Clinical and Economic Impact of Differential COVID-19 Vaccine Effectiveness in the United States

  1. Michael Maschio
  2. Kelly Fust
  3. Amy Lee
  4. Nicolas Van de Velde
  5. Philip O. Buck
  6. Michele A. Kohli

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Abstract

Background

In the United States (US), three vaccines are currently available for primary vaccination and booster doses to prevent coronavirus disease 2019 (COVID-19), including the 2-dose messenger ribonucleic acid (mRNA) BNT162b2 (COMIRNATY®, Pfizer Inc) and mRNA-1273 (SPIKEVAX®, Moderna Inc) vaccines, which are preferred by the Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practice (ACIP), and the adenovirus vector Ad26.COV2.S (Johnson & Johnson) vaccine. A substantial body of evidence has now been published on the real-world effectiveness and waning of the primary series and booster doses against specific SARS-CoV2-variants. The study objective was to determine the clinical and economic impact of differences in effectiveness between mRNA-1273 and BNT162b2 booster vaccinations over one year (2022) in US adults ≥18 years.

Methods

A decision analytic model was used to compare three mRNA booster market share scenarios: (1) Current Scenario, where the booster mix observed in December 2021 continues throughout 2022; (2) mRNA-1273 Scenario, where the only booster administered in 2022 is mRNA-1273, and (3) BNT162b2 Scenario, where the only booster administered in 2022 is BNT162b2. Analyses were performed from the US healthcare system perspective. Sensitivity analyses were performed to explore the impact of COVID-19 incidence in the unvaccinated population and vaccine effectiveness (VE) on model results.

Results

In the Current Scenario, the model predicts 65.2 million outpatient visits, 3.4 million hospitalizations, and 636,100 deaths from COVID-19 in 2022. The mRNA-1273 Scenario reduced each of these outcomes compared to the Current Scenario. Specifically, 684,400 fewer outpatient visits, 48,700 fewer hospitalizations and 9,500 fewer deaths would be expected. Exclusive of vaccine costs, the mRNA-1273 Scenario is expected to decrease direct medical costs by $1.3 billion. Conversely, the BNT162b2 Scenario increased outcomes compared to the Current Scenario: specifically, 391,500 more outpatient visits, 34,500 more hospitalizations and 7,200 more deaths would be expected in 2022, costing an additional $946 million in direct medical costs. For both the mRNA-1273 and BNT162b2 booster scenarios, the percent change in direct treatment costs for COVID-19 is similar to the percent change in hospitalizations as the rate of hospitalizations is the driver of the overall costs.

Changing the number of projected COVID-19 cases in 2022 by varying the incidence rate has a direct effect on model outcomes. Higher incidence rates leads to higher outpatient visits, hospitalizations and deaths for all scenarios. Varying VE has an inverse effect on model outcomes. All outcomes increase when VE is lower for all vaccines and decrease when VE is higher. In all cases, additional use of mRNA-1273 leads to fewer infection outcomes while additional use of BNT126b2 results to higher infection outcomes.

Conclusion

As the real-world effectiveness evidence to date indicates that mRNA-1273 may be more effective at preventing COVID-19 infection and hospitalization over time than BNT-162b2, increasing the proportion of people receiving this as a booster are expected to reduce COVID-19-related outcomes and costs in 2022, regardless of COVID-19 incidence or variant.

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  1. ScreenIT

    SciScore for 10.1101/2022.03.31.22272957: (What is this?)

    Please note, not all rigor criteria are appropriate for all manuscripts.

    Table 1: Rigor

    NIH rigor criteria are not applicable to paper type.

    Table 2: Resources

    Software and Algorithms
    SentencesResources
    The model was developed in Microsoft Excel using Visual Basic for Applications (Microsoft Corp; Redmond, Washington).
    Microsoft Excel
    suggested: (Microsoft Excel, RRID:SCR_016137)
    1, 2020 in the Premier Healthcare COVID-19 Database.
    Premier Healthcare
    suggested: None

    Results from OddPub: We did not detect open data. We also did not detect open code. Researchers are encouraged to share open data when possible (see Nature blog).

    Results from LimitationRecognizer: We detected the following sentences addressing limitations in the study:
    As with all predictive modeling exercises, there are limitations to the study. Firstly, there is high uncertainty regarding the VE against emerging variants. Additionally, VE may increase as manufacturers tailor the vaccine to improve protection against new strains. Regardless of the variant, studies have shown higher VE for mRNA-1273 compared to BNT162b2, and therefore this relationship was maintained in our hypothetical VE profiles in the model for both primary and booster vaccinations. The base case analysis results assume VE similar to that estimated against an omicron-like variant. To address the uncertainty surrounding VE, different scenarios were tested. Assuming a high initial VE still resulted in the same trends as the base case; 100% mRNA-1273 boosters decreased, and 100% BNT162b2 boosters increased outpatient visits, hospitalization and deaths, compared to the booster mix. Assuming a low initial VE with double the monthly rate of waning compared to the base case also maintained the same trends as the base case. With lower overall effectiveness for all vaccines the number of cases and associated resource use is higher in all booster mix scenarios. The incidence of COVID-19 had to be projected over the upcoming year and is highly uncertain. Still, scenarios where a high incidence rate and low incidence rate were tested did not change the overall model results, with 100% mRNA-1273 boosters resulting in less outpatient visits, hospitalizations and costs compared to the...

    Results from TrialIdentifier: No clinical trial numbers were referenced.

    Results from Barzooka: We did not find any issues relating to the usage of bar graphs.

    Results from JetFighter: We did not find any issues relating to colormaps.

    Results from rtransparent:
    • Thank you for including a conflict of interest statement. Authors are encouraged to include this statement when submitting to a journal.
    • Thank you for including a funding statement. Authors are encouraged to include this statement when submitting to a journal.
    • No protocol registration statement was detected.

    Results from scite Reference Check: We found no unreliable references.

    About SciScore

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  2. Version published to 10.1101/2022.03.31.22272957v1 on medRxiv