The U.S. Food and Drug Administration (FDA) amended the emergency use authorizations (EUAs) for both the Moderna and Pfizer-BioNTech COVID-19 vaccines to authorize the use of a single booster dose for everyone 18 years of age and older.
People would be eligible for the booster dose at least six months after completion of primary vaccination with the Moderna COVID-19 vaccine or Pfizer-BioNTech COVID-19 vaccine or at least two months after completion of primary vaccination with the Johnson & Johnson COVID-19 vaccine.
The Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices is scheduled to meet later Friday to discuss whether to recommend expanding eligibility for the COVID-19 vaccines to align with the FDA’s EUAs.
Prior to the change in authorization on Friday, a single booster dose of the Moderna and Pfizer-BioNTech COVID-19 vaccines was authorized for certain groups, including people: 65 years of age and older, 18-64 years of age at high risk of severe COVID-19, and 18-64 years of age with frequent institutional or occupational exposure to SARS-CoV-2.
“The FDA has determined that the currently available data support expanding the eligibility of a single booster dose of the Moderna and Pfizer-BioNTech COVID-19 vaccines to individuals 18 years of age and older,” said Peter Marks, MD, PhD, Director of the FDA’s Center for Biologics Evaluation and Research.
The EUA for a single booster dose 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 that supported the use in the previously authorized populations for boosters, the FDA said.
For the Moderna COVID-19 vaccine booster dose, the FDA analyzed the immune response data from 149 participants 18 years of age and older from the original clinical studies who received a booster dose at least six months after their second dose and compared it to the immune responses of 1,055 study participants after completing their two-dose series. The results showed an antibody response against the SARS-CoV-2 virus 29 days after a booster dose of the vaccine.
For the Pfizer-BioNTech COVID-19 vaccine booster dose, the FDA analyzed the immune response data from approximately 200 participants 18-55 years of age who received a single booster dose about six months after their second dose. When compared to the response one month after the two-dose primary series in the same people, the results showed an antibody response against the SARS-CoV-2 virus one month after a booster dose of the vaccine.
