疫苗的預防接種對提高人群免疫力、降低人群易感性、控制某些傳染病的發(fā)生和流行起著主導作用。在這次新型冠狀病毒（SARS-CoV-2）疫情防控中，我國政府高度關注疫苗的研發(fā)進展，并在世界研發(fā)行業(yè)中成績卓越。在簡要回顧SARS-CoV-2疫苗的研究進展和從SARS-CoV-2特點再認識疫苗研發(fā)的科學問題的基礎上，從藥物評價研究的角度，就SARS-CoV-2疫苗研發(fā)進展與評價問題予以論述。冠狀病毒疫苗開發(fā)成功的關鍵是產品的安全性和有效性。在其研發(fā)的系統(tǒng)工程中，利用病毒結構的特性，形成新的研發(fā)路征，通過精心設計，嚴格執(zhí)行國內國際研發(fā)評價規(guī)范，進行科學的臨床前質量和穩(wěn)定性試驗、動物的安全性和有效性試驗，進行I、Ⅱ、Ⅲ期臨床評價去實現(xiàn)研發(fā)目標。疫苗從研發(fā)到上市是一個漫長的過程，期間需要解決眾多的關鍵科學問題，尤其是針對像SARS-CoV-2這樣傳播速度快、傳播途徑廣的病毒，可能會面臨更多的風險與挑戰(zhàn)。由于SARS-CoV-2流行范圍廣和變異速度快的特點，為了獲取更全面的病毒數(shù)據(jù)需要國際間的協(xié)調與合作，以確保足夠的信息和研究能力，達到成果國際共享的目的。

Vaccination plays a leading role in improving immunity, reducing susceptibility and controlling the occurrence and prevalence of some infectious diseases. In this epidemic prevention and control of SARS-COV-2, the Chinese government paid more attention to the development progress of vaccine and made outstanding achievements in the world's research and development (R&D) industry. Based on a brief review of the research progress of the novel vaccine and a new understanding of the scientific issues of vaccine R&D based on the characteristics of the novel vaccine, this paper discusses the research progress and evaluation of the novel vaccine from the perspective of drug evaluation. The key to the successful development of a vaccine is the safety and effectiveness of the product. In this system engineering of R&D, the use of virus structure characteristics, forming new development pathway, through elaborate design, strict domestic and international research and evaluation standard, the scientific quality of preclinical quality and stability tests, the safety and effectiveness in animal tests, phase I, Ⅱ and Ⅲ clinical evaluations to achieve development goals. From the research and development to the market of vaccine is a long process, during which many key scientific problems need to be solved. Especially for a SARS-COV-2 such as novel coronavirus that spreads quickly and widely, it may face more risks and challenges. Due to the virus' wide range of popularity and rapid mutation, international coordination and cooperation are needed to obtain more comprehensive virus data, so as to ensure sufficient information and research capacity for the purpose of international sharing of results.