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Rotarix Vaccine recalled

  1. #1
    syuan is offline Registered User
    Join Date
    May 2007

    Rotarix Vaccine recalled

    FYI, received a phone call and email from our pediatrician's clinic.

    Dear Parents/patients,
    Recall of Rotarix (rotavirus) Vaccine
    On 23 March 2010, the Department of Health has announced that Rotarix, a rotavirus vaccine manufactured by GSK, be recalled due to safety concerns. FDA has made an announcement earlier, that they have discovered Rotarix to be contaminated by DNA material of PCV1 (porcine circovirus 1), a virus that infects pigs but not humans.
    Although they agreed that there was no safety risks, the FDA recommended that doctors suspend using Rotarix until more is known about the contamination. We have therefore followed the DH recall and the FDA warning, and have returned all Rotarix vaccines to the manufacturer. We have the following recommendations to all parents concerned.

    1. If your baby has received the full course of Rotarix (2 doses) already, there is NOTHING you need to do and there should not be any concern, since PCV1 does not affect humans.
    2. If your baby has received 1 dose of Rotarix (usually at 2-3 months) but is not yet due for the second dose, you have the following choices:
    i. Take 2 more doses of Rotateq (MSD rotavirus vaccine) to complete the course, at 4 and 6 months, or
    ii. Forget about receiving the vaccine altogether.
    3. If your baby has received Rotateq, there is no need to panic. The contamination only involves Rotarix.
    4. We are in the process of contacting all affected families.
    5. We will keep you duly informed of the progress of the issue.

    Our staff will be happy to assist you, please call the clinic at 2526 6332,

    回收羅特律Rotarix (輪狀病毒) 疫苗
    衛生署於2010年10月23日宣佈因安全問題,回收葛蘭素史克藥廠GSK生產的「羅特律輪狀病毒疫苗口服 懸液劑」(Rotarix)。美國食物及藥物管理局證實在Rotarix疫苗發現含有第一型豬 環狀病毒 (簡稱PCV1) 的去氧核糖核酸(DNA),此病毒只引發豬隻疾病,並不影響人類。
    美國食物及藥物管理局表明並無證據顯示Rotarix存在安全風險,但仍建議醫生在當局繼續調查期間暫時停 用該疫苗。本診所接受衛生署及美國食物及藥物管理局建議,把Rotarix疫苗全部退回生產商,並對關注此 事件之家長提供以下建議:
    1. 如嬰兒已完成兩劑Rotarix疫苗,無需採取任何措施亦無需擔心,因為人類不會因感染PCV1病毒而致病 。
    2. 如嬰兒 (約在2-3個月齡) 已接受一劑Rotarix疫苗,但仍未到期接受第二劑,家長可選擇:
    i. 在嬰兒4及6個月大時接受兩劑由MSD藥廠生產的Rotateq輪狀病毒疫苗;或
    3. 如嬰兒已接受Rotateq輪狀病毒疫苗,則無需擔心,因PCV1病毒只在Rotarix疫苗 中發現。
    4. 我們正逐步與受影響的家庭聯絡。
    5. 如有進一步消息,我們會盡快發出通知。
    本醫務所職員將樂意為您講解及安排,詳情請致電2526 6332。

    With best regards
    Drs Alfred Tam, Susanna Chow, Mark Chan, VK Sugunan & all 818 staff.
    ++++++++++++++++++++++++++++++++++++++++++++++++++ +++++++
    Children at 818
    Suite 818, Central Building
    1 Pedder Street, Central
    Hong Kong
    T : 852 -2526 6332
    F : 852- 2523 3310
    E : [email protected]
    W: Children818

  2. #2
    babycakes is offline Registered User
    Join Date
    Jul 2007
    Hong Kong

    thank you for posting this!!!

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