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      Maternal Vaccine Effectiveness Against Influenza-Associated Hospitalizations and Emergency Department Visits in Infants

      Author(s): 1 , 2 , 3 , 3 , 4 , 4 , 5 , 5 , 6 , 6 , 7 , 7 , 8 , 9 , 1 , 2 , 1 , 10 , 10 , 10 , 10 , 10 , 10 , 10 , 10 , 10 , 10 , 10 , 10 , 10 , New Vaccine Surveillance Network Collaborators
      Publication date (Electronic):
      Journal: JAMA Pediatrics
      Publisher: American Medical Association (AMA)

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          Abstract

          Importance

          Influenza virus infection during pregnancy is associated with severe maternal disease and may be associated with adverse birth outcomes. Inactivated influenza vaccine during pregnancy is safe and effective and can protect young infants, but recent evidence, particularly after the 2009 novel influenza A (H1N1) pandemic, is limited.

          Objective

          To evaluate the effectiveness of influenza vaccination during pregnancy against laboratory-confirmed influenza-associated hospitalizations and emergency department (ED) visits in infants younger than 6 months.

          Design, Setting, and Participants

          This was a prospective, test-negative case-control study using data from the New Vaccine Surveillance Network from the 2016 to 2017 through 2019 to 2020 influenza seasons. Infants younger than 6 months with an ED visit or hospitalization for acute respiratory illness were included from 7 pediatric medical institutions in US cities. Control infants with an influenza-negative molecular test were included for comparison. Data were analyzed from June 2022 to September 2023.

          Exposure

          Maternal influenza vaccination during pregnancy.

          Main Outcomes and Measures

          We estimated maternal vaccine effectiveness against hospitalizations or ED visits in infants younger than 6 months, those younger than 3 months, and by trimester of vaccination. Maternal vaccination status was determined using immunization information systems, medical records, or self-report. Vaccine effectiveness was estimated by comparing the odds of maternal influenza vaccination 14 days or more before delivery in infants with influenza vs those without.

          Results

          Of 3764 infants (223 with influenza and 3541 control infants), 2007 (53%) were born to mothers who were vaccinated during pregnancy. Overall vaccine effectiveness in infants was 34% (95% CI, 12 to 50), 39% (95% CI, 12 to 58) against influenza-associated hospitalizations, and 19% (95% CI, −24 to 48) against ED visits. Among infants younger than 3 months, effectiveness was 53% (95% CI, 30 to 68). Effectiveness was 52% (95% CI, 30 to 68) among infants with mothers who were vaccinated during the third trimester and 17% (95% CI, −15 to 40) among those with mothers who were vaccinated during the first or second trimesters.

          Conclusions and Relevance

          Maternal vaccination was associated with reduced odds of influenza-associated hospitalizations and ED visits in infants younger than 6 months. Effectiveness was greatest among infants younger than 3 months, for those born to mothers vaccinated during the third trimester, and against influenza-associated hospitalizations.

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          Most cited references36

          • Record: found
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          Bias reduction of maximum likelihood estimates

          David G. Firth (1993)
          Article 0 comments Cited 439 times – based on 0 reviews     Review now
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            Simulation study of confounder-selection strategies.

            George Maldonado, Sander Greenland (1993)
            In the absence of prior knowledge about population relations, investigators frequently employ a strategy that uses the data to help them decide whether to adjust for a variable. The authors compared the performance of several such strategies for fitting multiplicative Poisson regression models to cohort data: 1) the "change-in-estimate" strategy, in which a variable is controlled if the adjusted and unadjusted estimates differ by some important amount; 2) the "significance-test-of-the-covariate" strategy, in which a variable is controlled if its coefficient is significantly different from zero at some predetermined significance level; 3) the "significance-test-of-the-difference" strategy, which tests the difference between the adjusted and unadjusted exposure coefficients; 4) the "equivalence-test-of-the-difference" strategy, which significance-tests the equivalence of the adjusted and unadjusted exposure coefficients; and 5) a hybrid strategy that takes a weighted average of adjusted and unadjusted estimates. Data were generated from 8,100 population structures at each of several sample sizes. The performance of the different strategies was evaluated by computing bias, mean squared error, and coverage rates of confidence intervals. At least one variation of each strategy that was examined performed acceptably. The change-in-estimate and equivalence-test-of-the-difference strategies performed best when the cut-point for deciding whether crude and adjusted estimates differed by an important amount was set to a low value (10%). The significance test strategies performed best when the alpha level was set to much higher than conventional levels (0.20).
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              Is Open Access

