FDA Panel Backs Glaxo Infant Vaccine
Wednesday February 20, 4:43 pm ET
FDA Experts Say GlaxoSmithKline Vaccine to Prevent Diarrhea Virus Is Safe and Effective
WASHINGTON (AP) -- Government advisers said Wednesday a GlaxoSmithKline vaccine is safe and effective for stopping the leading cause of diarrhea in infants.
The Food and Drug Administration's panel of vaccine experts voted unanimously that Glaxo's Rotarix protects infants against rotavirus. The panel voted 11 to 1 that the product is safe for use in babies as young as six weeks old.
FDA is not required to follow the advice of its panelists, though it usually does.
Agency reviewers said prior to the meeting that Rotarix appeared to be free of life-threatening intestinal problems seen with the first rotavirus vaccine approved in the U.S. That product, Wyeth's RotaShield, was pulled from the market in 1999 after it was linked to an increase in intussusception, a twisting of the intestines.
In a Glaxo study of more than 63,000 babies, those who received the two-injection vaccine did not have a higher rate of intestinal problems than those injected with placebo.
Glaxo's vaccine is expected to compete against Merck & Co.'s RotaTeq, a similar product approved by FDA in 2006.
About 55,000 U.S. children are hospitalized each year due to the rotavirus, according to the Centers for Disease Controls. The U.S. government and several medical societies already recommend infants receive vaccination for rotavirus at two, four and six months.
Rotarix is already available in more than 90 countries worldwide, according to Glaxo.
Shares of GlaxoSmithKline PLC fell 44 cents Wednesday to $44.31.
本人已认领该文编译，48小时后若未提交译文，请其他战友自由认领。
华盛顿政府顾问周三说一种GSK疫苗在阻止婴幼儿主要腹泻中安全有效。
FDA疫苗评审组全体专家投票无异议地通过Glaxo公司的Rotarix疫苗能保护婴幼儿预防轮状病毒。以11票对1票通过这种产品可以在6周以上婴儿中安全使用。
FDA虽然不需要遵从评审组建议但通常是遵从的。
代理处评论说在Rotarix确定没有危及生命的肠道问题的公开会之前美国曾批准第一个轮状病毒疫苗—Wyeth公司的Rotashield，于1999年因为发现它导致肠套叠发生增多而撤出市场。
在Glaxo公司的研究中，超过63000位婴儿接受两次疫苗注射，于安慰剂比较肠道问题发病率没有增高。
Glaxo的疫苗和FDA2006年批准的的Merk有限公司的Rotateq可以一比上下。
根据疾控中心的资料，美国每年大概有55000名儿童因为轮状病毒住院治疗。美国政府和一些医疗机构早就建议婴儿在2、4、6月接种轮状病毒疫苗。
Glaxo公司透露全世界超过90个国家可以使用到Rotarix疫苗。
周三GSK下降44美分达44.31美元每份。
Wednesday February 20, 4:43 pm ET
FDA Experts Say GlaxoSmithKline Vaccine to Prevent Diarrhea Virus Is Safe and Effective
WASHINGTON (AP) -- Government advisers said Wednesday a GlaxoSmithKline vaccine is safe and effective for stopping the leading cause of diarrhea in infants.
The Food and Drug Administration's panel of vaccine experts voted unanimously that Glaxo's Rotarix protects infants against rotavirus. The panel voted 11 to 1 that the product is safe for use in babies as young as six weeks old.
FDA is not required to follow the advice of its panelists, though it usually does.
Agency reviewers said prior to the meeting that Rotarix appeared to be free of life-threatening intestinal problems seen with the first rotavirus vaccine approved in the U.S. That product, Wyeth's RotaShield, was pulled from the market in 1999 after it was linked to an increase in intussusception, a twisting of the intestines.
In a Glaxo study of more than 63,000 babies, those who received the two-injection vaccine did not have a higher rate of intestinal problems than those injected with placebo.
Glaxo's vaccine is expected to compete against Merck & Co.'s RotaTeq, a similar product approved by FDA in 2006.
About 55,000 U.S. children are hospitalized each year due to the rotavirus, according to the Centers for Disease Controls. The U.S. government and several medical societies already recommend infants receive vaccination for rotavirus at two, four and six months.
Rotarix is already available in more than 90 countries worldwide, according to Glaxo.
Shares of GlaxoSmithKline PLC fell 44 cents Wednesday to $44.31.
本人已认领该文编译，48小时后若未提交译文，请其他战友自由认领。
华盛顿政府顾问周三说一种GSK疫苗在阻止婴幼儿主要腹泻中安全有效。
FDA疫苗评审组全体专家投票无异议地通过Glaxo公司的Rotarix疫苗能保护婴幼儿预防轮状病毒。以11票对1票通过这种产品可以在6周以上婴儿中安全使用。
FDA虽然不需要遵从评审组建议但通常是遵从的。
代理处评论说在Rotarix确定没有危及生命的肠道问题的公开会之前美国曾批准第一个轮状病毒疫苗—Wyeth公司的Rotashield，于1999年因为发现它导致肠套叠发生增多而撤出市场。
在Glaxo公司的研究中，超过63000位婴儿接受两次疫苗注射，于安慰剂比较肠道问题发病率没有增高。
Glaxo的疫苗和FDA2006年批准的的Merk有限公司的Rotateq可以一比上下。
根据疾控中心的资料，美国每年大概有55000名儿童因为轮状病毒住院治疗。美国政府和一些医疗机构早就建议婴儿在2、4、6月接种轮状病毒疫苗。
Glaxo公司透露全世界超过90个国家可以使用到Rotarix疫苗。
周三GSK下降44美分达44.31美元每份。