Second Booster Approved for Select Groups of the Population
By: Emily H. Lineweaver
On March 29, 2022, the U.S. Food and Drug Administration (FDA) authorized a second booster dose of either the Pfizer-BioNTech or Moderna COVID-19 vaccine for two select groups of individuals: (i) those 50 years of age and older; and (ii) those 12 years of age and older who are immunocompromised, which is defined as “people who have undergone solid organ transplantation, or who are living with conditions that are considered to have an equivalent level of immunocompromise.” A second booster dose is recommended for these individuals at least 4 months after receipt of a first booster dose of any of the approved COVID-19 vaccines. Following the FDA’s announcement, the Centers for Disease Control and Prevention (CDC) updated its recommendation, which mirrors the FDA’s.
Peter Marks, M.D., Ph.D., and Director of the FDA’s Center for Biologics Evaluation and Research stated that “[c]urrent evidence suggests some waning of protection over time against serious outcomes from COVID-19 in older and immunocompromised individuals. Based on an analysis of emerging data, a second booster dose of either the Pfizer-BioNTech or Moderna COVID-19 vaccine could help increase protection levels for these higher-risk individuals.”
Both the FDA and the CDC will continue to evaluate whether expanding the eligibility for a second booster dose to the broader population is necessary.