Journal of Vaccine Research 2024, Vol.14, No.3, 135-146 http://medscipublisher.com/index.php/jvr 141 trials. This continuous oversight maintains public trust in vaccination programs and ensures that the benefits of vaccines remain significantly higher than the risks (Pulendran and Ahmed, 2011). Table 1 Overall and adverse event rate of different symptoms of adverse event (AEFI) after DTaP-IPV/Hib vaccination in Guangzhou, China from May 2011 to 2017 (n=376) (Adopted from Li et al., 2020) Reporting year and sex Number of DTaP-IPV/Hib doses distributed All AEFI reports AEFI reports with serious AEFI Sex Total Rate per 100,000 DaP-IPV/ Hib doses distributed Sex Total Rate per 100,000 DaP-IPV/ Hib doses distributed Male Female Male Female Total Male Female Male Female Total 2011 19598 4 1 5 20.4 5.1 25.5 0 0 0 0.0 0.0 0.0 2012 48070 12 5 17 25.0 10.4 35.4 1 0 1 2.1 0.0 2.1 2013 69650 23 14 37 33.0 20.1 53.1 0 3 3 0.0 4.3 4.3 2014 94120 39 25 64 41.4 26.6 68.0 0 0 0 0.0 0.0 0.0 2015 84280 35 31 66 41.5 36.8 78.3 0 0 0 0.0 0.0 0.0 2016 100112 76 54 130 75.9 53.9 129.9 2 0 2 2.0 0.0 2.0 2017 100328 39 18 57 38.9 17.9 56.8 2 0 2 2.0 0.0 2.0 Total 516158 228 148 376 44.2 28.7 72.8 5 3 8 1.0 0.6 1.5 Note: This displays the overall and specific adverse event rates of different symptoms of adverse events (AEFI) after DTaP-IPV/Hib vaccination in Guangzhou, China from 2011 to 2017. The data shows that out of 516,000 doses of the vaccine administered, there were 376 reported adverse events (AEFI), with a reporting rate of 72.8 per 100,000 doses. Minor adverse reactions such as fever, redness and swelling at the injection site, and induration were more common, while the rate of severe adverse events was low, accounting for only 2.1%. The incidence of fever after vaccination decreased progressively, from 48.1% after the first dose to 28.0% after the fourth dose, with most cases being Grade I and II fever, and only two cases of severe fever (≥38.6 ℃) (Adapted from Li et al., 2020) 6.4 Strategies for monitoring and mitigating adverse effects To ensure the continued safety of the five-in-one vaccine, robust monitoring and mitigation strategies are essential. These include active surveillance systems that track and analyze adverse events following immunization (AEFI). National AEFI surveillance systems collect data on vaccine-related adverse events, allowing for the identification and investigation of potential safety concerns. Health professionals are trained to recognize and report adverse events, ensuring timely detection and response to any safety signals (Pulendran and Ahmed, 2011). Mitigation strategies also involve educating healthcare providers and the public about the benefits and risks of vaccination. Clear communication about the expected side effects and the importance of completing the vaccination schedule helps maintain public confidence in immunization programs. Research into vaccine formulations and adjuvants continues to improve the safety profiles of vaccines, reducing the risk of adverse effects while maintaining immunogenicity. 7 Regulatory and Ethical Considerations 7.1 Regulatory framework The development and approval of vaccines are governed by stringent regulatory frameworks designed to ensure their safety, efficacy, and quality. These frameworks vary by country but generally include several key stages: preclinical testing, clinical trials (phases I-III), and post-marketing surveillance.
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