FDA Shortens Booster Dose Interval for Moderna COVID-19 Vaccine

The Moderna booster dose is authorized for individuals 18 years of age and older.

The Food and Drug Administration (FDA) has updated the Emergency Use Authorization (EUA) for the Moderna COVID-19 vaccine to allow for the administration of a single booster dose in individuals 18 years of age and older at least 5 months after completion of the primary series. Previously, the interval between the primary series and the booster had been 6 months.

The updated EUA follows a similar decision the Agency made with the Pfizer-BioNTech COVID-19 vaccine. “The country is in the middle of a wave of the highly contagious Omicron variant, which spreads more rapidly than the original SARS-CoV-2 virus and other variants that have emerged,” said Peter Marks, MD, PhD, director of the FDA’s Center for Biologics Evaluation and Research. “Vaccination is our best defense against COVID-19, including the circulating variants, and shortening the length of time between completion of a primary series and a booster dose may help reduce waning immunity.” 

The most common adverse reactions reported following a booster dose of the Moderna COVID-19 vaccine were pain, redness, swelling at the injection site, fatigue, headache, muscle or joint pain and chills.

Updated fact sheets for the Moderna COVID-19 Vaccine are available here.

Reference

Coronavirus (COVID-19) update: FDA shortens interval for booster dose of Moderna COVID-19 vaccine to five months. News release. US Food and Drug Administration. Accessed January 7, 2022. https://www.prnewswire.com/news-releases/coronavirus-covid-19-update-fda-shortens-interval-for-booster-dose-of-moderna-covid-19-vaccine-to-five-months-301456242.html.

This article originally appeared on MPR