bioCSL Fluvax® vaccine has been one of the Australian prescriber’s favourite seasonal influenza vaccines to prevent the dreaded symptoms of ‘flu’ amongst the general population. However, in 2010 there was a significantly increased number of febrile reactions and convulsions in children under five years of age following immunisation with Fluvax® than occurred with other vaccine brands. Subsequently, a black box warning was added to the Fluvax® product information contraindicating its use in this patient group. Warnings were also added to Fluvax® packaging and refrigerator stickers introduced (Figure. 1) as a reminder to healthcare professionals.

Figure 1. Fluvax® warning stickers 2015

Fluvax Caution StickerFluvax Warning Label

 

At the time of these events, bioCSL liaised with Australian government departments and a number of safety alert notices were issued along with direct communication with general practitioners identified as having administered Fluvax® to children under the age of five during that year.

Investigations have found that the febrile reactions may have been caused by the combined effect of new viral strains introduced into the 2010 vaccine which triggered stronger immune reactions, as well as responses to additional viral components released during the manufacturing process from these strains.

For patients under five years old, prescribers have the opportunity to select from a number of alternative trivalent inactivated influenza vaccines available, such as Agrippal®, Fluarix®, Influvac®, and Vaxigrip®, that are less likely to induce fever and are recommended for use in young children.

Although declining from 115 in 2012, the use of Fluvax® in children under five years of age in Australia is known to have continued into the 2014 influenza season, when 34 doses were administered. Although no reports of adverse events were submitted, with the contraindication in place, and alternatives available, healthcare professionals should have no reason to administer Fluvax® to this patient group.

With the vaccine for the 2015 season having also undergone extensive reformulation, we healthcare professionals should seek to prevent these types of unfortunate incidents occurring. One simple step may be to avoid using Fluvax as a generic term, and instead refer to influenza vaccine so as to minimise potential for confusion.

References:

  1. Therapeutic Goods Administration. bioCSL Fluvax – not for children under 5 years. Medicines Safety Update 2014;5(1):22.
  2. Australian Government Department of Health. Immunise Australia Program. Canberra, Australia.
  3. Fluvax given to dozens of young children despite ban. ABC News 2014; February 4.

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