The design of randomised controlled trials also allows for more control over variables that can affect how well a vaccine works under ideal conditions.
Participants are checked each week to see if they have any symptoms of an influenza-like illness. If they do, they're tested. This allows researchers to know with more certainty that they have tested everyone with symptoms in their study.
After a time, researchers determine the frequency of influenza in both groups and determine how well the vaccine works. This is called vaccine efficacy.
The most commonly used observational study is known as a case-control study. This helps estimate how well influenza vaccines work in a real-world setting, where people unwell enough to seek out care and those with risk factors for complications become the primary study population. This tends to reduce the impact of the vaccine when compared to RCTs but reflects how influenza vaccines are used.
With this study type, people seeking care for an acute respiratory illness (known as an influenza-like illness) at a doctor's surgery or medical clinic are voluntarily enrolled in the study. They're identified as a case if they test positive for the influenza virus and are designated a control if they test negative.
Researchers compare the frequency of recent influenza vaccination among the cases and the controls, taking into account the same factors considered with the RCT. This estimate of how well the vaccine protects is known as vaccine effectiveness.
During the 2008 and 2009 influenza seasons, an RCT was conducted in Australia and New Zealand in healthy, non-elderly adults. Vaccine efficacy against all three influenza strains included in the vaccine was 60 per cent.
Case-control studies in Australia found similar results.
While estimates of how well the vaccine works each year vary (because the vaccine formula changes), the average effectiveness from 2007 to 2011 was 62 per cent in healthy adults under 65.
How well the vaccine works in a given year also depends on the dominant strain of the virus in circulation and the population group that's most affected.
All this means that, on average, healthy, non-elderly adults in Australia can expect the vaccine to prevent an influenza infection serious enough to require medical care about 60 per cent of the time. Based on data from clinical trials, up to 10 per cent of adults and up to 20 per cent of young children will be diagnosed with seasonal influenza in a given year.
In children aged from six to 59 months, results from an observational study showed the vaccine works about 70 per cent of the time in preventing influenza that requires medical attention.
The results of these Australian studies are similar to a recently conducted review of influenza vaccine efficacy and effectiveness from multiple countries.
But data is limited on how well influenza vaccines work in adults over 65 and in people with chronic health conditions and other risk factors that increase the likelihood of complications.
Yet these are the populations for which the influenza vaccine is strongly recommended.
What the data shows is that the influenza vaccine doesn't work as well in these populations as it does in healthy adults of working age. During the past influenza season, vaccine effectiveness in people over 65 in the United States was 27 per cent, while overall effectiveness for all ages was 56 per cent.
While influenza vaccines don't provide the level of protection desired by public health, they are still the best way to prevent influenza for most people. They should continue to be used while better vaccines are developed.
Nick Kelley is research associate at the Centre for Infectious Disease Research and Policy at the University of Minnesota.
theconversation.edu.au
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