ACIP Recommends Against Use of Afluria in Children Ages 6 Months Through 8 Years

Vaccine Linked to Higher Fever Incidence, Febrile Seizure Risk

August 12, 2010 05:45 pm News Staff

The CDC's Advisory Committee on Immunization Practices, or ACIP, has recommended(www.cdc.gov) that Afluria, the trivalent inactivated seasonal flu vaccine manufactured by the Australian company CSL Ltd. and distributed in the United States by Merck and Co. Inc., not be given routinely to children younger than 9 years old.

The ACIP, which made the recommendation during its Aug. 5 meeting, based its decision on data that indicate an increased risk of febrile seizures in children ages 6 months through 4 years following vaccination with CSL's Fluvax and Fluvax Junior. The committee also looked at data that showed a higher incidence of reported fever in children ages 5 years through 8 years following Fluvax vaccination this year compared with the incidence seen after Fluvax vaccination during previous seasons and after immunization with other flu vaccines on the market this year.

A higher incidence of fever in children ages 5 years through 8 years also was reported during a 2009 U.S. trial of Afluria, which is antigenically similar to Fluvax and Fluvax Junior.

Use of Fluvax and Fluvax Junior was suspended in both Australia and New Zealand earlier this year.

The ACIP recommended that other age-appropriate, licensed seasonal influenza vaccine formulations be used to prevent influenza in children ages 6 months through 8 years.

If no other age-appropriate, licensed flu vaccine is available for a child age 5 years through 8 years who has a medical condition that increases his or her risk for influenza complications, the committee said Afluria may be given. However, physicians should discuss the benefits and risks of vaccination with the child's parents or caregivers before administering Afluria.

Four other seasonal vaccines are licensed for use in children in the United States:

  • Sanofi Pasteur's trivalent inactivated vaccine, which is marketed as Fluzone, may be used in children ages 6 months and older;
  • MedImmune's live, attenuated influenza vaccine, which is marketed as FluMist, may be used in children ages 2 years and older;
  • GlaxoSmithKline's trivalent inactivated vaccine, which is marketed as Fluarix, may be used in children ages 3 years and older; and
  • Novartis' trivalent inactivated vaccine, which is marketed as Fluvirin, may be used in children ages 4 years and older.

The FDA approved Afluria for use in adults ages 18 and older in 2007, and the vaccine was approved for use in children as young as age 6 months in 2009. Alfluria still is recommended for use in individuals ages 9 years and older.

Beginning in mid- to late August, Merck expects to ship 7 million doses of the vaccine in prefilled syringes this season, said a company representative.


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