              Populations at risk for severe or complicated influenza illness: systematic review and meta-analysis

              Dominik Mertz, Tae Kim, Jennie Johnstone … (2013)
              Objective To evaluate risk factors for severe outcomes in patients with seasonal and pandemic influenza. Design Systematic review. Study selection Observational studies reporting on risk factor-outcome combinations of interest in participants with influenza. Outcomes included death, ventilator support, admission to hospital, admission to an intensive care unit, pneumonia, and composite outcomes. Data sources Medline, Embase, CINAHL, Global Health, and the Cochrane Central Register of Controlled Trials to March 2011. Risk of bias assessment Newcastle-Ottawa scale to assess the risk of bias. GRADE framework to evaluate the quality of evidence. Results 63 537 articles were identified of which 234 with a total of 610 782 participants met the inclusion criteria. The evidence supporting risk factors for severe outcomes of influenza ranged from being limited to absent. This was particularly relevant for the relative lack of data for non-2009 H1N1 pandemics and for seasonal influenza studies. Limitations in the published literature included lack of power and lack of adjustment for confounders was widespread: adjusted risk estimates were provided for only 5% of risk factor-outcome comparisons in 39 of 260 (15%) studies. The level of evidence was low for “any risk factor” (odds ratio for mortality 2.77, 95% confidence interval 1.90 to 4.05 for pandemic influenza and 2.04, 1.74 to 2.39 for seasonal influenza), obesity (2.74, 1.56 to 4.80 and 30.1, 1.74 to 2.39), cardiovascular diseases (2.92, 1.76 to 4.86 and 1.97, 1.06 to 3.67), and neuromuscular disease (2.68, 1.91 to 3.75 and 3.21, 1.84 to 5.58). The level of evidence was very low for all other risk factors. Some well accepted risk factors such as pregnancy and belonging to an ethnic minority group could not be identified as risk factors. In contrast, women who were less than four weeks post partum had a significantly increased risk of death from pandemic influenza (4.43, 1.24 to 15.81). Conclusion The level of evidence to support risk factors for influenza related complications is low and some well accepted risk factors, including pregnancy and ethnicity, could not be confirmed as risks. Rigorous and adequately powered studies are needed.
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                Author and article information

                Journal
                Title: JAMA Pediatrics
                Abbreviated Title: JAMA Pediatr
                Publisher: American Medical Association (AMA)
                ISSN (Print): 2168-6203
                Publication date (Electronic): December 18 2023
                Affiliations
                [1 ]Department of Pediatrics, Baylor College of Medicine and Texas Children’s Hospital, Houston
                [2 ]Influenza Division, National Center for Immunization and Respiratory Disease, US Centers for Disease Control and Prevention, Atlanta, Georgia
                [3 ]Vanderbilt University Medical Center, Nashville, Tennessee
                [4 ]University of Pittsburg Medical Center Children’s Hospital of Pittsburgh, University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania
                [5 ]Seattle Children’s Research Institute, Seattle, Washington
                [6 ]Cincinnati Children’s Hospital Medical Center, University of Cincinnati College of Medicine, Cincinnati, Ohio
                [7 ]University of Missouri, Kansas City School of Medicine, Children’s Mercy Kansas City, Kansas City
                [8 ]University of Rochester School of Medicine and Dentistry, Rochester, New York
                [9 ]University of California Los Angeles Mattel Children’s Hospital, Los Angeles
                [10 ]for the New Vaccine Surveillance Network Collaborators
                Article
                DOI: 10.1001/jamapediatrics.2023.5639
                PubMed ID: 38109102
                SO-VID: cab45b4c-740e-46ef-8502-95af254ce427
                Copyright © © 2023
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