The FDA’s expert advisory committee has made a critical recommendation to update COVID-19 vaccines to better address the current circulating strains of the virus, particularly those related to the JN.1 variant. This recommendation comes at a time when concerns over newer, more transmissible subvariants are growing, despite overall declining trends in COVID-19 hospitalizations since the peak of the pandemic. The updated vaccines would be designed to improve immunity against strains increasingly common in the United States, in an effort to provide continued protection against COVID-19 for vulnerable populations.
In the last several years, the U.S. has witnessed significant shifts in its approach to COVID-19 vaccination, influenced by changes in both virus variants and government policy. Following major policy adjustments during the Trump administration, access to vaccines was restricted to certain age groups, primarily individuals aged 65 and older, and those at high risk of severe disease. Additionally, the administration mandated that placebo-controlled trials be conducted for healthy individuals under the age of 65. These decisions were based on concerns over vaccine safety and efficacy, as well as the shifting understanding of the virus’s impact on different demographics.
While the country has made significant strides in fighting the virus, with vaccination rates reaching high levels and hospitalizations dropping since the 2021-2022 period, COVID-19 remains a public health threat. According to the Centers for Disease Control and Prevention (CDC), an estimated 30,000 to 50,000 people have died from COVID-19, and between 300,000 to 430,000 individuals have been hospitalized due to the virus since October 2024. These figures demonstrate that the virus continues to cause significant morbidity and mortality, particularly in vulnerable populations.
The CDC also highlighted that most of the circulating COVID-19 strains in the U.S. are descendants of the JN.1 variant, although the emergence of new subvariants, such as BA.3.2, has sparked concerns among health experts. These subvariants share similarities with earlier strains but have mutations that make them more transmissible or potentially capable of evading immunity developed through prior infection or vaccination. As a result, the FDA’s advisory committee emphasized the importance of keeping the vaccine updated to reflect these evolving strains and maintain robust immunity in the population.
The committee’s recommendation comes at a time when infection-induced immunity is beginning to wane. Data from the CDC shows that while initial immunity gained from infection or vaccination is strong, its protective effects diminish over time. This highlights the need for booster shots and updated vaccines to ensure that individuals, especially those at high risk, continue to receive optimal protection against severe illness and hospitalization. The idea of “vaccine fatigue” has also emerged as a concern, with some individuals hesitant to receive booster shots, especially with the perception that the virus is less of a threat due to declining case numbers. However, experts stress that the risk of severe outcomes remains, especially as new variants continue to emerge.
The FDA typically follows the guidance of its advisory committees, so it is likely that updated vaccines targeting the newer JN.1-related strains will be available for the 2025-2026 period. Health authorities have also expressed that ongoing surveillance of the virus, in conjunction with vaccine adjustments, will be necessary to stay ahead of emerging variants and ensure that public health measures remain effective.
Despite the challenges that remain, the fight against COVID-19 is far from over. With updated vaccines, continued public health efforts, and evolving strategies to address new variants, the U.S. will likely remain vigilant in its battle against the virus, ensuring that the population is well-protected as we move further into the post-pandemic era.
