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香港買緊呢三款新型肺炎疫苗

2020/12/13 — 20:58

圖片來源:作者網誌

圖片來源:作者網誌

編按:本港武漢肺炎疫情持續爆發。行政長官林鄭月娥週五表示,已在採購疫苗方面取得進展,包括與 3 種疫苗的研發藥廠簽訂「預購協議」,購買合共逾 2000 萬劑。三種疫苗分別來自中國、美國、德國及英國的藥廠,當中中國藥廠科興控股生物技術公司,將最快在明年 1 月提供首批 100 萬劑疫苗。港大感染及傳染病中心總監何栢良在個人網誌中列出三種疫苗的更多資料。

12.12.2020

食物及衞生局表示,政府與復星醫藥達成協議,將會取得最多750萬劑由 復星與德國藥廠 BioNTech 合作研發的 mRNA 疫苗(即 BNT162b2),供港的疫苗將於歐洲生產;首批100萬劑量預計最快於明年首季交付。局方指,就有關採購協議合約安排,復星醫藥為德國 BioNTech 在中國的戰略合作夥伴,雙方將共同在中國大陸及港澳台地區開發、商業化基於BioNTech專有的mRNA技術研發、針對新冠病毒的mRNA疫苗產品。

廣告

根據協議約定,為本次合作之開發、商業化目的,復星醫藥產業將負責推進該產品於中國的臨床試驗、上市申請、市場銷售;BioNTech將負責提供區域內臨床試驗申請所需的技術材料和臨床前研究資料、配合區域內臨床試驗,並供應該等臨床試驗及市場銷售所需的產品。政府也將購入750萬劑由阿斯利康(AstraZeneca)及牛津大學合作研發的疫苗。有關疫苗預計最快可於明年第二季末起分批運抵本港。基於保密協議,現階段未能公布有關疫苗的生產地資料。(HKG)

11.12.2020

廣告

立法會財務委員會早前已通過撥款約 84 億元,以供採購和注射疫苗之用。政府以最少購入兩款由不同製造商、以不同技術生產的疫苗為目標,採購以全港人口兩倍計算,即1,500萬劑疫苗,供巿民接種;若有關疫苗需要接種兩劑,採購量會相應倍增。林鄭月娥指,政府已與兩間疫苗製造商達成預先採購協議,其中科興控股生物技術有限公司(Sinovac)將向本港供應750萬劑以滅活技術生產的疫苗,首批100萬劑疫苗最快下月送抵本港。

復星醫藥、德國BioNTech和美國輝瑞藥廠(Pfizer)也會提供750萬劑信使核糖核酸(mRNA)疫苗,首批 100 萬劑預料最快明年首季到港。此外,政府快將與英國阿斯利康藥廠(AstraZeneca)達成協議,採購 750 萬劑該藥廠與英國牛津大學共同研發的不可複製性病毒載體疫苗,最快明年下半年供港。林鄭月娥說,政府會全速為本港巿民接種疫苗作好準備。鑑於情況緊急,政府會在香港法例第 599 章《預防及控制疾病條例》下制訂全新規例,盡快為有關疫苗在港註冊。

政府也會籌備按照優先群組次序進行大規模疫苗接種計劃,首先安排醫護人員、長者、長期病患者、安老或殘疾院舍員工等約 300 萬人接種疫苗,目標明年內為全港大部分巿民免費注射疫苗,讓市民盡快恢復日常生活和跨境出行,並使商業活動逐步回復正常。衞生署署長陳漢儀表示,政府洽購的三款疫苗均在第三期臨床試驗中,完成研究乃政府與疫苗製造商協議條件之一。政府經審視有關數據,批准疫苗在港使用後,才會購入疫苗。至於其中一款疫苗須於極低溫環境下貯存,陳漢儀說,政府已要求供應者分批供應疫苗,並確保物流過程符合有關溫度要求。(HKG)

PFIZER-BIONTECH COVID-19 VACCINE

PubMed search: BNT162b2

Full prescribing information (link)

12.12.2020 The Pfizer-BioNTech COVID-19 Vaccine is authorized for use under an Emergency Use Authorization (EUA) for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 16 years of age and older. (Pfizer press release)

10 Dec 2020 NEJM

IMPORTANT SAFETY INFORMATION:

● Do not administer Pfizer BioNTech COVID-19 Vaccine to individuals with known history of a severe allergic reaction (e.g., anaphylaxis) to any component of the Pfizer BioNTech COVID-19 Vaccine
● Appropriate medical treatment used to manage immediate allergic reactions must be immediately available in the event an acute anaphylactic reaction occurs following administration of Pfizer BioNTech COVID-19 Vaccine
● Immunocompromised persons, including individuals receiving immunosuppressant therapy, may have a diminished immune response to the Pfizer BioNTech COVID-19 Vaccine
● The Pfizer BioNTech COVID-19 Vaccine may not protect all vaccine recipients
● In clinical studies, adverse reactions in participants 16 years of age and older included pain at the injection site (84.1%), fatigue (62.9%), headache (55.1%), muscle pain (38.3%), chills (31.9%), joint pain (23.6%), fever (14.2%), injection site swelling (10.5%), injection site redness (9.5%), nausea (1.1%), malaise (0.5%), and lymphadenopathy (0.3%)
● Severe allergic reactions have been reported following the Pfizer-BioNTech COVID-19 Vaccine during mass vaccination outside of clinical trials. Additional adverse reactions, some of which may be serious, may become apparent with more widespread use of the Pfizer-BioNTech COVID-19 Vaccine
● Available data on Pfizer BioNTech COVID-19 Vaccine administered to pregnant women are insufficient to inform vaccine-associated risks in pregnancy
● Data are not available to assess the effects of Pfizer BioNTech COVID-19 Vaccine on the breastfed infant or on milk production/excretion
● There are no data available on the interchangeability of the Pfizer BioNTech COVID 19 Vaccine with other COVID-19 vaccines to complete the vaccination series. Individuals who have received one dose of Pfizer BioNTech COVID-19 Vaccine should receive a second dose of Pfizer BioNTech COVID-19 Vaccine to complete the vaccination series
● Vaccination providers must report Adverse Events in accordance with the Fact Sheet to VAERS at https://vaers.hhs.gov/reportevent.html or by calling 1-800-822-7967. The reports should include the words “Pfizer-BioNTech COVID-19 Vaccine EUA" in the description section of the report
● Vaccination Providers should review the Fact Sheet for mandatory requirements and Information to Provide to Vaccine Recipients/Caregivers and the Full EUA Prescribing Information for Requirements and Instructions for Reporting Adverse Events and Vaccine Administration Errors

1.12.2020 ACIP interim guidelines on allocation of COVID-19 vaccine (link)

AstraZeneca-Oxford (AZD1222)

PubMed search: AZD1222

Voysey, M., Clemens, S. A. C., Madhi, S. A. & other authors (2020). Safety and efficacy of the ChAdOx1 nCoV-19 vaccine (AZD1222) against SARS-CoV-2: an interim analysis of four randomised controlled trials in Brazil, South Africa, and the UK. Lancet. 8 Dec 2020 (link)

科興生物: 克爾來福

PubMed search: SinoVax

Zhang, Y., Zeng, G., Pan, H. & other authors (2020). Safety, tolerability, and immunogenicity of an inactivated SARS-CoV-2 vaccine in healthy adults aged 18-59 years: a randomised, double-blind, placebo-controlled, phase 1/2 clinical trial. Lancet Infect Dis. 17 Nov 2020

Last updated 13 Dec 2020

 

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