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[quote=Anonymous]Must all vaccines go through the above process?

Yes, all vaccines intended for use in the United States must go through a rigorous FDA process to ensure safety, efficacy, and quality. However, there are some variations depending on the situation:

1. Standard Approval Process

•	Most vaccines go through the full process, including preclinical research, clinical trials (Phases 1–3), and FDA review.
	•	This applies to vaccines developed for non-urgent public health needs.

2. Emergency Use Authorization (EUA)

•	In public health emergencies (e.g., pandemics), the FDA may grant an EUA to allow temporary use of a vaccine before full approval.
	•	To receive an EUA, vaccine developers must provide substantial evidence from clinical trials showing that the vaccine is likely effective and that its benefits outweigh potential risks.
	•	Even under an EUA, vaccines must undergo preclinical studies, clinical trials, and FDA review of safety and efficacy data.

3. Accelerated or Priority Review

•	The FDA can expedite the review process for vaccines addressing critical public health issues (e.g., fast-tracking or priority review).
	•	This doesn’t skip steps but speeds up the timeline by allocating more resources to the review process.

4. Exceptions for Existing Platforms

•	Vaccines based on well-studied platforms (e.g., those using technologies already approved for other vaccines) may require fewer initial studies, as long as the safety and efficacy of the platform are well-documented.
	•	Even in these cases, clinical trials and a thorough review are still mandatory.

5. Post-Market Requirements

•	For all vaccines, post-market surveillance is essential, whether the vaccine is fully approved or authorized under an EUA. The FDA requires continued data collection to monitor long-term safety and effectiveness.

No vaccine can bypass the core requirements for ensuring safety and efficacy, though the timeline and specific steps may be adjusted in emergencies or for certain situations.[/quote]

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