Flu Vaccine Safe for Babies and Toddlers

Study confirms shot protects against influenza without side effects

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By Serena Gordon
HealthDay Reporter

TUESDAY, Oct. 24, 2006 (HealthDay News) -- Even the youngest children -- those between 6 month and 23 months old -- can safely benefit from the flu vaccine, a new study concludes.

The study, which looked at more than 45,000 infants and toddlers from all over the United States, found there were only a few incidents of side effects that required medical treatment as a result of the vaccine, and none was serious.

"This vaccine is very safe in this age group. For me, as a pediatrician and as a parent, it was very reassuring how few diagnoses there were that were associated with this vaccine," said the study's lead author, Dr. Simon J. Hambidge, an investigator with Kaiser Permanente Colorado's Clinical Research Unit in Denver.

Results of the study appear in the Oct. 25 issue of the Journal of the American Medical Association.

Annually, as many as one in five Americans gets the flu, according to the U.S. Centers for Disease Control and Prevention. More than 200,000 people are hospitalized from flu complications, and as many as 36,000 Americans die from the infection each year, the CDC reports.

The best way to prevent the flu is to get the flu vaccination. The CDC recommends that most people get the shot, but specifically advises the following groups of people to receive the flu vaccine every year:

  • Children between 6 months and 5 years old,
  • Pregnant women,
  • People older than 50,
  • People who live in nursing homes or other long-term care settings,
  • Those with chronic medical conditions, such as diabetes, lung disease and HIV/AIDS,
  • People living with or caring for young children, nursing-home residents or those with compromised immune systems or chronic medical conditions.

The first time an infant or child receives the vaccine, it must be administered in two separate doses, given one month apart. While there are no expected shortages of flu vaccine this year, the vaccine has been slow to arrive at many pediatric offices this fall. According to flu-vaccine maker Sanofi Pasteur, adequate supplies of the vaccine will be available by November or December at the latest.

Children under 2 have an increased risk of serious complications from the flu. The only people at higher risk are those over 65, according to the study.

Beginning with the 2004-05 flu season, the CDC's Advisory Committee on Immunization Practices began recommending that children between 6 months and 23 months of age receive the vaccine. However, the largest study that had been done on this age group included fewer than 9,000 vaccinations.

So, Hambidge, along with colleagues from the Vaccine Safety Datalink Team and eight other health-care organizations, examined retrospective data for more than 45,000 children who got almost 70,000 vaccinations between January 1991 and May 2003.

The researchers looked only for "medically attended" vaccine complications up to 42 days after immunization. Minor side effects such as swelling or tenderness at the injection site weren't included in the analysis.

The only statistically significant association they found was for nausea and vomiting. However, Hambidge said these side effects were probably due to exposure to the influenza virus or another virus around the time of vaccination.

Conditions such as asthma, ear infections and the common cold were actually less likely to occur after vaccination, according to the study. The researchers believe these may also be chance findings.

A previous study had found a possible association between the vaccine and febrile seizures (seizures that occur due to high fevers), but this study found no such link, according to Hambidge.

"This vaccine was already believed to be safe, and this study backs that up," said Dr. David Horwitz, a pediatrician at New York University Medical Center in New York City.

"This study involved a huge number of children. Generally, a study this large would show any kind of significant adverse reaction that might occur," he added.

The bottom line, according to Hambidge, is that this vaccine "will help protect kids against a nasty illness."

More information

To learn more about the flu vaccine, visit the U.S. Centers for Disease Control and Prevention.

SOURCES: Simon J. Hambidge, M.D., Ph.D., pediatrician, Denver Health Community Health Services, and investigator, Kaiser Permanente Colorado's Clinical Research Unit, Denver; David Horwitz, M.D., pediatrician, New York University Medical Center, and clinical associate professor, New York University School of Medicine, New York City; Oct. 25, 2006, Journal of the American Medical Association

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