A second booster dose of either the Pfizer-BioNTech or Moderna COVID-19 vaccine has now been authorized for use in older adults and certain immunocompromised individuals, according to the Food and Drug Administration (FDA).
The Emergency Use Authorization (EUA) for both vaccines has been amended to include administration of a second booster dose to individuals 50 years of age and older at least 4 months after receipt of a first booster dose of any authorized or approved COVID-19 vaccine.
A second booster dose of the Pfizer-BioNTech COVID-19 vaccine may be administered at least 4 months after receipt of the first booster to immunocompromised patients 12 years of age and older (eg, those who have undergone solid organ transplantation or who are living with a condition considered an equivalent level of immunocompromise). Similarly, a second booster dose of the Moderna COVID-19 vaccine may be given to certain immunocompromised individuals at least 4 months after the first booster dose but is authorized for those 18 years of age and older.
The updated authorization was based on safety and immunogenicity data provided to the Agency by the Companies. According to 2 real-world data sets from Israel, no new safety concerns were reported with an additional booster dose of the Pfizer-BioNTech COVID-19 vaccine. Additionally, an independently conducted study in which the Moderna COVID-19 vaccine was given as a second booster dose to 120 participants showed no new safety concerns up to 3 weeks after the second booster.
Immunogenicity data from an open-label, nonrandomized clinical trial among health care workers at a single study center in Israel also showed an increase in neutralizing antibody levels against SARS-CoV-2 (including Delta and Omicron) 2 weeks after the second booster of the Pfizer-BioNTech COVID-19 vaccine as compared with 5 months after the first booster dose.
“Current evidence suggests some waning of protection over time against serious outcomes from COVID-19 in older and immunocompromised individuals,” said Peter Marks, MD, PhD, director of the FDA’s Center for Biologics Evaluation and Research. 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.”
Coronavirus (COVID-19) Update: FDA authorizes second booster dose of two COVID-19 vaccines for older and immunocompromised individuals. US Food and Drug Administration. News release. March 29, 2022. https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-authorizes-second-booster-dose-two-covid-19-vaccines-older-and