Novavax, a pharmaceutical company, is awaiting a decision from the US Food and Drug Administration (FDA) on whether its next COVID-19 vaccine can be offered in the United States. The vaccine targets a variant called JN.1, which is in line with European recommendations. The European Union's regulator has advised vaccine manufacturers to update their vaccines for this variant, as they are likely to be effective against its descendant lineages. However, the FDA has not yet made a decision on the composition of the next round of COVID-19 vaccines. In the past month, a subvariant of JN.1 known as KP.2 has become dominant in the United States. Novavax's protein-based vaccine is developed in moth cells and takes months to manufacture, unlike mRNA vaccines from Moderna and Pfizer, which can be developed more quickly. Novavax recently signed a licensing deal worth at least $1.2 billion for its COVID-19 vaccine. The company expects revenue in the range of $400 million to $600 million in 2024, significantly lower than the $983.7 million it recorded last year. Regulators have been urging vaccine makers to design new versions of COVID-19 vaccines to better target currently circulating variants since 2022. The FDA has postponed its vaccine advisory meeting to gather more surveillance data and information on the circulating virus. The U.S. FDA staff recommends that COVID-19 shots for the 2024-2025 campaign should target the JN.1 variant and JN.1-derived subvariants such as KP.2. The FDA reviewers believe that vaccines developed against JN.1 may adequately protect against KP.2 due to the minimal difference between the two. However, they also suggest that vaccine makers should consider updating their vaccine to the currently predominant variant in case the virus further evolves away from JN.1. The U.S. Centers for Disease Control and Prevention estimates that the KP.2 subvariant accounts for about 28.5% of COVID-19 cases in the United States. [987bd542] [84020356]