;
- ages 18 to 64 at risk of developing severe COVID-19; and
- with frequent institutional or occupational exposure to SARS-CoV-2.
A booster dose of the Janssen COVID-19 vaccine may be administered at least two months after the original single-dose vaccine to those ages 18 and older.
Additionally, the agency authorized the use of heterologous booster shots (also known as “mix and match” shots) following a primary vaccination series with a different COVID-19 vaccine, citing data from a National Institute for Allergy and Infectious Diseases clinical trial. Individuals should follow the booster eligibility criteria for the vaccine used for primary vaccination.
FDA also clarified that a single booster dose of the Pfizer-BioNTech COVID-19 vaccine may be administered at least six months after finishing the primary series to individuals ages 18 to 64 with frequent institutional or occupational exposure to SARS-CoV-2.
The original Sept. 22 EUA only authorized a booster dose to those whose frequent institutional or occupational exposure presented high risk. This aligns with the booster recommendations for the Moderna vaccine.
The Centers for Disease Control and Prevention (CDC) Advisory Committee on Immunization Practices on Oct. 21 recommended booster shots for all three vaccines in alignment with FDA authorization.
Biden Administration Releases Plan to Vaccinate Children
Ahead of an Oct. 26 FDA advisory committee meeting to discuss authorizing the Pfizer COVID-19 vaccine for children ages five to 11, the Biden administration announced its operational plan for vaccinating children.
Pending FDA authorization, the Pfizer vaccine will come in a smaller configuration — 10-dose vials in cartons of 10 vials each — with smaller needles and other supplies to serve children. The vaccine will be delivered in a new shipper that enables storage for up to 10 weeks at standard refrigeration temperatures and six months at ultracold temperatures.
The administration is working to establish vaccine sites at more than 25,000 pediatrician offices and primary care sites, hundreds of community health centers and rural health clinics, and more than 100 children’s hospitals. Tens of thousands of pharmacies nationwide will offer vaccine clinics at family-friendly hours. The Federal Emergency Management Agency will provide funding for school- and community-based clinics, and a new initiative will match school districts with vaccine providers to provide on-site vaccination clinics.
The Department of Health and Human Services (HHS) will launch a culturally responsive public education campaign for parents and guardians, mobilizing more than 14,000 members of the COVID-19 Community Corps. Recognizing that not all children have a primary care provider, HHS will work with pediatricians and community leaders to visit hard-hit, high-risk communities.
CDC Updates List of Underlying Conditions Associated with High COVID-19 Risk
Meanwhile, CDC updated the list of underlying medical conditions that increase risk for severe illness from SARS-CoV-2 for adults of any age, citing new evidence from published reports, scientific articles in press, unreviewed preprints, and internal data. An Oct. 14 CDC brief cites the evidence used to determine inclusion of new conditions.
The list now includes:
- chronic lung diseases, such as bronchiectasis, bronchopulmonary dysplasia, interstitial lung disease, pulmonary hypertension, pulmonary embolism, and tuberculosis;
- chronic liver diseases, such as cirrhosis, non-alcoholic fatty liver disease, alcoholic liver disease, and autoimmune hepatitis; and
- mental health disorders, such as mood disorders including depression, and schizophrenia spectrum disorders.
Visit the America’s Essential Hospitals coronavirus resource page for more information about the pandemic.
Contact Senior Director of Policy Erin O’Malley at email@example.com or 202.585.0127 with questions.