The European Medicines Agency warns that young children given GlaxoSmithKline's swine flu shot may get a fever after their second dose.

    In a statement issued Friday, the European drug regulator said data from GlaxoSmithKline PLC showed a higher number of children aged six months to 3 years had a fever after their second dose of the Pandemrix vaccine, compared with the first. Kids were also more likely to have side effects like muscle pain, drowsiness, and irritability.

    The European regulator recommends children get two doses of swine flu vaccine, though Glaxo says one dose is enough.

    Glaxo's vaccine contains an adjuvant, a chemical compound to boost the immune response. It is sold across Europe and Canada.

    Another formulation of Glaxo's vaccine, without the adjuvant, is available in the U.S. Vaccines with adjuvants usually cause more side effects. No flu vaccines with adjuvants are licensed in the U.S.

    Last month, Glaxo advised health authorities not to use one batch of its Canadian-manufactured swine flu vaccine in case it triggered life-threatening side effects like anaphylactic shock.

    In a press briefing on Thursday, the World Health Organization's flu chief Keiji Fukuda said that more than 150 million doses of swine flu vaccine have been distributed in more than 40 countries and that they had not seen any evidence to suggest the vaccines caused worrying side effects.

    歐洲藥品管理局發(fā)出警告說，注射過葛蘭素史克公司的豬流感疫苗的幼兒，二次注射之后可能會發(fā)熱。

    在星期五發(fā)布的一項聲明中，歐洲醫(yī)藥管理部門說，來自葛蘭素史克公司的數(shù)據(jù)表明，與第一次注射相比，數(shù)量較多的年齡在6個月到3歲的兒童第二次注射 Pandemnrix 疫苗之后，已出現(xiàn)發(fā)熱現(xiàn)象。很可能出現(xiàn)副作用，如肌肉酸痛、困倦和過敏。

    盡管葛蘭素史克公司稱注射一次豬流感疫苗就足夠了，但歐洲藥品管理部門仍建議兒童注射兩次。

    葛蘭素史克公司的疫苗含有一種促進免疫反應(yīng)的輔藥和化學物質(zhì)。這種疫苗在全歐洲和加拿大銷售。

    葛蘭素史克公司另一種配方的疫苗不含輔助藥料，在美國可以買到。含有輔助藥料的疫苗通常引起更多的副作用。這種疫苗在美國沒有獲得許可。

    上個月，葛蘭史克公司建議衛(wèi)生機構(gòu)，如果加拿大生產(chǎn)的一批疫引發(fā)威脅生命的象過敏性休克這樣的副作用，則不要使用。

    在星期二的新聞發(fā)布會上，世界衛(wèi)生組織流感部干事福田敬二說，1.5億支流感疫苗已發(fā)放到40多個國家，還說，他們并沒有發(fā)現(xiàn)任何表示疫苗引起的讓人擔憂的副作用的證據(jù)。