Funding for Phase Four Vaccine Studies Needed

While many people have recently learned about the clinical trial research process, most are unaware these studies are conducted according to a plan containing an essential fourth type of study: phase four.

These late-stage studies, often called post-marketing research, are conducted after the U.S. FDA has approved a vaccine or medication.

Clinical research leaders wrote a comprehensive Perspective, suggesting an innovative method for increasing the number of phase four studies.

The New England Journal of Medicine published the article VOL on July 6, 2024. 391 NO. 2—Funding Postauthorization Vaccine-Safety Science, which wrote, 'the United States benefits from a robust federal immunization program that has been successful in controlling and eliminating many diseases.

However, the widespread vaccine hesitancy observed during the recent pandemic suggests that the public is no longer satisfied with the traditional safety goal of simply detecting and quantifying the associated risks after a vaccine has been authorized.

The authors continued that post-authorization studies are needed to fully characterize the safety profile of a new vaccine since prelicensure clinical trials have limited sample sizes, follow-up durations, and population heterogeneity.

Post-authorization vaccine safety research requires adequate and timely funding directly linked to introducing new vaccines.

However, the U.S. CDC's vaccine safety monitoring budget has remained stagnant at about $20 million per year.

Although these resources have been used efficiently, this inadequate level of funding has adversely affected the speed and completeness of the science.

The unedited, complete Perspective is posted at this NEJM link.

These authors did not disclose industry conflicts of interest and were from the Institute for Vaccine Safety, Johns Hopkins Bloomberg School of Public Health, Baltimore; Emory University, Atlanta; the University of Pennsylvania, Philadelphia; and the Brighton Collaboration, Task Force for Global Health, Decatur, GA.