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● The U.S. Food and Drug Administration (FDA) expanded the Emergency Use Authorization (EUA) for the Moderna COVID-19 vaccine on October 20, 2021 to include a booster dose six months after completion of the primary series for certain populations. ● The FDA expanded the Emergency Use Authorization (EUA) for the Johnson & Johnson (J&J)/Janssen COVID-19 vaccine on October 20, 2021 to include a booster dose two months after completion of the primary series. ● The FDA amended the Emergency Use Authorizations (EUAs) for the Pfizer and Moderna COVID-19 vaccines on November 19, 2021 to expand the populations eligible for a booster (details below). ● The FDA also authorized heterologous (“mix and match”) booster doses for all three COVID-19 vaccines (Pfizer, Moderna, and J&J) when the same vaccine used for the primary series is not available or there are individual risk/benefit considerations (details below). ● Centers for Disease Control and Prevention (CDC) Advisory Committee on Immunization Practices (ACIP) issued recommendations for all COVID-19 vaccine booster doses on October 22, 2021, and November 19, 2021. CDC expanded the recommendations for COVID-19 booster doses on November 29, 2021 to recommend that everyone ages 18 years and older should receive a COVID-19 booster dose (previously the recommendation for some individuals was “may” receive a booster; details below). ● CDC issued Emergency Use Instructions for the Pfizer COVID-19 vaccine; recipients of a primary vaccine series not authorized/approved in the United States should receive a single additional dose (for individuals ≥12 years with moderately to severely immunocompromising conditions) or a single booster dose (for certain individuals ≥18 years) (details below). The Pfizer COVID-19 vaccine is the only vaccine approved for use as an additional dose or booster dose for individuals who received a primary series vaccine that is not authorized or approved in the United States. ● CDC recommends that people with moderately to severely compromised immune systems receive an additional dose of mRNA COVID-19 vaccine at least 28 days after a second dose of Pfizer-BioNTech COVID-19 vaccine or Moderna COVID-19 vaccine to complete the primary series. Moderately to severely immunocompromised individuals are also eligible to receive a booster dose of any vaccine product ((Pfizer-BioNTech, Moderna, or J&J) at least six months after receiving their third mRNA vaccine dose. ● The booster dose volume for the Moderna COVID-19 vaccine is a half dose, or 0.25 ml (50μg). This is different from the full dose volume of 0.5 ml (100μg) used in the primary series. ● The FDA authorized use of an age-appropriate dose of the Pfizer vaccine on October 29, 2021 for children aged 5-11 years. ACIP issued a recommendation on November 2, 2021 for all children aged 5-11 years to receive the vaccine. ● All individuals are still considered fully vaccinated two weeks after completing the primary series of any authorized COVID-19 vaccine.
● CDC’s webpage for Interim Clinical Considerations for the Use of COVID-19 Vaccines (https://www.cdc.gov/vaccines/covid-19/clinical-considerations/covid-19-vaccines-us.html) has been updated to reflect these recommendations. |
