Fact Check: Vaccines must prove they do not negatively affect safety or immune response before FDA licensure.

Fact Check: "Vaccines must prove they do not negatively affect safety or immune response before FDA licensure."

What We Know

Vaccines undergo a rigorous development and approval process regulated by the U.S. Food and Drug Administration (FDA). This process is designed to ensure that vaccines are both safe and effective before they can be licensed for public use. According to the CDC, the vaccine development process includes several stages: research and discovery, proof of concept, testing, manufacturing, approval, and post-licensure monitoring (CDC).

During the clinical trial phases, particularly Phase 1 and Phase 2, researchers assess the vaccine's safety and its ability to elicit an immune response. Phase 1 trials involve small groups of participants (20 to 100), while Phase 2 expands this to hundreds (100-300) of participants. It is during these phases that data on side effects and immune response is collected (CDC).

Before a vaccine can be approved, the manufacturer must submit a Biological License Application (BLA), which includes pre-clinical and clinical data demonstrating the vaccine's safety and effectiveness (CDC). The FDA reviews this data to determine whether the vaccine meets the necessary safety and efficacy standards.

Analysis

The claim that "vaccines must prove they do not negatively affect safety or immune response before FDA licensure" is supported by the established protocols for vaccine approval. The FDA requires comprehensive data on safety and efficacy during the clinical trial phases. Specifically, the pre-licensure safety database for preventive vaccines must demonstrate that the vaccine does not have adverse effects on safety or immune response (FDA).

Moreover, the FDA's guidance for vaccine development emphasizes the importance of evaluating the immune response generated by the vaccine, which is critical for its approval (FDA). The rigorous nature of this process is further highlighted by the fact that it can take years for a vaccine to be licensed, as seen with the varicella vaccine, which took approximately 11 years (Children's Hospital of Philadelphia).

While there are alternative pathways for vaccine approval, such as Emergency Use Authorization (EUA), these do not apply to standard licensure processes and are subject to different criteria (CDC). Thus, the claim holds true within the context of the FDA's standard licensure process.

Conclusion

Verdict: True
The statement that "vaccines must prove they do not negatively affect safety or immune response before FDA licensure" is accurate. The FDA's stringent requirements for vaccine approval necessitate comprehensive evidence demonstrating both safety and efficacy, which includes the assessment of immune response and potential adverse effects.

Sources

1. How Vaccines are Developed and Approved for Use
2. PDF ACIP-June, 2020 Considerations for FDA Licensure vs. Emergency Use ...
3. Vaccine and Related Biological Product Guidances | FDA
4. Emergency Use Authorization for Vaccines to Prevent COVID-19 Guidance ...
5. Vaccine Science: Licensure, Recommendations and Requirements
6. Development, Authorization & Licensure of Vaccines to Prevent COVID-19