The Next-Gen COVID Vaccine: A Targeted Rollout for High-Risk Groups
- Molly Li
- Sep 3
- 4 min read
The U.S. Food and Drug Administration (FDA) has approved new formulations of the COVID-19 vaccines for the 2025–26 season. Here's a closer look.
This year's update targets the LP.8.1 sublineage, part of the widely circulating JN.1 variant family. However, unlike previous rollouts, these approvals come with specific age and risk-based restrictions, meaning access will not be universal from the start.
Who can get the new shots?
Eligibility for the updated vaccines is currently limited to high-risk populations. The following approvals are for a single dose, recommended at least two months after a person's last COVID-19 shot:
Pfizer-BioNTech (Comirnaty LP.8.1): Approved for adults 65 and older, and for individuals aged 5–64 with at least one underlying condition that increases the risk of severe COVID-19. A single 0.3 mL dose is recommended, at least two months after the last COVID-19 shot.
Moderna (Spikevax LP.8.1): Approved for adults 65+, and for ages 6 months–64 with at least one underlying condition.
Moderna (mNEXSPIKE, next-gen mRNA-1283): Approved for adults 65+, and for ages 12–64 with one or more high-risk conditions, but only for those who have been previously vaccinated.
Novavax (Nuvaxovid LP.8.1): Approved for adults 65+, and for ages 12–64 with one or more high-risk conditions.
Their use is being strategically targeted toward groups where the benefit-to-risk ratio is considered strongest: older adults and those with medical conditions that increase their chances of severe disease.
What’s behind the age and risk cutoffs?
The FDA's decision is a direct reflection of the data submitted by the manufacturers. The initial applications for these vaccines highlighted efficacy and safety data primarily from older adults and individuals with specific health conditions.
This regulatory approach also follows guidance from the FDA's advisory committee, which earlier this year recommended that the 2025–26 vaccines be based on the LP.8.1 sublineage of JN.1. While these approvals are now in place, studies in broader, lower-risk populations are still ongoing.
Vaccine safety has been under continuous and close surveillance since 2020. According to the FDA's new labels, rare cases of myocarditis and pericarditis—inflammation of the heart or its lining—have been observed, particularly in younger males. While these events are generally mild and resolve with treatment, they remain a point of ongoing surveillance.
A 2023 review of vaccine safety research identified other rare adverse events, including:
Heart-related: arrhythmias and blood pressure changes
Circulatory/blood: thrombosis and anemia
Neurological: Guillain-Barré, acute disseminated encephalomyelitis, and facial paralysis
Skin/immune: allergic reactions and rashes
Renal or muscular: kidney inflammation and rhabdomyolysis
Critically, the review consistently emphasized that these events occur at very low rates, often just a few cases per million doses, and that the risk of severe complications from COVID-19 infection remains significantly higher.
What This Means Going Forward
According to company announcements, the updated vaccines are expected to become available in pharmacies, hospitals, and clinics in the coming days. The Centers for Disease Control and Prevention (CDC) has yet to release detailed recommendations on how these approvals will be implemented.
For now, eligibility is limited to older adults and individuals with specific health conditions. Broader use may depend on the results of ongoing studies and future regulatory decisions. Reports of rare adverse events will continue to be closely monitored by national and global health authorities, with regulators adapting their safety surveillance as new data emerges. The situation is still developing, and the next steps will be shaped by evolving evidence and updated public health guidance.
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