October 29, 2004

Study tests use of flu spray to treat children

Featured Image

Diane Kent, R.N., administers the FluMist nasal vaccine to Abigail Moore, 19 months, as her mother Julie and brother Jack, 2, look on. Jack was also part of the study, which compared FluMist to the regular flu shot.
photo by Dana Johnson

Study tests use of flu spray to treat children

Two-year-old Ellie Seehorn seemed unimpressed with the crowd of people she encountered at her pediatrician's office last Thursday. A number of research experts from the Monroe Carell Jr. Children's Hospital at Vanderbilt visited her that day, as well as a few people with notepads and cameras documenting the day for the local media. Ellie was the first patient to take part in the FluMist study headed by Kathryn Edwards, M.D., professor of Pediatrics, and her researcher team at the offices of Pediatric Associates of Franklin.

The study is an important one for children who hate to get shots, but this year, the shortage of flu vaccine has made studies like this one a topic of public interest.

The difficulties researchers had to traverse, thrown up by a nationwide shortage of vaccine, brings into question the current system of manufacturing and distributing vaccines. The shortage is so severe this year that this particular study was seriously impacted.

The study was originally designed to test the safety and effectiveness of the FluMist nasal spray vaccine in children between 6 months and 5 years of age. But due to the shortages, the study has been changed to only include children between the ages of 6 months and just under 3 years. A total of 110 children in this age group will be given the flu vaccine in one of two forms: either a regular flu shot, or the FluMist nasal spray vaccine manufactured by MedImmune.

The study was changed because the supplier of the flu shots had to divert doses used in the older children to high risk adults. Flu shots for children under 3 years of age are actually given in a half-size dose, and were more available. The study had both fewer participants and a narrower age range than originally planned. As a result, FluMist won't be tested in children between the ages of 3 and 5 years this year.

“Whether this change in the age group will affect licensing FluMist through the FDA, I don't know,” said Edwards. “But nobody is winning in this shortage.”

Over the course of the last week, the children, all regular patients of Pediatric Associates in Franklin, got both a nasal spray and a shot, but one or the other was a placebo.

The research team is seeking to answer the question of whether the nasal spray vaccine is both safe and effective for healthy children under age 3; an age group that already receives about two dozen shots for immunization. The American Academy of Pediatrics recently recommended that all children 6 months to 2 years old get the flu vaccine. The recommendation is based on research that shows children under 2 are often hospitalized with side effects of the flu.

“Right now we have one bullet in our holster,” said Edwards. “The flu shot vaccine is the only approved vaccine for children in this age group and as we see with shortages that we often have, that is not enough. Right now FluMist is not approved for any children under the age of 5. If we can prove that it is safe and as effective as the shot, we could have another vaccine to use.”

Edwards said having a choice between the shot and the nasal spray widens the options in a shortage year so more children could get vaccinated.

The families who took part in the FluMist study seemed quite happy to be avoiding long lines and the potential of the supplies of vaccine running out before their child received it. They happily sat through a physical exam for their child, a series of questions before the vaccine was given, then a 15 minute wait to be sure no child reacted poorly to the vaccine.

On top of a total of about an hour spent in the Pediatric Associates' clinic, each family took home a notebook, a thermometer, and a series of symptoms to look for in their child over the winter.

“I was just glad she got vaccinated,” said Ellie's mother, Margaret Seehorn. By the end of the day, Ellie had drawn a picture for the staff, and it hung on the door.

“This is testimony to our valuable relationship with this pediatric practice,” said Edwards. “This practice has been very helpful, providing us space, encouraging their own patients to enroll. Without them this study would not be possible.”

The parents said the most exciting part of all this would be seeing if the nasal spray gets fully approved for next season. If that happens, parents of children under 5 years of age would have the choice to get the vaccine without the needle, for a bit more cash.

“These families are helping us to get another bullet in our holster for the future, which is especially helpful during years when there are shortages,” said Edwards.