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Study Shows Inhaled Flu Vaccine Safe


3 Star

Study Shows Inhaled Flu Vaccine Safe

Our Review Summary

The story is about safety of inhaled flu vaccine based on adverse events voluntarily reported since it became available two years ago. This report could have better clarified that inhaled flu vaccine is targeted to populations that are not included in the CDC recommendations for getting flu shots. However, many individuals who do not meet CDC criteria get the flu shot because it is offered by their employer or they get it from a health care provider or other commercial source. The question is whether this article helps people to know whether they should prefer a flu shot or FluMist. Some ideas that were developed minimally or not at all in the story include the fact that more is known (benefits and risks) about flu shots than FluMist because shots have been around and used for years, and the uncertainty about potential harms of FluMist (because it uses live not killed virus). The story incorrectly implies that the adverse event rate is 460 out of 2.5 million doses, but it doesn’t mention that it’s hard to know whether there are many more adverse events (minor or major) that were simply not reported. Readers are left wondering how the authors arrived at the conclusion that the vaccine is safe.


Does the story adequately discuss the costs of the intervention?

Not Satisfactory

No mention of costs or


Does the story adequately quantify the benefits of the treatment/test/product/procedure?

Not Satisfactory

Only the

last sentence of the article addresses possible benefits of the inhaled vaccine, stating that it is likely to be as effective

as the flu shot, but provides no evidence to confirm or support that.

Does the story adequately explain/quantify the harms of the intervention?

Not Satisfactory

Absolute numbers of reported adverse events are provided (total

number of events, number of serious events, and some specific examples, such as number of asthma events). However, key

points we don’t know are how many serious adverse events weren’t reported (reporting is voluntary) and how do these numbers

compare to adverse events with flu shots given in a similar population. While the former is not known, the latter could have

been found and reported and would have been more useful than the info provided.

Does the story seem to grasp the quality of the evidence?

Not Satisfactory

The story reports number of adverse

events reported voluntarily with inhaled flu vaccine, leading government officials to claim it is safe. But the story did not

clarify how these data were evaluated and how these data translate to safety. Although intuitively the numbers might seem

low, what is safe and how is that defined? Since the flu shot is the standard of care, the true question is whether the

inhaled vaccine is safer and more effective than the flu shot, which would require a real study.

Does the story use independent sources and identify conflicts of interest?


Independent corroboration is obtained by getting input from a physician not associated with the government


Does the story compare the new approach with existing alternatives?

Not Satisfactory

The story doesn’t let readers know that most doctors think the standard flu shot is the preferred treatment and

the main reason one would consider inhaled vaccine is if flu shots were not available.

Does the story establish the availability of the treatment/test/product/procedure?


Story accurately describes vaccine has been available in the U.S. for 2 years. However, the story

could have mentioned how many doses are available for the current year, since flu vaccine availability can change from


Does the story establish the true novelty of the approach?


Story states inhaled vaccine

has been used for 2 years.

Total Score: 4 of 9 Satisfactory


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