Annual vaccination campaign with second dose protects high-risk groups from SARS-CoV-2 and may save health care costs

Embargoed for release until 5:00 p.m. ET on Monday 25 March 2024   
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Below please find summaries of new articles that will be published in the next issue of Annals of Internal Medicine. The summaries are not intended to substitute for the full articles as a source of information. This information is under strict embargo and by taking it into possession, media representatives are committing to the terms of the embargo not only on their own behalf, but also on behalf of the organization they represent.   
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1. Annual vaccination campaign with second dose protects high-risk groups from SARS-CoV-2 and may save health care costs

Abstract: https://www.acpjournals.org/doi/10.7326/M23-2451  

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Implementing an annual vaccination campaign, coupled with administering a second dose to children under 2 years old and individuals aged 50 and over, could serve as an effective strategy in safeguarding against SARS-CoV-2 infection and its associated consequences. The research underscores the significance of closely monitoring seasonal and evolutionary trends of the virus to guide vaccination strategies and the continual evolution of vaccines. The study is published in Annals of Internal Medicine.

The FDA has proposed annual, single-dose vaccination for SARS-CoV-2, like influenza vaccination, with a potential second dose for those at risk for severe outcomes, including children younger than 2 years and adults aged 50 years or older. Over time, COVID-19 infection patterns may occur annually like influenza. Establishing patterns of widespread vaccination prior to these annual cycles may reduce disease burden. However, the effectiveness of this strategy remains undetermined, with unknown timing of a surge and the possibility of semiannual COVID-19 epidemics.

Researchers from Yale School of Public Health conducted an analysis of an age-structured dynamic model of infectious disease transmission calibrated to replicate winter and late summer peaks in COVID-19 hospitalization. The authors found that the FDA’s proposed schedule of annual vaccination with a second dose for older adults and young children was associated with fewer hospitalizations, fewer deaths, and less health care spending each year. The optimal timing for this second vaccination would be delivered 5 months after initial vaccination. However, should epidemiologic trends of SARS-CoV-2 fully adopt seasonal dynamics, the significance of a second dose in mitigating disease burden could diminish.

Media contacts: For an embargoed PDF, please contact Angela Collom at acollom@acponline.org. To speak with the corresponding author, Alison P. Galvani, PhD, please contact alison.galvani@yale.edu.

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2. Caps on insulin out-of-pocket costs increases use only in some groups

Abstract: https://www.acpjournals.org/doi/10.7326/M23-1965  

URL goes live when the embargo lifts    

A pre-post study of states with insulin out-of-pocket (OOP) cost caps found that OOP caps were associated with reduced insulin cost but not increased insulin use. The study is published in Annals of Internal Medicine.

Since 2020, 25 states have capped insulin OOP costs at $25 to $100 for a 30-day supply for residents in commercial health plans. Data about the effectiveness of state insulin caps can inform state and federal policymaking, but the effect of state insulin caps on OOP costs and use among commercially insured populations is uncertain.

Researchers from Harvard Medical School and Harvard Pilgrim Health Care Institute conducted a pre-post study with control group of commercially insured, insulin-using persons under 65 years of age. Subgroups of particular interest included members from states with insulin OOP caps of $25 to $30, enrollees with health savings accounts (HSAs) that require high insulin OOP payments, and lower-income members. The authors found that state insulin caps were associated with 17.4 percent relative decrease in consumer OOP costs primarily among persons with HSAs. The authors note that persons living in states with $25 to $30 caps experienced a 40% reduction in OOP costs. While insulin use remained constant in almost all subgroups, they observed an increase in insulin use among lower-income patients with diabetes in HSA plans in states with $25 to $30 caps. According to the authors, their findings suggest that the proposed national $35 insulin cap for commercially insured persons would have a small effect on OOP costs for most affected insulin users and would not broadly increase insulin use. They suggest that other policies might be needed to improve access to affordable insulin among commercially insured patients with diabetes who have cost-related underuse.

Media contacts: For an embargoed PDF, please contact Angela Collom at acollom@acponline.org. To speak with the corresponding author, Laura F. Garabedian, PhD, please contact laura.garabedian@post.harvard.edu.

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3. Deep-learning model predicts 10-year cardiovascular event risk with single radiograph image

Abstract: https://www.acpjournals.org/doi/10.7326/M23-1898  

URL goes live when the embargo lifts    

A risk prediction study of cardiovascular disease prevention efforts found that the use of a deep-learning model better predicts 10-year risk for major adverse cardiovascular events (MACE) beyond the current clinical risk score, even for patients whose score cannot be calculated due to missing data. The study is published in Annals of Internal Medicine.

Guidelines from the American College of Cardiology and American Heart Association on the primary prevention of atherosclerotic cardiovascular disease (ASCVD) recommend a risk calculator for nondiabetic adults aged 40 to 75 years with low-density lipoprotein cholesterol levels between 1.81 and 4.91 mmol/L (between 70 and 190 mg/dL) to estimate the 10-year risk for ASCVD as a guide to pharmacologic and other primary prevention. However, because the necessary input variables to calculate the ASCVD risk score are often not available in the electronic medical record, other approaches for population-based screening are desirable to identify individuals at high risk who are likely to benefit from a statin.

Researchers from Massachusetts General Hospital and Harvard Medical School conducted a risk prediction study of a deep-learning model (CXR CVD-Risk) that estimates 10-year risk for MACE from a routine chest radiograph (CXR). The model was validated using data from 8,869 outpatients with unknown ASCVD risk because of missing inputs to calculate the ASCVD risk score and in 2,132 outpatients with known risk whose ASCVD risk score could be calculated. The authors found that, for the 81 percent of patients who had unknown ASCVD risk due to missing inputs to calculate the traditional ASCVD risk score, 10-year risk for incident MACE was 1.5-fold higher for persons identified as statin-eligible by CXR CVD-Risk than for those classified as ineligible, independent of available baseline cardiovascular risk factors. They also found that for the 19 percent of patients who had all necessary inputs available to calculate the traditional, guideline-recommended ASCVD risk score, CXR CVD-Risk had similar performance and additive value to the traditional risk score. According to the authors, their findings suggest that CXR CVD-Risk could enable population-based opportunistic screening using routine CXRs to identify persons at high risk who would benefit from primary ASCVD prevention with statins but are currently unrecognized.

Media contacts: For an embargoed PDF, please contact Angela Collom at acollom@acponline.org. To speak with the corresponding author, Jakob Weiss, MD, please contact Noah Brown at nbrown9@mgb.org.

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