Update: Recommendations of the Advisory Committee on Immunization Practices (ACIP) Regarding Use of CSL Seasonal Influenza Vaccine (Afluria) in the United States During 2010-11

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Update: Recommendations of the Advisory Committee on Immunization Practices (ACIP) Regarding Use of CSL Seasonal Influenza Vaccine (Afluria) in the United States During 2010-11 Powered By Docstoc
					                                 MMWR Morbidity and Mortality Weekly Report



      Update: Recommendations of the Advisory Committee on
    Immunization Practices (ACIP) Regarding Use of CSL Seasonal
   Influenza Vaccine (Afluria) in the United States During 2010–11

    During the 2010 influenza season in Australia,         Zealand are the only Southern Hemisphere countries
administration of a 2010 Southern Hemisphere sea-          in which Fluvax Junior and Fluvax have been used
sonal influenza trivalent inactivated vaccine (TIV)        during 2010. Investigations in Australia indicated that
(Fluvax Junior and Fluvax) manufactured by CSL             administration of 2010 Fluvax or Fluvax Junior was
Biotherapies was associated with increased frequency       associated with higher rates of fever in young children
of fever and febrile seizures in children aged 6 months    4–24 hours after vaccination when compared with
through 4 years (1). Postmarketing surveillance indi-      rates observed with TIV during previous years (1).
cated increased reports of fever in children aged 5–8      A retrospective cohort study among children aged
years after vaccination with Fluvax compared to pre-       <5 years who received TIV in 2010 reported that the
vious seasons. An antigenically equivalent 2010–11         risk for fever following receipt of Fluvax was 6.5 times
Northern Hemisphere seasonal influenza TIV (Afluria)       greater than for Influvac (Solvay/Abbott), a different
manufactured by CSL Biotherapies is approved by the        TIV (1). Other data indicated that the rate of fever
Food and Drug Administration (FDA) for persons             in 2010 was eight times greater after receipt of Fluvax
aged ≥6 months in the United States. Prescribing           Junior versus Influvac among children aged <3 years,
information for the 2010–11 Afluria formulation            and 10 times greater for Fluvax versus Influvac among
includes a warning that “Administration of CSL’s           children aged 3–4 years (1). A follow-up New Zealand
Southern Hemisphere influenza vaccine has been             study among more than 300 children aged <5 years
associated with increased postmarketing reports of         found substantially increased febrile reactions in the
fever and febrile seizures in children predominantly       24 hours after receipt of Fluvax, but not with Vaxigrip
below the age of 5 years as compared to previous years”    (sanofi pasteur), another TIV (6). Postmarketing sur-
(2). In the United States, annual influenza vaccina-       veillance found increased reports of fever in children
tion is recommended for all persons aged ≥6 months.        aged 5–8 years after receipt of 2010 Fluvax compared
On August 5, 2010, the Advisory Committee on               with reports for the same product in three previous
Immunization Practices (ACIP) recommended that             seasons (unpublished data, CSL; 2010). An increased
the 2010–11 Afluria vaccine not be administered to         frequency of fever after receipt of 2009 CSL seasonal
children aged 6 months through 8 years. Other age-         TIV compared with TIV from another manufacturer
appropriate, licensed seasonal influenza vaccine for-      among children aged 6 months through 8 years age
mulations should be used for prevention of influenza       also was reported in a U.S. clinical trial (2).
in these children. If no other age-appropriate, licensed       Additional investigations determined that the
inactivated seasonal influenza vaccine is available for    higher frequencies of fever with Fluvax and Fluvax
a child aged 5–8 years who has a medical condition         Junior in Australia during 2010 were associated with
that increases their risk for influenza complications      substantially higher rates of febrile seizures in chil-
(3), Afluria can be used; however, providers should        dren aged 6 months through 4 years; febrile seizures
discuss with the parents or caregivers the benefits and    occurred a mean of 7.2 hours (range: 5.9–8.4 hours)
risks of Afluria use before administering this vaccine     after vaccination (1). Overall, the rate of febrile
to children aged 5–8 years.                                seizures following Fluvax and Fluvax Junior was
                                                           estimated at ≤9 per 1,000 doses administered, and
Background                                                 approximately nine times more
				
DOCUMENT INFO
Description: Details on the recommendations of the Advisory Committee on Immunization Practices (ACIP) regarding the use of CSL Biotherapies' seasonal influenza vaccine (Afluria) in the US during 2010-2011 are presented. One of ACIP's recommendations is that the 2010-2011 Afluria vaccine should not be administered to children aged six months through eight years.
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