Afluria is a flu vaccine vaccine made by Merck & Co., Inc. A recent FDA alert stated that the vaccine is associated with an increased risk of fever and febrile seizures in young children.
The reports that lead to this alert came from Australia and noted that the drug caused seizures mainly in children under five years of age. Afluria has been approved for use in the United States. The available data suggested that increased rates in fever and febrile seizures in young children were only associated with the vaccine formula used n the Southern Hemisphere. There are, however, other influenza vaccines used in the Southern Hemisphere that have not presented any such adverse events. The FDA is requiring that further studies be conducted to determine how the Afluria vaccine may affect children regarding the fever and febrile seizure events seen in those living in the Southern Hemisphere.
As a result, the United States will not receive the 0.25 milliliter single-dose pre-filled syringes that are used for young children. The 0.5 milliliter single-dose pre-filled syringes and five milliliter multi-dose vials will, however be distributed.
The importance of influenza vaccines has risen over the past several years due to an increase in the different types of the disease that plagues millions of patients each year. The side effects that can be associated with Afluria and other vaccines could be very harmful and should be treated accordingly. Adverse events like those noted in Australia are being treated, so they do not continue to occur as a result of Afluria being administered to small children.
The FDA has updated the warnings on the precaution sections of the prescribing information for Afluria. This information will be noted by healthcare professionals who will follow any further studies on this matter. The FDA will continue to provide updates as any new information becomes available.
This is especially important since many of the influenza vaccines are being distributed earlier this year to ward off various strains of the virus and decrease the number affected by its symptoms. Before your children are vaccinated, it is advisable to talk with your healthcare professional about any known risks that may be associated with the medication being used. This may be especially important if one or more of your children is younger than five years.