Vaccine Developers and Scientists Call for More Investment and Better Technology in Vaccine Post-Licensing Safety Monitoring

The monitoring for safety of a vaccine does not stop once the vaccine is approved for use in the United States. There is what is called “post-authorization safety monitoring,” which, as the name implies, is monitoring after authorization; and different private and public entities carry out the monitoring. In , Daniel A. Salmon, Ph.D., M.P.H., Walter A. Orenstein, M.D., Stanley A. Plotkin, M.D., and Robert T. Chen, M.D., write about the need for better funding of post-authorization vaccine safety science. The authors write about how the limitations of pre-licensure safety studies can be overcome if proper funding existed for post-licensure studies.

However, the problem is not a lack of safety monitoring once a vaccine is approved for use. The problem is that the systems in place have become stagnant and don’t live up to the potential of modern science. Here’s a rundown of the opinion piece:

• The authors emphasize the need for comprehensive postauthorization studies to fully understand the safety profile of new vaccines. Prelicensure clinical trials often have limitations, such as small sample sizes, short follow-up durations, and lack of population diversity.
• Existing systems like the Vaccine Adverse Event Reporting System (VAERS) have limitations. VAERS is a passive surveillance system that relies on voluntary reporting and often lacks detailed clinical and laboratory information, making it difficult to establish causality for adverse events.
• The budget for vaccine safety monitoring has been stagnant for decades, significantly affecting the ability to conduct timely and comprehensive safety studies. The authors propose amending the Vaccine Injury Compensation Program (VICP) tax code to allocate funds specifically for vaccine safety research, ensuring adequate and timely funding linked to the introduction of new vaccines.
• Slow progress in vaccine safety science has contributed to public distrust and vaccine hesitancy. The authors argue that better-funded and more rigorous vaccine safety research can help rebuild public confidence in immunization programs.
• The authors suggest using a portion of the existing VICP Trust Fund to support vaccine safety research. This would include epidemiologic studies, genomic investigations, and other research to understand the biologic mechanisms of adverse reactions. They also recommend an independent review of the vaccine safety system to optimize its structure and governance.
• The piece also highlights the need for legislative action to ensure that vaccine safety monitoring and research are adequately funded and prioritized, reflecting the original intent of the VICP to improve vaccine safety and prevent injuries.

Almost on cue, the anti-vaccine activists in the United States . A quick reading of the article shows this is not the case, but most readers of the social media postings of those activists won’t have access to the article. The article is behind a paywall for the New England Journal of Medicine. Even if it was freely and widely available, there is good evidence that people who believe in anti-vaccine conspiracy theories would rather believe in those lies than read and/or understand the evidence for themselves.

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