FDA experts voted for approval of Cervarix ™. The Advisory Committee belonged to the Office of the Food and Drug Administration USA (FDA) voted unanimously that the data of clinical studies should speak in favor of the efficacy and safety of the vaccine Cervarix ™ produced by GlaxoSmithKline Co as a means of prevention cervical cancer and precancerous lesions caused by human papilloma virus 16 th and 18 th types of girls and young women.
As it was pointed at the meeting of the committee board, while some clinical data suggested that Cervarix was safe, there shall be held follow-up study to trace the development of potential adverse events including pregnancy, miscarriage and problems associated with inflammation of muscles; the problems that were noted in a small number of patients. However, experts pointed out that the relationship between these phenomena and the vaccine usage is unlikely. One member, Kenneth Noller mentioned that the study of this vaccine safety in pregnant women has not been done and it was not considered to study among this category of patients.
In conclusion, FDA, released last week, management experts said that Cervarix has a favorable risk / benefit ratio. FDA may officially endorse the use of the product to vaccinate girls and women aged 10-25 years to 29 September this year.
Tags: cervarix, FDA, cervical cancer, precancerous lesions, papilloma virus, |
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