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FDA Cites Safety Concerns with Nasal Flu Spray

© Maggie Herman

An advisory panel to the Food and Drug Administration (FDA) has decided that the nasal flu spray FluMist may present a risk of harm to children and others, even though the vaccine may in fact be effective.

FluMist is an alternative to the traditional flu vaccine, in that it can be inhaled without the pain of a shot. It also differs from the shot in one other significant way-while the shot contains a dead version of the virus, the nasal spray is made from a weakened flu virus. However, it is this very difference that caused the panel concern. According to the panel, use of the live virus presents too many concerns and requires further investigation.

The panel found that the spray is effective for both adults and children, although the vote on pediatric and adolescent efficacy was a close one (8-7). The spray is designed to stimulate the immune system through nasal tissue-the tissue where the flu virus attacks. Data was presented to the panel indicating that FluMist is 93 percent effective in preventing influenza in children, but the committee noted that the spray has proven ineffective in reducing fever during a flu outbreak. Specifically, recipients were just as likely as the nonvaccinated to experience flu-like illness during the height of the season.

More than the data that was presented, though, the panel expressed concern about what was not presented. Specifically, the committee noted that no data was provided on how the spray would interact with other childhood vaccinations. Additionally, the group expressed concern about risk of pneumonia or asthma in some children. The panel noted that in a study of 1,600 children vaccinated with either the nasal spray or placebo, 37 children receiving the vaccine developed pneumonia, while only 12 cases of pneumonia were identified in the placebo group. Moreover, no data was presented on the efficacy of the vaccine for children under 15 months of age. Finally, the manufacturer has not studied the impacts of repeated annual doses.

No one who has asthma should receive the nasal vaccine, as it is thought to trigger asthma reactions.

The panel did not vote on whether it would recommend the vaccine to the FDA. Instead, the panel cited the need for additional information in order to make such a determination.

In addition to concerns related to pediatric use, the panel also identified other potential at-risk groups, including the elderly and people with asthma or other illnesses. These groups are most at risk for suffering complications from the flu. Studies are underway for those groups.

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