Before a new vaccine is approved for release on the market, a rigorous regulatory procedure to assess these steps should be undertaken:

Question

Before a new vaccine is approved for release on the market, a rigorous regulatory procedure to assess these steps should be undertaken:

BlackTom AI · Accepted Answer

Question restatement: Before a new vaccine is approved for release on the market, a rigorous regulatory procedure to assess these steps should be undertaken:

Answer options: 
- Safety.
- Efficacy.
- Quality
- All of the above.

Option 1: 'Safety.' Regulatory review certainly includes safety assessment to ensure the vaccine does not pose unacceptable risks to recipients, evaluating adverse events, reactogenicity, and overall risk/benefit balance. However, focusing only on safety omits other essential dimensions that regulators consider.

Option 2: 'Efficacy.' Demonstrating that the vaccine provides the intended protective effect under defined conditions is crucial. Efficacy data from well-designed trials inform whether the vaccine actually prevents disease in the target population. Yet, efficacy assessment alone does not address how the product is manufactured or whether the benefits outweigh potential harms.

Option 3: 'Quality.' Quality assessment covers the manufacturing process, product consistency, stability, and purity. This ensures the vaccine is produced to predefined specifications and remains safe and effective throughout its shelf life. Nevertheless, quality alone does not guarantee safety or efficacy in humans if the product is not proven to work or if there are material risks.

Option 4: 'All of the above.' When considering a new vaccine, regulators examine safety, efficacy, and quality collectively. The regulatory approval process integrates all three domains to ensure a vaccine is safe, effective, and manufactured to high quality standards before it reaches the market.

Rationale for why each choice may be considered insufficient on its own: Safety alone cannot confirm that the vaccine prevents disease or that the manufacturing process yields a reliable product. Efficacy without assurance of consistent quality could lead to variable or unethical outcomes. Quality without evidence of regulatory safety and efficacy would not provide a complete guarantee for public health. Thus, the most comprehensive and accurate choice reflects the integrated regulatory assessment across all three areas.

In sum, the statement that encompasses all essential regulatory considerations—safety, efficacy, and quality—best captures the rigorous evaluation performed before vaccine approval, illustrating why a combined approach is required in regulatory review.

RGA6221.21827.202525 Quiz # 6 is Due March 29th by 11:59PM EST

Before a new vaccine is approved for release on the market, a rigorous regulatory procedure to assess these steps should be undertaken:

查看解析

登录即可查看完整答案

类似问题

Question at position 52 When the FDA considers a new vaccine for approval their two main concerns are…Safety and efficacyFast approval and costProfit and lossNone of the aboveClear my selection

In a consumer society, many adults channel creativity into buying things

Economic stress and unpredictable times have resulted in a booming industry for self-help products

People born without creativity never can develop it

A product has a selling price of $20, a contribution margin ratio of 40% and fixed cost of $120,000. To make a profit of $30,000. The number of units that must be sold is: Type the number without $ and a comma. Eg: 20000

Which of the following statement regarding cost is correct:

Under the assumptions used in cost-volume-profit analysis, as the activity increases:

The CVP and break-even analysis are supported by a range of important assumptions. Which of the following is not an assumption of the CVP:

更多留学生实用工具

考试浏览器助手

风格化写作助手

论文查重助手

文献引用助手

课堂转译助手

课堂笔记助手

Quiz搜索助手

学校历年真题

智能刷题助手

智能匹配练习

希望你的学习变得更简单