The FDA amended the emergency use authorization (EUA) for both the Moderna and Pfizer-BioNTech COVID-19 vaccines authorizing use of a single booster dose for all individuals 18 years of age and older after completion of the primary vaccination with any FDA authorized or approved COVID-19 vaccine.
Previously, a single booster dose of the Moderna and Pfizer-BioNTech COVID-19 vaccines was authorized for individuals 65 years of age and older, individuals 18 to 64 year of age who are at high risk of severe COVID-19, and individuals 18 through 64 years of age with frequent institutional or occupational exposure to SARS-CoV-2. The expansion of the EUA booster doses includes all individuals 18 years of age and older at least 6 months after completion of the primary vaccination series of the Moderna COVID-19 vaccine or Pfizer-BioNTech COVID-19 vaccine, or at least 2 months after completion of the primary vaccination with the Janssen COVID-19 vaccine.
The FDA’s EUA approval for a single booster dose for individuals 18 years of age and older for the Moderna (administered as half of the dose of a primary series dose) and Pfizer-BioNTech COVID-19 vaccines is based on the FDA’s analysis of immune response data supporting use in the previously authorized population for boosters.
For Pfizer, the FDA reviewed immunogenicity data from approximately 200 participants ages 18 to 55 years. The phase 3 trial found that the booster dose was safe and demonstrated a relative 95.6% efficacy versus those who had only received a two-dose primary series. Moderna’s EUA was granted on the basis of immunogenicity data from a phase 2 trial of 149 adults who received the two-dose 100-μg series plus the booster dose, which the FDA said demonstrated a booster response. The agency notes the increased risk of vaccine-associated myocarditis and pericarditis, but states that the benefits of a single booster dose outweigh the risks in adults ages 18 and up.
