In the JournalsPerspective

LAIV ineffective for children during 2015-2016 season

Although vaccination against influenza lessened the chances of illness, the live-attenuated vaccine demonstrated inefficacy and the inactivated vaccine demonstrated significant effectiveness in children for the 2015-2016 season, according to a study published in The New England Journal of Medicine.

“The effectiveness of influenza vaccination and the corresponding effect of vaccination programs on the burden of influenza can vary considerably from year to year,” Michael L. Jackson, PhD, from the Kaiser Permanente Washington Health Research Institute, and colleagues wrote. “In light of this variability, annual observational studies of influenza vaccine effectiveness are critical as ongoing evaluations of the value of influenza vaccination programs, as well as for identifying problems with licensed influenza vaccines.”

To assess the impact of changing the A(H1N1)pdm09 virus strain in the live-attenuated influenza vaccine (LAIV) and the effectiveness of this strain in 2015-2016, the researchers conducted a study in which children 6 months and older with acute respiratory illness were recruited from ambulatory care clinics throughout the United States. They then projected vaccine effectiveness using a test-negative design, with independent estimates made for inactivated vaccines and the LAIV.

Of the 6,879 children included in the study, 19% had confirmed influenza. The most frequently observed strains were A(H1N1)pdm09, with 11% of participants testing positive, and influenza B, with 7% testing positive. Vaccination was able to provide protection against 48% of all influenza-related illness (95% CI, 47-70; P < .001).

The inactivated vaccine was 60% effective against influenza in children between the ages of 2 and 17 years (95% CI, 47-70; P < .001); however, the LAIV demonstrated inefficacy at 5% (95% CI, 47 to 39; P =  .80). Additionally, protection against A(H1N1)pdm09 was observed at 63% among children who were administered the inactivated vaccine (95% CI, 45-75; P<0.001), whereas the LAIV demonstrated an efficacy of 19% against this strain (95% CI, 113 to 33; P = .55).

“Although these observational studies consistently showed lower effectiveness for the LAIV than for the inactivated vaccines, point estimates for the effectiveness of the LAIV varied widely among studies. The reasons for this are unclear,” Jackson and colleagues wrote. “The quadrivalent LAIV in the U.S., Finland and the United Kingdom were all produced by the same manufacturer at the same plant, so it is unlikely that differences in estimated vaccine effectiveness are due to variations in the vaccine product.” – by Katherine Bortz

Disclosure: Please see the study for a full list of relevant financial disclosures.

Although vaccination against influenza lessened the chances of illness, the live-attenuated vaccine demonstrated inefficacy and the inactivated vaccine demonstrated significant effectiveness in children for the 2015-2016 season, according to a study published in The New England Journal of Medicine.

“The effectiveness of influenza vaccination and the corresponding effect of vaccination programs on the burden of influenza can vary considerably from year to year,” Michael L. Jackson, PhD, from the Kaiser Permanente Washington Health Research Institute, and colleagues wrote. “In light of this variability, annual observational studies of influenza vaccine effectiveness are critical as ongoing evaluations of the value of influenza vaccination programs, as well as for identifying problems with licensed influenza vaccines.”

To assess the impact of changing the A(H1N1)pdm09 virus strain in the live-attenuated influenza vaccine (LAIV) and the effectiveness of this strain in 2015-2016, the researchers conducted a study in which children 6 months and older with acute respiratory illness were recruited from ambulatory care clinics throughout the United States. They then projected vaccine effectiveness using a test-negative design, with independent estimates made for inactivated vaccines and the LAIV.

Of the 6,879 children included in the study, 19% had confirmed influenza. The most frequently observed strains were A(H1N1)pdm09, with 11% of participants testing positive, and influenza B, with 7% testing positive. Vaccination was able to provide protection against 48% of all influenza-related illness (95% CI, 47-70; P < .001).

The inactivated vaccine was 60% effective against influenza in children between the ages of 2 and 17 years (95% CI, 47-70; P < .001); however, the LAIV demonstrated inefficacy at 5% (95% CI, 47 to 39; P =  .80). Additionally, protection against A(H1N1)pdm09 was observed at 63% among children who were administered the inactivated vaccine (95% CI, 45-75; P<0.001), whereas the LAIV demonstrated an efficacy of 19% against this strain (95% CI, 113 to 33; P = .55).

“Although these observational studies consistently showed lower effectiveness for the LAIV than for the inactivated vaccines, point estimates for the effectiveness of the LAIV varied widely among studies. The reasons for this are unclear,” Jackson and colleagues wrote. “The quadrivalent LAIV in the U.S., Finland and the United Kingdom were all produced by the same manufacturer at the same plant, so it is unlikely that differences in estimated vaccine effectiveness are due to variations in the vaccine product.” – by Katherine Bortz

Disclosure: Please see the study for a full list of relevant financial disclosures.

    Perspective

    Ben Fogel
    Ben N. Fogel
    Steven Hicks, MD
    Steven D. Hicks

    The recent study by Jackson and colleagues illustrates the ineffectiveness of the live-attenuated influenza vaccine in the 2015-16 season and supports the AAP’s recommendation to offer only inactivated influenza vaccine (quadrivalent or trivalent) for the 2017-18 season. The study re-affirms that vaccination continues to be the best defense against influenza infection that pediatricians can offer their patients. It effectively reduces influenza risk by 60% among children aged 2 to 17 years. The study also found no significant difference in effectiveness between the quadrivalent and trivalent inactivated vaccines.

    Reassuringly, data from our own study and early data from the CDC show that lack of the live-attenuated vaccine did not impact pediatric influenza vaccination rates in a clinically meaningful way during the 2016-17 influenza season. On an individual basis, however, parents may be wary of influenza vaccine effectiveness. Primary care physicians should reassure families that timely protection with the inactivated vaccine is a safe and effective method of reducing influenza risk.

    Ben N. Fogel, MD, MPH
    Medical director
    Penn State Pediatric Primary Care
    Assistant professor of pediatrics
    Penn State College of Medicine

    Steven D. Hicks, MD, PhD
    Assistant professor of pediatrics
    Penn State College of Medicine

    Disclosures: Fogel and Hicks report no relevant financial disclosures.

    Perspective
    Vytautas Usonis

    Vytautas Usonis

    The safety and effectiveness of influenza vaccines are under rigorous control. This study confirmed that inactivated but not live-attenuated influenza vaccines reduced the risk of influenza illness in the 2015–2016 season. However, it is expected that newly formulated quadrivalent inactivated influenza vaccine will be an effective tool in control of children influenza in the forthcoming season.

    • Vytautas Usonis, MD, PhD
    • Head, Clinic of Children Diseases Faculty of Medicine Vilnius University in Lithuania

    Disclosures: Dr. Usonis reported no relevant financial disclosures.