Journal of Vaccine Research 2024, Vol.14, No.5, 269-277 http://medscipublisher.com/index.php/jvr 273 Agency (EMA) implemented emergency use authorizations (EUAs) to expedite the approval of vaccines such as Pfizer-BioNTech's BNT162b2 and Moderna's mRNA-1273 (Hafner et al., 2020). These accelerated pathways were based on the immediate need for pandemic control, coupled with robust Phase 3 clinical trial data demonstrating vaccine efficacy and safety (Chen, 2024). While these processes were crucial in addressing the global health emergency, they raised concerns regarding the potential trade-offs between speed and thorough evaluation of long-term effects (Tanne, 2020). As more vaccines come to market for various diseases, ensuring that expedited approval pathways maintain high standards of safety and efficacy remains a key challenge for regulatory bodies. Figure 1 Nanoparticle platform vaccine technologies (Adopted from Shin et al., 2021) Image caption: a: Protein nanoparticles and their size; sizes for the synthetic nanocarriers vary between 10~1 000 nm. The protein nanoparticles were prepared using Chimera software using the PDB files (3IYI, 1FHA, 1NY7 for P22, ferritin and CPMV, respectively). b: Components of nanoparticle-based vaccines. C: Key steps involved in nanoparticles-based vaccine processing by APCs. The antigenic cargo is processed by the APC and epitopes are presented by MHC-I and MHC-II leading to production of CD8+ cytotoxic T cells or CD4+ T helper cells required for antiviral antibody production (or a combination thereof) (Adopted from Shin et al., 2021) 6.2 Safety monitoring and long-term effects With the rapid deployment of mRNA vaccines, comprehensive post-market safety monitoring has become essential to detect rare or long-term adverse events. Regulatory agencies and manufacturers have implemented large-scale pharmacovigilance systems, such as the Vaccine Adverse Event Reporting System (VAERS) in the U.S. and the EudraVigilance database in the EU, to track and analyze vaccine safety in real-world populations (Moon et al., 2021). Early data have demonstrated the general safety of mRNA vaccines, but rare side effects such as myocarditis in young males have been observed (Mevorach et al., 2021). Long-term monitoring is critical to understanding the full safety profile of these vaccines, including potential impacts on immunity, autoimmune diseases, or other health conditions that may only emerge years after vaccination. Ongoing studies aim to assess these long-term effects, and the integration of advanced data analytics will help regulatory authorities ensure public safety while promoting trust in the vaccines (Polack et al., 2020).
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