Fall 2024 COVID Vaccine: FDA Panel Recommendation
- COVID-19 vaccines for the 2025-2026 respiratory virus season should target the JN.1 lineage of SARS-CoV-2, an FDA committee recommended Thursday.The Vaccines and Related Biological Products Advisory Committee (VRBPAC)...
- the committee considered targeting LP.8.1, a dominant viral variant in the U.S.descended from JN.1.Archana Chatterjee, MD, PhD, a VRBPAC voting member from Rosalind Franklin University of Medicine...
- While JN.1 is not currently circulating in the U.S., its subvariants, including LP.8.1 (about 70% of cases) and XFC (9%), are the dominant strains, according to...
An FDA advisory panel has decisively recommended that future COVID vaccines for the 2025-2026 season should target the JN.1 lineage, with a specific focus on its subvariants like LP.8.1, currently dominant in the U.S. This proactive stance, aimed at improving protection, comes as health officials prepare for updated formulations of the COVID vaccines. The committee’s unanimous vote reflects a commitment to adapting swiftly to evolving viral strains and offers an critically importent update. News Directory 3 brings you the latest on these developments, including the challenges of predicting dominant strains and the FDA’s direction to vaccine manufacturers. with future COVID-19 vaccines potentially limited to specific at-risk groups, what does this recommendation mean for you? Discover what’s next …
FDA Panel Recommends JN.1 Strain for 2025-26 COVID Vaccines
Updated May 26, 2025
COVID-19 vaccines for the 2025-2026 respiratory virus season should target the JN.1 lineage of SARS-CoV-2, an FDA
committee recommended Thursday.The Vaccines and Related Biological Products Advisory Committee (VRBPAC) voted
unanimously in favor of a monovalent vaccine focused on viruses from this lineage. This recommendation for
COVID vaccines comes as health officials prepare for updated formulations.
An FDA committee on Thursday voted on what strain 2025-2026 COVID-19 vaccines should be aimed at.
Image: Adobe Stock
the committee considered targeting LP.8.1, a dominant viral variant in the U.S.descended from JN.1.Archana
Chatterjee, MD, PhD, a VRBPAC voting member from Rosalind Franklin University of Medicine and Science, noted
the similarity to last year’s decision to stay with JN.1 despite other emerging variants. She said that even
though LP.8.1 may not be the dominant variant in the fall,it is the closest available target.
While JN.1 is not currently circulating in the U.S., its subvariants, including LP.8.1 (about 70% of cases) and
XFC (9%), are the dominant strains, according to the CDC and FDA. Committee members acknowledged that SARS-CoV-2
mutates continuously, unlike seasonal viruses such as influenza. This continuous mutation presents challenges in
predicting future dominant strains for COVID vaccines.
jerry Weir, PhD, director of the division of viral products in the FDA’s Office of Vaccines Research and Review,
said the time required to produce updated vaccines poses challenges to frequent updates. Saad B. Omer, MBBS, MPH,
PhD, a VRBPAC member from UT Southwestern Medical Center, added that the timing of vaccine availability is
critical, especially for viruses without a clear seasonal pattern.
The FDA recently approved Novavax’s protein-based COVID-19 vaccine, the onyl approved non-mRNA option, with some
restrictions. The agency also announced that future COVID-19 vaccines will be limited to specific groups,
including older adults and those with risk factors for severe disease. For individuals aged 6 months to 64 years
without risk factors, the FDA will require data from randomized controlled trials before approval.
Additionally, the FDA has directed Pfizer/BioNTech and Moderna to expand warning labels on their vaccines
regarding the risk of myocarditis and pericarditis, rare heart conditions that can occur post-vaccination.
What’s next
The FDA’s decision to focus on the JN.1 lineage for the upcoming COVID vaccines aims to provide the best
possible protection against current and emerging variants, while balancing the practical challenges of vaccine
growth and distribution.