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Updated information on Coronavirus Disease 2019 (COVID-19) and vaccines - 29 Mar 2021

29 Mar 2021

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Dear Staff and Students,

We would like to share the following message on Coronavirus Disease 2019 (COVID-19) from Department of Health about Updated information on Coronavirus Disease 2019 (COVID-19).

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Health, Safety and Environment Office 

 


Dear Sir/Madam,

Updated information on Coronavirus Disease 2019 (COVID-19) and vaccines

1. Government announces initial investigation results regarding packaging defects of BioNTech vaccine

The Department of Health (DH) had earlier noticed that there was an accumulated number of cases of packaging defects (including loose vial caps, leakages from the vials, etc.) regarding the BioNTech vaccines (batch no. 210102). The DH immediately notified the vaccine supplier (Fosun Industrial Co., Limited (Fosun) and German drug manufacturer BioNTech) and requested for prompt follow-up. At the same time, in view that the supplier has launched an urgent and comprehensive investigation on the packaging defects, the Government agreed to the supplier's recommendation and suspended vaccination of batch 210102 and 210104 of the BioNTech vaccines in Hong Kong for the sake of prudence and as a precautionary measure.

According to the initial investigation results, Fosun and German drug manufacturer BioNTech considered that there is no evidence indicating any safety risks of the BioNTech vaccines delivered to Hong Kong (batch no. 210102 and 210104). Members of the public who have received the BioNTech vaccines do not need to worry. The subsequent investigation work will mainly target on ascertaining the integrity of the intrinsic properties of the relevant batches of vaccine, and that the batches are safe for use.

Premised on the condition of safety, the Government will strive to resume the administration of the BioNTech vaccine for members of the public as soon as possible, so as to protect public health and the health of citizens.

For details, please refer to the press release:

https://www.info.gov.hk/gia/general/202103/27/P2021032700785.htm

2. Safety monitoring of COVID-19 vaccines

DH has put in place a pharmacovigilance system for COVID-19 immunization, including receiving reports of Adverse Events Following Immunization (“AEFIs”) related to the COVID-19 vaccines used in Hong Kong from healthcare professionals and pharmaceutical industries.

Pursuant to the requirements of the Prevention and Control of Disease (Use of Vaccines) Regulation, Cap. 599K to monitor any adverse event that occurs to the recipient associated with the administration of the relevant vaccine, the Director of Health appointed the Expert Committee on Clinical Events Assessment Following COVID-19 Immunization (“Expert Committee”) to provide independent assessment of potential causal link between AEFIs and COVID-19 vaccines used in Hong Kong and to provide expert advice to the Government on safety-related matters. The Department of Health also partners with the University of Hong Kong to conduct an active surveillance programme for Adverse Events of Special Interest (“AESIs”) related to COVID-19 vaccines.

Thematic webpage:

https://www.covidvaccine.gov.hk/en/vaccine

Report on the Safety Monitoring of COVID-19 Vaccines in Hong Kong (updated regularly):

https://www.drugoffice.gov.hk/eps/do/en/doc/Safety_Monitoring_of_COVID-19_Vaccines_in_Hong_Kong.pdf

3. Multilingual information

To facilitate more ethnic minorities to receive the Government’s latest information, various materials on COVID-19 vaccine safety monitoring and fact sheets etc. have been translated into multiple languages. For details, please refer to the attachment.

We would like to solicit your support to disseminate the information to your colleagues, work associates and/or business partners so that they could adopt proper preventive measures. Thank you very much for your support.
Department of Health

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敬啟者:

2019冠狀病毒病及疫苗的最新資訊

1. 政府就復必泰疫苗包裝瑕疵公布初步調查結果

早前衞生署發現復必泰疫苗(批次210102)累計多宗包裝瑕疵(包括藥瓶封蓋鬆脫、藥瓶出現滲漏等),已即時通報疫苗供應商(復星實業(香港)有限公司(復星)及德國藥廠BioNTech)並要求立刻跟進。同時,因應供應商就包裝瑕疵展開緊急和全面調查,為謹慎起見及作為預防性措施,政府同意供應商建議,暫停批次210102及210104復必泰疫苗在港接種。

根據初步調查結果,供應商認為沒有證據顯示已抵港的復必泰疫苗存在安全風險,已接種復必泰疫苗的市民無需擔心,後續調查工作主要以查證相關疫苗批次並無任何固有特性問題而可繼續安全使用為目標。

政府會以安全為大前提,務求盡早恢復為市民接種復必泰疫苗,保障公共衞生和市民健康。

詳情參閱新聞公報:

https://www.info.gov.hk/gia/general/202103/27/P2021032700643.htm

2. 新冠疫苗的安全監察

衞生署一直密切監察接種新冠疫苗後可能出現的異常事件,包括加強現行的恆常監測及作出主動監測。

衞生署為接種新冠疫苗異常事件設有藥物安全監測系統,收集醫護人員及藥劑業界所呈報在香港使用的新冠疫苗接種異常事件報告。
衞生署署長根據香港法例第 599K 章《預防及控制疾病(使用疫苗)規例》就監察接種有關疫苗接種異常事件的要求,成立了「新冠疫苗臨床事件評估專家委員會」。專家委員會會對香港使用的新冠疫苗接種異常事件的因果關係和潛在關聯進行獨立評估,並就新冠疫苗的安全相關議題向政府提供專家意見。另外,衞生署亦與香港大學合作主動監測新冠疫苗接種關注事件。

專題網頁:

https://www.covidvaccine.gov.hk/zh-HK/vaccine

香港新冠疫苗的安全監察報告(定期更新):

https://www.drugoffice.gov.hk/eps/do/tc/doc/Safety_Monitoring_of_COVID-19_Vaccines_in_Hong_Kong.pdf

3. 多國語言資訊

為便利更多少數族裔人士接收政府最新的防疫信息,有關新冠疫苗安全監察和接種須知等資訊已翻譯成多國語言,詳情可參閱附件。

希望你可以將有關資訊與你的同事、合作者及/或業務伙伴分享,讓他們都能採取合適的預防措施。非常感謝你的支持。

衞生署


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