ACIP June 2025: COVID-19 Trends, Vaccine Updates, and Targeted Recommendations

COVID-19 Epidemiology Update: Ongoing Burden in 2024–2025 Season

At the June 25, 2025, ACIP meeting, the CDC reported continued year-round circulation of SARS-CoV-2 across the US during the 2024–25 season. Estimates included 9.8–16.1 million illnesses, 270,000–440,000 hospitalizations, and 32,000–51,000 deaths. Hospitalization rates remain highest in infants under 6 months and adults over 65. Pediatric hospitalizations are largely concentrated in children under 2, most of whom had no underlying medical conditions. Notably, 1 in 4 hospitalized children required ICU care, and 89% were unvaccinated.

Though COVID-19 deaths have declined from the prior year, 70% still occurred in adults over 65. Official death certificate data likely undercounts mortality, with modeling suggesting higher figures. Pediatric COVID-19 deaths in children under 2 were comparable to flu-related deaths in the same group, but influenza continues to cause more deaths than COVID in older children.

Vaccination Strategy Shifts Toward Targeted Recommendations

Reflecting current epidemiologic trends, ACIP is transitioning from a universal COVID-19 vaccination strategy to more targeted recommendations. Vaccination for children is now advised through shared clinical decision-making with providers. Adults are encouraged to receive vaccination, and adults over 65 are recommended to get two COVID-19 vaccine doses annually. The committee is actively considering a move away from blanket policies toward population-specific guidance.

SARS-CoV-2 Genomics and 2025–26 Vaccine Composition

Genomic surveillance presented at the meeting showed that all circulating SARS-CoV-2 viruses are descendants of the JN.1 lineage. While two key changes have emerged in the virus’s binding domain compared to previous strains, overall similarity remains high. Based on this, the FDA approved a monovalent JN.1-targeted vaccine for the 2025–26 vaccination season. Effectiveness data for this updated formulation will be presented at a later time.

COVID-19 Vaccine Effectiveness (VE) for 2024–2025

Vaccine effectiveness was evaluated using data from three major CDC-supported surveillance platforms: VISION (covering over 300 emergency departments and 200 hospitals), Overcoming COVID (focusing on children across 20 sites), and IVY (using active enrollment). These studies used test-negative and prospective designs.

VE estimates focused on the added benefit of the current seasonal vaccine, regardless of past infection or vaccination. Coverage was suboptimal: under 15% of children, under 25% of adults, and 28% of adults over 65 received the 2024–25 vaccine; coverage among immunocompromised adults was 32%. VE was highest shortly after vaccination and waned over time. Maternal vaccination close to delivery provided stronger protection for infants. Across all groups, vaccines continued to offer meaningful protection against severe outcomes, including hospitalization and death.

COVID-19 Vaccine Safety Review: Strong Profile Maintained

The CDC reviewed its robust safety surveillance infrastructure, which includes VAERS (spontaneous reports), the Vaccine Safety Datalink (real-time EHR-based monitoring), the CISA Project (clinical consultation for complex cases), and V-SAFE (smartphone-based patient reporting). These systems are complemented by epidemiologic studies, pregnancy registries, and rapid signal detection protocols.

Of eight early safety signals detected, only myocarditis, mainly following a second booster dose, was confirmed as a vaccine-related adverse event. Fortunately, 90% of cases recovered within a year, and no deaths or cardiac transplants were reported. Current data show a very low risk of myocarditis in both children and adults.

Safety monitoring in pregnancy has shown no increased risk of adverse outcomes for women, pregnancy, or infants. Additional analyses also found no associations with abnormal uterine bleeding or tinnitus.

Importantly, death reports following mRNA COVID-19 vaccination were below expected rates, and most were attributed to common causes of death in the general population. CDC-led investigations using EHRs and autopsy data confirmed no increased mortality risk associated with COVID-19 vaccination.

Evidence Review and Committee Dynamics

Comprehensive evidence-to-recommendation review to ACIP, reinforcing continued support for COVID-19 vaccination in children, pregnant individuals, and older adults. The benefit–risk balance remains strongly in favor of vaccination, with only the rare, well-characterized risks of myocarditis and pericarditis noted. No new safety concerns have emerged.

While no vote on vaccine recommendations was held, due in part to changes in the ACIP working group’s composition, the presentation emphasized that protection against severe disease, hospitalization, and death remains the cornerstone rationale for COVID-19 vaccination. CDC staff were commended for handling critiques from newly appointed members, some of whom expressed divergent views on methodology and evidence interpretation. The committee’s ability to move toward consensus remains in flux, but the scientific case for targeted vaccination remains robust and clearly articulated.