新药跟踪~新联合疫苗通过

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FDA前日通过了一个乙肝+另外4种儿童疾病的联合疫苗, Pediarix. 在注射接种乙肝疫苗时可以同期注射接种白, 百, 破, 小儿麻痹. 疫苗还是分三次, 三针接种(一般在出生后6个月内完成), 这样政府, 保险, 医院在接种疫苗时候可以省去经费, 时间. 让疫苗变成政府或保险机构的必付金额. 其实, 更重要的是将乙肝预防, 疫苗划分为儿童出生后, 进入幼儿园, 学前班的必须之程序.

在圣诞节前后的一次医院活动中, 听说厂方已经和中国方面联系希望能够将技术或药品用在中国儿童身上. 但是中方没有回复. 希望, 国际基金会能够将这个疫苗带入中国.


FDA原文:


New Combination Vaccine Protects Against Hepatitis B and Four Other Childhood Diseases

FDA has approved Pediarix, a new combination vaccine that protects infantsagainst diphtheria, tetanus, pertussis (whooping cough), polio, and disease due to the hepatitis B virus. The vaccine combination effectively reduces the number of injections needed for the same protection from nine to three.

The Food and Drug Administration (FDA) today announced the approval of a new combination vaccine that protects infants against diphtheria, tetanus, pertussis (whooping cough), polio, and disease due to the Hepatitis B virus. The vaccine will be marketed as Pediarix by SmithKline Beecham Pharmaceuticals.

Pediarix is the only vaccine marketed in the U.S. that contains DTaP (Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed), Hepatitis B Vaccine (Recombinant], and Inactivated Poliovirus Vaccine (IPV) for administration as one intramuscular injection. The specific DTaP (Infanrix) and Hepatitis B (Engerix-B) components used in Pediarix were previously licensed in the U.S.

DtaP vaccine, Hepatitis B vaccine and IPV are all currently available in the U.S. as separate vaccines. A Hepatitis B (recombinant) and Haemophilus influenza type b combination vaccine is also available in the U.S.

Pediarix is recommended for administration as a 3-dose primary series to infants at approximately 2, 4, and 6 months of age. When DtaP, Hepatitis B and IPV vaccines are administered separately, in the same time frame, infants receive 9 injections.

Pediarix should not be administered to infants before the age of 6 weeks, and therefore is not indicated for infants born to mothers who are infected with Hepatitis B or whose Hepatitis B status is unknown. Such infants should receive Hepatitis B Vaccine shortly after birth and complete their immunization according to a particular schedule.

In a trial with the administration of the vaccine at 2, 4, and 6 months of age, Pediarix-induced immune responses were generally similar to those induced by separately administered licensed vaccines. The most frequently reported adverse reactions to Pediarix were local injection site reactions (pain, redness, swelling), fever, and fussiness. In clinical studies, fever occurred more frequently after administration of Pediarix than separately administered licensed vaccines.

Inoculations have played a critical role in protecting individuals from potentially deadly diseases. In addition, vaccines safeguard the public from infectious diseases, proportionately decreasing the risk of disease spreading as vaccination rates increase. Children caregivers should consult with their healthcare providers for more information on vaccine protection.

01/03/03

Source
US Food and Drug Administration