The U.S. Food and Drug Administration (FDA) has unanimously recommended an update to the COVID-19 vaccine formula for the upcoming fall booster campaign. This new formula aims to address the JN.1 variant, which is currently the predominant strain causing infections. Unlike previous boosters that targeted multiple variants, this new booster will be monovalent, focusing solely on the JN.1 variant.
The recommendation by the FDA’s independent advisory committee is now pending further approval within the FDA. This move aligns with the World Health Organization’s guidance to prioritize the JN.1 variant in COVID-19 vaccinations globally. Major vaccine manufacturers, including Pfizer, Moderna, and Novavax, have indicated their readiness to adapt to this new recommendation.
The push for a new booster comes amid declining COVID-19 hospitalization rates and deaths, with fewer than 300 deaths per week. However, there is a noted increase in hospitalizations and deaths during the winter months, particularly among individuals aged 65 and older. Despite these concerns, booster uptake remains low, with less than 23% of adults receiving the 2023 booster as of May 2024.
FDA official Jerry Weir acknowledged the challenge in determining the optimal timing for vaccine updates, highlighting the evolving nature of the virus and vaccination needs. The new booster strategy aims to provide better protection against current and future COVID-19 threats, especially as the colder season approaches.