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Australia - CSL Recalls Flu Shot as Side Effects Rise Nine-Fold - Ban Continues on Shot Due to Convulsions

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  • Australia - CSL Recalls Flu Shot as Side Effects Rise Nine-Fold - Ban Continues on Shot Due to Convulsions

    CSL Recalls Flu Shot as Side Effects Rise Nine-Fold (Update1)
    June 01, 2010, 6:22 AM EDT


    By Simeon Bennett

    June 1 (Bloomberg) -- CSL Ltd., the Southern Hemisphere?s only flu vaccine maker, recalled its seasonal shot for children in Australia after investigations failed to explain a nine-fold increase in fever and convulsions.

    CSL is voluntarily withdrawing unused doses of its Fluvax Junior shot from clinics and distributors, the Melbourne-based company said in a statement today. Jim Bishop, Australia?s chief medical officer, said vaccinations should continue to be suspended for children under 5 years, a recommendation initially made on April 23.

    Fluvax was linked to febrile convulsions in about 9 children in every 1,000 who got the shot, higher than the expected rate of 1 per 1,000, Bishop said in a separate statement. It?s unclear whether Sanofi-Aventis SA?s Vaxigrip and Solvay SA?s Influvac caused similar side effects because insufficient doses have been used in Australia, he said.

    The investigation ?identified no apparent clinical, biological or epidemiological factors that would explain the higher-than-expected observed rates of fever with convulsions,? Bishop said. Laboratory tests and an inspection of CSL?s factory ?revealed no abnormalities to explain this event,? he said.

    Fluvax is the first seasonal influenza vaccine to contain the H1N1 strain of swine flu. Panvax, a separate shot for swine flu, has been shown to be safe and effective in young children, Bishop said.

    Retrieval Program

    CSL called the product withdrawal a ?retrieval? and said it?s occurring outside the regulatory process.

    The company said it isn?t able to provide a figure for the withdrawal because it doesn?t know how many doses have been used. The pediatric vaccine hasn?t been distributed outside Australia this year, CSL said in an e-mail.

    The recall ?is unlikely to be material? to CSL?s earnings because only a small volume of the vaccine probably remains on the market, UBS AG said in a note.

    At least 55 children younger than 5 years in Western Australia have been identified with possible convulsions after receiving the shot and a further 196 had less serious reactions such as fever, vomiting and inflammation at the injection site, the state health department said in April. As many as 30,000 children in the age group have been vaccinated so far this year, the department estimated.

    More children have been vaccinated in Western Australia than elsewhere in the country because they receive free shots under a program in the state. The plan cut hospitalizations by 88 percent in 2008, the state?s health department said last year.

    --Editors: Lena Lee, Phil Serafino.

    Twitter: @RonanKelly13
    The views expressed are mine alone and do not represent the views of my employer or any other person or organization.

  • #2
    Re: CSL Recalls Flu Shot as Side Effects Rise Nine-Fold

    via email -


    Convulsions Linked to Flu Shot Persuade Australia to Keep Ban
    2010-06-01 07:33:05.748 GMT


    By Jason Gale
    June 1 (Bloomberg) -- An unexplained increased in the rate
    of fever and convulsions in infants after vaccination against
    seasonal flu has persuaded Australia?s top doctor to maintain a
    suspension on the shots for children under 5 years of age.
    The reactions have been associated mainly with CSL Ltd.?s
    Fluvax immunization, Jim Bishop, Australia?s chief medical
    officer, said in a statement today.</pre>

    Comment


    • #3
      Re: Australia - CSL Recalls Flu Shot as Side Effects Rise Nine-Fold - Ban Continues on Shot Due to Convulsions





      Australian flu-vaccine probe confirms increased reactions in small children



      from Lisa Schnirring

      Jun 1, 2010 (CIDRAP News) ? Australia's chief medical officer today renewed his advice for clinicians to suspend seasonal flu vaccination for healthy children younger than 5 after national investigations confirmed higher-than-expected rates of fever and convulsions after immunization in that age-group.
      In a statement today, Dr Jim Bishop said the reactions in younger children have been linked mainly to Fluvax, made by Australian producer CSL Ltd. Investigations by the country's drug regulator, its vaccine advisory group, and the National Center for Immunization Research and Surveillance found no clinical, biological, or epidemiologic factors that would explain the higher rates of fever with convulsion. The groups put the rate at 9 per 1,000 children vaccinated, versus an expected rate of less than 1 in 1,000.



      snip

      Comment


      • #4
        Re: Australia - CSL Recalls Flu Shot as Side Effects Rise Nine-Fold - Ban Continues on Shot Due to Convulsions

        Panvax febrile reactions not a predictor

        Published 21 July 2010, doi:10.1136/bmj.c3714
        Cite this as: BMJ 2010;341:c3714
        Letters
        Child influenza vaccination
        Panvax febrile reactions not a predictor
        The first 150 words of the full text of this article appear below.

        Collignon and colleagues assert that febrile reactions seen in pandemic influenza A/H1N1 vaccine (Panvax) clinical trials were an overlooked predictor of the excess febrile reactions seen with CSL’s seasonal trivalent influenza vaccine that prompted suspension of its use in children under 5.1 Yet most febrile reactions reported in the Australian Panvax trial were mild, with severe fever (>39.5&#176;C) in only 2&#37;.2 Fever was dose related, and the results included children who received 30 &#181;g—four times the dose in Fluvax Junior. In the 15 &#181;g arm, only one child had severe fever after the first dose. In the US trial,3 which evaluated 7.5 &#181;g and 15 &#181;g doses, rates of moderate and severe fever in under 3s in the 7.5 &#181;g arm were both less than 2%. In children 3 years and older, rates of fever in the 7.5 &#181;g group were similar to those for placebo. Severe fever did not . . . [Full text of this article]

        Ruth Lopert, principal medical adviser1, Terry Nolan, head2

        1 Therapeutic Goods Administration, Symonston, ACT 2609, Australia, 2 Melbourne School of Population Health, University of Melbourne and Murdoch Children’s Research Institute, Parkville, VIC 3010, Australia

        ruth.lopert@tga.gov.au



        Collignon and colleagues assert that febrile reactions seen in pandemic influenza A/H1N1 vaccine (Panvax) clinical trials were an overlooked predictor of the excess febrile reactions seen with CSL’s seasonal trivalent influenza vaccine that prompted suspension of its use in children under 5.1 Yet most febrile reactions reported in the Australian Panvax trial were mild, with severe fever (>39.5°C) in only 2%.2 Fever …

        Comment


        • #5
          Re: Australia - CSL Recalls Flu Shot as Side Effects Rise Nine-Fold - Ban Continues on Shot Due to Convulsions

          Commentary: it is unclear why this increased rate of adverse reactions is occurring. Monovalent shots produced by the same manufacturer have not produced similar levels of adverse events, and tests for contamination have not yeilded results or provided an explanation.

          As such there are many unanswered questions. A possible explanation may lie in the trivalent nature of the vaccine, as the other components are traditional seasonal flu strains.

          More testing is needed to determine answers before the onset of the northern hemisphere vaccination season to find out if the problem is unique to CSL product or common to all child influenza vaccinations where pandemic H1N1 is mixed with 2 other traditional flu strains. If the latter is true it may be necessary for children to continue to receive monovalent flu shots for pandemic H1N1 in the northern hemisphere this winter.

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