已經發表第三期臨床試驗報告且台灣可取得之COVID-19疫苗介紹

Introduction of Currently (2021) Available COVID-19 Vaccine in Taiwan

陳易宏(I-Hung Chen) ； 陳信均(Hsing-Chun Chen)

《內科學誌》 32卷6期 (2021/12) Pp. 440-447

https://doi.org/10.6314/JIMT.202112_32(6).06

摘要

台灣面對COVID-19疫情，採取了嚴控國境與戴口罩維持社交距離的方式獲得防疫的成功，但全世界的經濟都因實施了相當程度限制人員流動與接觸的措施，而受到巨大的衝擊。由於COVID-19的致病率與致死率皆高，且目前沒有特效藥，普遍施打有效疫苗應該是達成群體免疫並控制疫情的重要選項。目前已在經同儕審核的期刊上發布第三期臨床試驗報告的疫苗有Oxford/AstraZeneca的ChAdOx1 nCoV-19，Pfizer/BioNTech的BNT162b2，Moderna的mRNA-1273，以及Gamaleya的Sputnik V。這幾支疫苗的效力（efficacy）都在70%-95%之間，且已經取得至少一國之緊急使用許可。但這些疫苗的副作用比季節性流行性感冒疫苗多，例如：接種Moderna mRNA-1273疫苗的受試者有59%的機會產生任何一種第二級或第三級的副作用。而且這些疫苗都使用了在2020年以前完全沒有大規模臨床測試過的新技術（腺病毒載體疫苗與信使核醣核酸疫苗），因此長期安全性及罕見嚴重副作用尚未完全明朗。但考量到未來開放國境後很可能產生社區感染，因此第一線醫護人員與防疫人員、長期照顧機構之住民及其照顧者、以及COVID-19重症的高風險族群是否應該在今年接受疫苗接種，是值得討論的問題。本文除了介紹這些疫苗的效果與副作用之外，也會簡單提及台灣自主研發COVID-19疫苗的進度。

關鍵字

嚴重特殊傳染性肺炎（Coronavirus disease 2019, COVID-19） ； 嚴重急性呼吸道症候群冠狀病毒第二型（Severe acute respiratory syndrome coronavirus 2, SARS-CoV-2） ； 群體免疫（Herd immunity） ； 疫苗（Vaccine） ； 腺病毒載體疫苗（Adenoviral vector vaccine） ； 信使核糖核酸疫苗（mRNA vaccine）

並列摘要

Taiwan's response to the COVID-19 epidemic has successfully controlled the outbreak by tightly controlling its borders, wearing masks, and maintain physical distancing. Given the high pathogenicity and mortality of COVID-19 and the absence of an effective drug, an effective vaccine should be an important strategy to achieve herd immunity. Phase III clinical trials have been published in peer-reviewed journals for Oxford/AstraZeneca's ChAdOx1 nCoV-19, Pfizer/BioNTech's BNT162b2, Moderna's mRNA-1273, and Gamaleya's Sputnik V. All of these vaccines have an efficacy of 70%-95% and have been licensed for emergency use in at least one country. However, these vaccines have more side effects than the seasonal influenza vaccine, e.g., subjects who received Moderna mRNA-1273 had a 59% chance of developing any of the Grade II or III side effects. Moreover, these vaccines use new vaccine technologies (adenoviral vector vaccine and messenger RNA vaccine) that have not been clinically tested on a large scale before the current outbreak. Therefore, the long-term safety profile and rare but severe side effects are not fully understood. However, given the likelihood of local transmission and community spread after the opening of the border. We should consider whether health care workers, residents of long-term care facilities and their caregivers, and high-risk groups with severe COVID-19 disease should receive vaccinations this year. In addition to introducing the effects and side effects of these approved vaccines, this article will also briefly mention the progress of Taiwan's independent research and development of the COVID-19 vaccine.