How a New Vaccine Is Developed, Approved and Manufactured一种新疫苗是如何研发、批准和生产的？

Food and Drug Administrationsets rules for the three phases of clinical trials to ensure the safety of the volunteers.

 FDA对三个阶段的临床试验制定规则以保证志愿者的安全，试验疫苗的首先在成人中进行试验。

Phase 1

Researchers test vaccines with adults first. Between 20-100 healthy volunteers receive the test vaccine. Researchers study to determine:

• 此疫苗是否安全？Is this vaccine safe?
• 此疫苗是否可能有效？Does this vaccine seem to work?
• 是否有严重不良反应？Are there any serious side effects?
• 剂量与不良反应的相关性如何？How is the size of the dose related to side effects?

Phase 2

Several hundred additional, healthy volunteers receive a test vaccine and researchers determine:

• 较多的一般性短期不良反应是什么？What are the most common short-term side effects?
• 志愿者对此疫苗的免疫反应怎样？How are the volunteers’ immune systems responding to the vaccine?

Phase 3

Hundreds or thousands of volunteers participate in the Phase 3 test, after which researchers determine:

• 接种疫苗与不接种疫苗人群比较结果？How do people who get the vaccine and people who do not get the vaccine compare?
• 此疫苗是否安全？Is the vaccine safe?
• 此疫苗是否有效？Is the vaccine effective?
• 常见的不良反应有哪些？What are the most common side effects?

FDA licenses a vaccine only if FDA批准新疫苗的条件:

• 安全并且有效It’s safe and effective
• 接种效益大于其风险性Benefits outweigh risks

Vaccines are made in batches called lots.

生产企业对所有批次产品进行全面检测以保证其安全有效，FDA审核期安全和质量实施批签发放行。Manufacturers must test all lots to make sure they are safe, pure and potent. The lots can only be released once FDA reviews their safety and quality.

FDA对生产企业的生产设施等进行检查以保证安全和质量。

The FDA inspects manufacturing facilities regularly to ensure safety and quality.For more information, visit http://www.fda.gov/cberIf the FDA licenses a vaccine, experts may consider adding it to the recommended immunization schedule

一旦新疫苗被FDA批准，专家会研究考虑把此疫苗添加至推荐的免疫程序中

How a Vaccines Is Added to the U.S. Recommended Immunization Schedule

The Advisory Council on Immunization Practices  is a group of medical and public health experts. Members of the American Academy of Pediatrics (AAP) and American Academy of Family Physicians (AAFP) are among some of the groups that also bring related immunization expertise to the committee. This group carefully reviews all available data about the vaccine from clinical trials and other studies to develop recommendations for vaccine use.When making recommendations, ACIP considers:[Picture of a stethoscope]

美国预防接种谘询委员会(ACIP)由医学和公共卫生专家组成，美国小儿科医学会和美国家庭医师学会的成员同样参与提交相关的免疫经验至委员会。此组织会仔细地回顾疫苗从临床研究以及其他相关研究的数据。

• 当疫苗给特定年龄人接种时安全性如何？How safe is the vaccine when given at specific ages?
• 当一名给特定年龄人接种时其效果如何？How well does the vaccine work at specific ages?
• 此疫苗所预防疾病的严重性如何？How serious is the disease this vaccine prevents?
• 如果不接种，次疫苗所预防疾病的儿童感染率如何？How many children would get the disease the vaccine prevents if we didn’t have the vaccine?

ACIP recommendations are not official until the CDC Director reviews and approves them and they are published. These recommendations then become part of the United States official childhood immunization schedule.直至CDC主管部门对ACIP的建议进行审核并批准公布此推荐建议才有效，随后作为美国官方儿童免疫程序的一部分。New vaccine to protect your child against a disease is added to the schedule.For more information, visit http://www.cdc.gov/vaccinesAfter being added to the U.S. Recommended Immunization Schedule, health experts continue to monitor the vaccine’s safety and effectiveness.

How a Vaccine’s Safety Continues to be Monitored

FDA and CDC closely monitor vaccine safety after the public begins using the vaccine.

监察的目的是否观察不良反应事件（可能的副反应）

The purpose of monitoring is to watch for adverse events (possible side effects).

疫苗被批准后的监察可以帮助鉴定与疫苗相关的可能风险。

Monitoring a vaccine after it is licensed helps ensure that possible risks associated with the vaccine are identified.Vaccine Adverse Event Reporting System (VAERS) 

疫苗不良事件报告系统(VAERS)VAERS收集并分析疫苗接种后发生的不良反应事件报告，包括家长、病人和健康专业人员在内的任何人都可以提交报告。

collects and analyzes reports of adverse events that happen after vaccination. Anyone can submit a report, including parents, patients and healthcare professionals.[Picture of a web of healthcare organizations]: The Vaccine Safety Datalink (VSD) is a network of healthcare organizations across the U.S.[Picture of a document with healthcare information]

所有人通过疫苗安全数据库可获取医疗健康信息

Healthcare information is available through the Vaccine Safety Datalink for a population of over 9 million people.Scientists use VSD to conduct studies to evaluate the safety of vaccines and determine if possible side effects are actually associated with vaccination.

科学家可使用疫苗安全数据库指导研究，评价疫苗的安全性以及判定不良反应是否真的由疫苗本身引起。Vaccine recommendations may change if safety monitoring shows that the vaccine risks outweigh the benefits (like if scientists detect a new serious side effect).

如果安全性监察结果显示此疫苗使用风险高于其效益（比如监察到新的严重不良反应）会更改此疫苗的推荐使用。

For more information, visit http://www.cdc.gov/vaccinesafetyThe United States currently has the safest vaccine supply in its history. These vaccines keep children, families and communities protected from serious diseases.