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)
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
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))
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
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(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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