Fast Tracking-Vaccine Safety, Efficacy, and Lessons Learned: A Narrative Review

(1) Background: The COVID-19 pandemic has led to the fast-tracked development of vaccines under emergency use authorization. In light of the growing concerns about fast-tracked vaccines, this article reviews the safety, efficacy, and lessons learned of previously fast-tracked vaccines. (2) Methods: An article search regarding the safety and efficacy of fast-tracked vaccines was done in PubMed, Embase, Web of Science, and ScienceDirect. Of the 104 results, 24 articles were included. Five articles about BiovaxID, THERATOPE (R), Sipuleucel-T, and AIDSVAX were also reviewed. (3) Results: The overall efficacy was shown to be 77-100%, with seroprotection against the viruses ranging from 87 to 100%. The antibody responses for optimal protection against the viruses fall within 85-97%. Generally, the fast-tracked vaccines were well-tolerated and had few significant adverse events, except for the H1N1 pandemic vaccine and its association with narcolepsy. To have accurate, precise, and timely fast-tracked vaccines, communication, sharing resources/data, and improving the current structures/outbreak operations are crucial. (4) Conclusions: This review found the FDA's fast-tracking process for vaccines to have rigorous standards similar to the normal process. The previous fast-tracked vaccines were safe and efficacious. The lessons drawn from previous studies highlighted the significance of planning and utilizing global resources during significant outbreaks.

Automated summary

This article reviews the safety, efficacy, and lessons learned from previously fast-tracked vaccines and finds that they are generally safe and effective. Effective communication, resource sharing, and improving outbreak response structures are important for timely fast-tracked vaccine development.