疫苗的預(yù)防接種對(duì)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(dǎo)作用。在這次新型冠狀病毒（SARS-CoV-2）疫情防控中，我國(guó)政府高度關(guān)注疫苗的研發(fā)進(jìn)展，并在世界研發(fā)行業(yè)中成績(jī)卓越。在簡(jiǎn)要回顧SARS-CoV-2疫苗的研究進(jìn)展和從SARS-CoV-2特點(diǎn)再認(rèn)識(shí)疫苗研發(fā)的科學(xué)問(wèn)題的基礎(chǔ)上，從藥物評(píng)價(jià)研究的角度，就SARS-CoV-2疫苗研發(fā)進(jìn)展與評(píng)價(jià)問(wèn)題予以論述。冠狀病毒疫苗開(kāi)發(fā)成功的關(guān)鍵是產(chǎn)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(jié)構(gòu)的特性，形成新的研發(fā)路征，通過(guò)精心設(shè)計(jì)，嚴(yán)格執(zhí)行國(guó)內(nèi)國(guó)際研發(fā)評(píng)價(jià)規(guī)范，進(jìn)行科學(xué)的臨床前質(zhì)量和穩(wěn)定性試驗(yàn)、動(dòng)物的安全性和有效性試驗(yàn)，進(jìn)行I、Ⅱ、Ⅲ期臨床評(píng)價(jià)去實(shí)現(xiàn)研發(fā)目標(biāo)。疫苗從研發(fā)到上市是一個(gè)漫長(zhǎng)的過(guò)程，期間需要解決眾多的關(guān)鍵科學(xué)問(wèn)題，尤其是針對(duì)像SARS-CoV-2這樣傳播速度快、傳播途徑廣的病毒，可能會(huì)面臨更多的風(fēng)險(xiǎn)與挑戰(zhàn)。由于SARS-CoV-2流行范圍廣和變異速度快的特點(diǎn)，為了獲取更全面的病毒數(shù)據(jù)需要國(guó)際間的協(xié)調(diào)與合作，以確保足夠的信息和研究能力，達(dá)到成果國(guó)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.