2020-12-13

肺炎系列 (四百一十三) 香港採購冠狀病毒疫苗的資料



香港政府在2020年12月11日宣布已經初步達成協議,包括Sinovac、BioNTech、Pfizer、AstraZeneca的疫苗 [註一],其實正正是分別為三種平台。

在世界衞生組織的平台裏,知道已經有51隻進入人類臨床測試,臨床測試分為第一期、第二期、第三期,第三期就是比較成熟,即是已經接近可以註冊。在第三期臨床方面,現時我們有13隻疫苗,這13隻疫苗中亦有四種不同的技術平台,所謂不同的technology platform,分別有「滅活」(inactivated)、「病毒載體」(viral vector)、「核酸疫苗」(nucleic acid vaccine)和一個蛋白質亞單元疫苗(protein subunit)。

[註一] 行政長官抗疫記者會答問內容。香港政府新聞公報 2020-12-11

我建議各位去閱讀冠狀病毒疫苗的研究報告,比較接近第一手資料,報導的都是轉載節錄的第二三手消息。我為大家整理以下資料。

 


   

Sinovac

CoronaVac (Sinovac Life Sciences, Beijing, China)
  • an inactivated vaccine candidate against COVID-19, containing inactivated severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)
  • phase 1/2 clinical trial, healthy adults aged 18–59 years
  • 743 participants received at least one dose of investigational product (n=143 for phase 1 and n=600 for phase 2; safety population)
Yanjun Zhang et al. 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. The Lancet infectious diseases 2020-11-17

   

Pfizer-BioNTech

  • The vaccine is based on the SARS-CoV-2 spike glycoprotein (S) antigen encoded by RNA and formulated in lipid nanoparticles (LNPs). 
  • in individuals 16 years of age and older.
  • The proposed dosing regimen is 2 doses, 30 µg each, administered 21 days apart.
  • A phase 3 randomized and placebo-controlled trial using BNT162b2 in approximately 44,000 participants is currently ongoing to evaluate the vaccine’s safety and efficacy
  • In N=37,706 participants, the duration of follow-up was ≥2 months post Dose 2 for 50.6% of participants. Duration of follow up was ≥1 month post Dose 2 for 91.6% of participants
Fernando P. Polack et al. Safety and Efficacy of the BNT162b2 mRNA Covid-19 Vaccine. NEJM 2020-12-10PFIZER-BIONTECH COVID-19 VACCINE (BNT162, PF-07302048) VACCINES AND RELATED BIOLOGICAL PRODUCTS ADVISORY COMMITTEE BRIEFING DOCUMENT MEETING 2020-12-10

  

AstraZeneca

  • The ChAdOx1 nCoV-19 vaccine (AZD1222) was developed at Oxford University and consists of a replication-deficient chimpanzee adenoviral vector ChAdOx1, containing the SARS-CoV-2 structural surface glycoprotein antigen (spike protein; nCoV-19) gene.
  • phase 2/3 trials in the UK and Brazil, and safety data from more than 20000 participants
  • The vaccine can be stored and distributed at 2–8°C
  • 18–55-year-old cohorts... aged 55–69 years and those aged 70 years or older (COV002 (UK))
 

第二三手消息


 
科興、輝瑞、牛津三大疫苗 一文看懂主要分別。經濟日報 2020-12-12

What are phase 1/2/3 clinical trials?

Phase one
  • Study Participants: 20 to 100 healthy volunteers or people with the disease/condition.
  • Length of Study: Several months
  • Purpose: Safety and dosage
Phase two
  • Study Participants: Up to several hundred people with the disease/condition.
  • Length of Study: Several months to 2 years
  • Purpose: Efficacy and side effects
Phase three
  • Study Participants: 300 to 3,000 volunteers who have the disease or condition
  • Length of Study: 1 to 4 years
  • Purpose: Efficacy and monitoring of adverse reactions
Step 3: Clinical Research. US FDA 2018-04-01
 

   

沛然有關疫苗的文章

流感疫苗
我在立法會的工作 - 質詢有關接種流感疫苗人數及覆蓋率 2020-11-20我在立法會的工作 - 質詢有關流感疫苗 2020-11-20要求政府為參與幼稚園/幼兒中心外展接種計劃的私家醫生提供疫苗 2020-07-16

麻疹
香港人的麻疹 2018-10-24

甲型肝炎 十問十答 2015-04-15


(特別鳴謝感染及傳染病科專科陳醫生的資料提供)

Dr. Pierre Chan

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