The EUA allows the booster shot to be given after primary vaccination with any FDA-authorized or approved COVID-19 vaccine
Following the FDA’s decision on Friday, the Centers for Disease Control and Prevention (CDC) expanded its recommendations for booster shots to include all adults 18+ at least six months after the second dose of the primary series.
Streamlining eligibility
The FDA’s previous authorization for booster shots, issued in September, had been limited to people aged 65+ and high-risk individuals.
Aside from providing reinforced protection against COVID-19 to a far larger population, the FDA hopes the wider authorization will remove any confusion around eligibility.
“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, M.D., Ph.D., director of the FDA’s Center for Biologics Evaluation and Research.
“Streamlining the eligibility criteria and making booster doses available to all individuals 18 years of age and older will also help to eliminate confusion about who may receive a booster dose and ensure booster doses are available to all who may need one.”
The EUA 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 that supported use in the previously authorized populations for boosters.
Moderna booster: the FDA analyzed the immune response data from 149 participants aged 18+ 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 antibody response against the SARS-CoV-2 virus 29 days after a booster dose of the vaccine demonstrated a booster response.
Pfizer booster: the FDA analyzed the immune response data from approximately 200 participants 18 through 55 years of age who received a single booster dose about six months after their second dose. The antibody response against the SARS-CoV-2 virus one month after a booster dose of the vaccine when compared to the response one.