FDA的疫苗實驗程序

How a new vaccine is developed, approved and manufactured    FDA

The Food and Drug Administration (FDA) sets rules for the three phases of clinical trials to ensure the safety of the volunteers. Researchers test vaccines with adults first.

Phase 1
20-100 healthy volunteers—20-100位健康志願者

• Is this vaccine safe?—安全性
• Does this vaccine seem to work?—機轉
• Are there any serious side effects?—嚴重副作用
• How is the size of the dose related to side effects?—劑量與副作用的關係

Phase 2
several hundred volunteers—數百位健康志願者

• What are the most common short-term side effects?—短期副作用數
• How are the volunteers’ immune systems responding to the vaccine?—對疫苗之免疫反應

Phase 3
hundreds or thousands of volunteers—數百到數千位志願者

• How do people who get the vaccine and people who do not get the vaccine compare?—兩組對照
• Is the vaccine safe?—安全性
• Is the vaccine effective?—有效性
• What are the most common side effects?—常見副作用

FDA licenses a vaccine only if:FDA核發（最低）標準

• It’s safe and effective—安全與有效性
• Benefits outweigh risks—利大於弊

The FDA inspects manufacturing facilities regularly to ensure safety and quality.

For more information, visit https://www.fda.gov/cberexternal icon