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【medical-news】默克召回百万儿童疫苗
The drug company Merck told the US Centers for Disease Control and Prevention (CDC) yesterday, Wednesday 12th December, that it is recalling over one million doses of vaccines routinely given to babies and children. The drug company said it was recalling 10 lots of PedvaxHIB vaccine and 2 lots of Comvax vaccine because they could not assure product sterility.
During a routine standard check on manufacturing equipment used in making the two vaccines, the manufacturer said they found signs of a bacteria called Bacillus cereus. However, when samples of the vaccines were tested before shipment, no such contamination was found. The voluntary recall is purely a precaution, said Merck.
Both types of vaccine protect against Hib and other conditions. Hib is short for Haemophilus influenzae type b, a serious disease caused by a bacteria that usually strikes children under 5 years old. Comvax also protects against hepatitis B.
According to the Associated Press, Merck produces about half of the US annual supply of Hib vaccine.
Government health officials from the CDC and the US Food and Drug Administration (FDA) said in a press teleconference the recall was a precaution and posed no threat to babies and children. The first shot of Hib vaccine is given routinely to babies as young as two months.
In a way the possibility of this recall was forewarned. Last month, Merck reported to the CDC that their "PedvaxHIB vaccine would be unavailable for shipment pending the results of production quality tests", according to a statement on the CDC website. The vaccine would become available again early 2008, but the "exact timing would be dependent on resolution of a manufacturing issue".
The Chicago Tribune reported that federal officials said they had no idea how many of the over one million doses had already been given to children.
The CDC said Merck had assured them there were no reports of "abscesses or disseminated B. cereus infection in children who received vaccines from affected lots". The CDC said the Vaccine Adverse Event Reporting System (VAERS) had also not detected any problems in connection with the vaccines affected by this recall.
If a child were to receive a vaccine that was infected with "B. cereus or microorganisms, there may be a risk of developing localized or disseminated infections", said the CDC. Children with compromised immune systems may experience more serious symptoms. The infections would occur within one week of the vaccination.
In other words, if your child has just had a Hib shot that later is found to have been contaminated, the federal agencies are saying they don't think this will cause more than a minor skin irritation around the area, and this will happen up to one week later. But the infection could be worse for children with weak immune systems.
http://www.medicalnewstoday.com/articles/91632.php 本人已认领该文翻译，如48小时内没有完成，请战友自由认领。 Merck Recalls Over 1 Million Doses Of Children's Vaccine
默克公司召回超过100万剂量的儿童疫苗
The drug company Merck told the US Centers for Disease Control and Prevention (CDC) yesterday, Wednesday 12th December, that it is recalling over one million doses of vaccines routinely given to babies and children. The drug company said it was recalling 10 lots of PedvaxHIB vaccine and 2 lots of Comvax vaccine because they could not assure product sterility.
昨天，周三12月12日，默克制药公司在美国疾病控制及预防中心说，这是召回超过百万剂定期给婴儿和儿童的疫苗，。该制药公司表示，这是召回10个批号的PedvaxHIB疫苗和2个批号的Comvax疫苗，因为他们无法保证产品的无菌。
During a routine standard check on manufacturing equipment used in making the two vaccines, the manufacturer said they found signs of a bacteria called Bacillus cereus. However, when samples of the vaccines were tested before shipment, no such contamination was found. The voluntary recall is purely a precaution, said Merck.
在一次对使用生产这两种疫苗的制造设备例行标准检查，制造商说，他们发现所谓的蜡状芽孢杆菌的细菌迹象。然而，当发运前的疫苗样品进行了测试，这种污染没有被发现。自愿召回纯粹是一项预防措施，默克称。
Both types of vaccine protect against Hib and other conditions. Hib is short for Haemophilus influenzae type b, a serious disease caused by a bacteria that usually strikes children under 5 years old. Comvax also protects against hepatitis B.
这两种疫苗对乙型流感嗜血杆菌和其他条件保护。乙型流感嗜血杆菌是b型流感嗜血杆菌的短型，一个严重的细菌引起的疾病，通常侵犯5岁以下儿童。Comvax还具有乙型肝炎免疫保护。
According to the Associated Press, Merck produces about half of the US annual supply of Hib vaccine.
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作者:admin@医学,生命科学 2011-08-12 05:33
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