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澳洲产的流感疫苗Fluvax被发现有比正常值高9倍的可能引发新生儿惊厥。
疫苗将继续使用但是取决于一定的预防措施。
Fluvax由疫苗公司CSL出品,已被证明是发生在西澳州的59起病例和其他州20起病例的起因。大部分的为两岁以下婴儿,他们已全部康复。
尽管专家们在上个月进行了调查,但是仍然无法给出合理的解释。
该疫苗的不良反应率为千分之九,高于预期的千分之一以下。
联邦首席卫生官Jim Bishop昨天说停止对5岁以下儿童接种季节性流感疫苗的禁令仍将继续。
CSL也被要求在随疫苗发放给病人的说明书中声明有较高的惊厥危险。
http://www.smh.com.au/lifestyle/ ... -20100601-wvfh.html
Ban extended on flu vaccine for children
June 2, 2010
THE Australian-made flu vaccine Fluvax, found to trigger a nine times higher than the expected rate of convulsions in babies, will remain available for use but subject to precautionary measures.
Fluvax, a product of the vaccine company CSL, has been identified as being the most likely trigger of 59 convulsions in Western Australia and in about 20 cases elsewhere, including four in NSW and six in Victoria. All the babies, most of them under two years, recovered fully.
Despite investigations in the past month, experts have not identified a biological explanation for the higher rate of convulsions. These occurred in nine out of every 1000 children vaccinated, when the expected rate was fewer than one in 1000.
The Commonwealth's chief medical officer, Jim Bishop, said yesterday the suspension of seasonal flu vaccinations for healthy children aged under five would continue.
CSL is also being required to declare the increased convulsion risk in patient information leaflets distributed with Fluvax.
Professor Bishop said that where infants were at risk of respiratory diseases such as asthma, and an influenza shot was advisable, parents should discuss with their doctor whether a seasonal flu vaccination would be the best option.
He urged caution in the use of Fluvax for the under-fives and said the other two seasonal flu vaccines available, Influvac and Vaxigrip, were not yet completely in the clear because of lower use in Australia.
An alternative for both healthy children and those at risk of other diseases was the swine flu vaccine, Panvax, which has been shown to be safe, he said.
Fluvax contains elements designed to protect against two strains of seasonal flu and also against swine flu. The reason why this combination triggers convulsions is not yet known. |
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