FDA STATEMENT on Following the Authorize

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FDA Statement on Following the Authorized Dosing Schedules for COVID-19 Vaccines

FDA关于遵循新冠疫苗接种剂量时间表的声明

For Immediate Release:

January 04, 2021

Statement From:

Commissioner of Food and Drugs - Food and Drug Administration

Stephen M. Hahn M.D.

Director - Center for Biologics Evaluation and Research (CBER)

Peter Marks M.D., PhD.

Two different mRNA vaccines have now shown remarkable effectiveness of about 95% in preventing COVID-19 disease in adults. As the first round of vaccine recipients become eligible to receive their second dose, we want to remind the public about the importance of receiving COVID-19 vaccines according to how they’ve been authorized by the FDA in order to safely receive the level of protection observed in the large randomized trials supporting their effectiveness.

两种不同的mRNA疫苗在预防成人COVID-19疾病方面显示出约95%的显著效果。随着第一轮疫苗接种者有资格获得第二次剂量，根据疫苗是如何被FDA授权，为了在支持疫苗有效性的大量随机试验中安全地接受所观察到的保护水平，我们想要提醒公众接种新冠疫苗的重要性。

We have been following the discussions and news reports about reducing the number of doses, extending the length of time between doses, changing the dose (half-dose), or mixing and matching vaccines in order to immunize more people against COVID-19. These are all reasonable questions to consider and evaluate in clinical trials. However, at this time, suggesting changes to the FDA-authorized dosing or schedules of these vaccines is premature and not rooted solidly in the available evidence. Without appropriate data supporting such changes in vaccine administration, we run a significant risk of placing public health at risk, undermining the historic vaccination efforts to protect the population from COVID-19.

我们一直关注有关减少剂量，延长剂量间隔时间，改变剂量（剂量减半），或是混合和匹配疫苗来使更多的人免疫来预防COVID-19的讨论和新闻报道。这些都是在临床试验中考虑和评估的合理问题。然而，目前，建议改变FDA已经批准的这些疫苗的剂量或时间表是不成熟并且也没有充分根据现有的证据。如果没有适当的在疫苗接种变化的数据支撑，我们将面临将公共卫生置于危险境地的重大风险，破坏为保护人口免受COVIN-19伤害而进行的历史性疫苗接种工作。

The available data continue to support the use of two specified doses of each authorized vaccine at specified intervals. For the Pfizer-BioNTech COVID-19 vaccine, the interval is 21 days between the first and second dose. And for the Moderna COVID-19 vaccine, the interval is 28 days between the first and second dose. 

现有数据继续支撑每隔一定时间使用两种指定剂量核准疫苗。对于辉瑞生物技术COVID-19疫苗，第一剂和第二剂的间隔时间是21天。对于现代的COVID-19疫苗，第一剂和第二剂的间隔时间是28天。

What we have seen is that the data in the firms’ submissions regarding the first dose is commonly being misinterpreted. In the phase 3 trials, 98% of participants in the Pfizer-BioNTech trial and 92% of participants in the Moderna trial received two doses of the vaccine at either a three- or four-week interval, respectively. Those participants who did not receive two vaccine doses at either a three-or four-week interval were generally only followed for a short period of time, such that we cannot conclude anything definitive about the depth or duration of protection after a single dose of vaccine from the single dose percentages reported by the companies.  

我们所看到的是，这些企业递交的关于第一剂的数据通常被误读。在3期临床试验中，无论是间隔3周还是间隔4周，辉瑞98%的受试者和现代92%的受试者各自接种了两剂疫苗。那些没有接种两剂疫苗的受试者无论是间隔3周还是4周通常持续很短一段时间，所以我们无法从这些公司报告的单剂量百分比中得出任何关于单剂疫苗后的保护深度或持续时间的明确结论。

Using a single dose regimen and/or administering less than the dose studied in the clinical trials without understanding the nature of the depth and duration of protection that it provides is concerning, as there is some indication that the depth of the immune response is associated with the duration of protection provided. If people do not truly know how protective a vaccine is, there is the potential for harm because they may assume that they are fully protected when they are not, and accordingly, alter their behavior to take unnecessary risks.

在临床试验中，使用单剂量方案和/或减少剂量接种试验没有理解自然保护提供的有关深度和持续时间，因为有迹象表明，免疫反应的深度与所提供保护的持续时间相关。如果人们不了解疫苗保护的真正作用，就有可能造成伤害，因为它们可能认为自己已经得到了充分的保护，而实际上并没有，因此，它们会改变自己的行为，冒不必要的风险。

We know that some of these discussions about changing the dosing schedule or dose are based on a belief that changing the dose or dosing schedule can help get more vaccine to the public faster. However, making such changes that are not supported by adequate scientific evidence may ultimately be counterproductive to public health.

我们知道一些关于改变剂量时间表或剂量的讨论是基于这样一种信念，即改变剂量或剂量时间表可以使得更多的疫苗更快地提供给公众。然而，没有充分的科学证据支持的这些改变最终可能会对公共健康产生反作用。

We have committed time and time again to make decisions based on data and science. Until vaccine manufacturers have data and science supporting a change, we continue to strongly recommend that health care providers follow the FDA-authorized dosing schedule for each COVID-19 vaccine. 

我们一次又一次地承诺基于数据和科学做出决策。我们继续强烈建议卫生保健提供商遵循FDA授权的每种COVID-19疫苗的给药时间表，直到疫苗制造商拥有支持改变的数据和科学。

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

FDA是美国卫生与公众服务部下属的一个机构，通过确保人用和兽药、疫苗和其他供人使用的生物制品以及医疗器械的安全性、有效性和安全性来保护公众健康。该机构还负责我国食品供应、化妆品、膳食补充剂、散发电子辐射的产品的安全和保障，以及对烟草产品的监管。