ST LOUIS (MD Consult) - On March 22, 2010, the US Food and Drug Administration (FDA) advised clinicians to temporarily suspend use of the Rotarix vaccine while the agency learns more about components of an extraneous virus detected in the product. At this time, no evidence exists to show that this finding poses a safety risk.

Rotarix is a 2-dose orally administered vaccine given to young infants to prevent rotavirus disease, which can cause severe diarrhea and dehydration.

The FDA recently became aware that an independent US academic research team, using a novel technique, has found DNA from porcine circovirus 1 (PCV1) in Rotarix, which is manufactured by GlaxoSmithKline (GSK). The researchers detected DNA fragments of PCV1 in 2 lots of the Rotarix vaccine. The presence of this DNA in the vaccine has been confirmed by additional tests conducted by GSK and the FDA.

Porcine circovirus 1 is not known to multiply in humans nor to cause illness in humans. It is found in everyday meat products and is frequently eaten with no resultant disease or illness. At this time, the FDA does not know how DNA from PCV1 came to be present in Rotarix.

In its follow-up assessments of Rotarix, GSK detected the presence of DNA from PCV1 in the working cell bank and viral "seed" used to produce the vaccine, confirming that the material has been present since the early stages of product development, including during clinical studies. According to the FDA, Rotarix has been studied extensively, before and after approval, and has been found to have an excellent safety record.

The FDA plans to continue gathering more information about the PCV1 components in Rotarix, including whether intact virus, as opposed to DNA fragments, is present. The agency is also assessing current vaccine testing methods.

Preliminary testing by both the academic researchers and FDA scientists of another licensed vaccine against rotavirus infection, RotaTeq, has not detected components of PCV1.

 

圣路易斯(MD Consult)——2010年3月22日，美国食品药品管理局(FDA)在获知Rotarix疫苗中检测出其他病毒成分的同时，建议临床医生暂停使用该疫苗。目前，尚无证据显示该结果可引发安全风险。

 

Rotarix是一种两剂口服疫苗，适用于婴幼儿以预防轮状病毒病，该病可导致重度腹泻和脱水。

Rotarix是由葛兰素史克公司(GSK)生产的疫苗。FDA最近获知，美国一支独立的学术研究团队使用一项新技术从Rotarix中发现了猪圆环病毒1型(PCV1)的DNA。研究者们在2个批次的Rotarix疫苗中均检出了PCV1的DNA片段。GSK和FDA通过进行其他检测证实了疫苗中存在这种DNA。

 

尚不清楚猪圆环病毒1型能否在人类繁殖，亦不知是否会在人类中致病。该病毒存在于日常肉制品中，经常被食入体内，但并未因此致病或引起不适。当下，FDA对PCV1 的DNA如何出现在Rotarix中仍无答案。

在对Rotarix的下一步评估中，GSK从工作细胞库和用于繁殖疫苗的病毒“种子”中检出了PCV1的DNA，从而证实该物质自此产品的研发初期(包括临床研究期间)起就一直存在。据FDA称，无论在批准之前抑或之后对Rotarix均进行了广泛研究， 而且发现该疫苗有着极好的安全记录。

FDA计划继续收集更多有关Rotarix中PCV1成分的资料，包括相对于DNA片段，是否存在完整病毒。FDA也在评估当前的疫苗检测法。

学术研究者和FDA科学家对另一种获准的对抗轮状病毒感染的疫苗RotaTeq进行了初步检测，未检出PCV1成分。