Analysis of the factors that influence vaccine safety
- Vaccine regulations
Over the past years, formal regulations of the vaccine have been a critical factor that has led to increased safety of vaccinations. In the United States, policymakers have been making policies to regulate the range of the functions covering the whole continuum of developing, selling, and using vaccines (WHO, 2013). Therefore, due to the increased progress of strict vaccine regulations and well-defined procedures across the globe have led to increased transparency of the vaccine developing organization. Besides, increased surveillance has played a critical role in forcing developing organizations to rely on good manufacturing practices and impact surveillance, thereby resulting in increased vaccine safety.
- Pre-licensure surveillance requirements
As vaccines undergo comprehensive testing and evaluation for safety, pre-licensure clinical trials have been critical in monitoring the adverse reactions. During the clinical trials and review for vaccine safety, a vaccine must undergo three clinical trial phases. The first clinical trial involves testing the safety and immunogenicity to determine the tolerability of the vaccine among low-risk individuals (Singh & Mehta, 2016). Following complete testing, the immune response, possible adverse effects, and the optimal dosage is determined. In phase three, the clinical efficacy of the vaccine is tested across heterogeneous populations (WHO, 2013). Based on the pre-licensure safety consideration, a continuous identification of the acute adverse effects of a vaccine is made, thereby resulting in safer vaccination. However, rare adverse effects and those with deferred arrival are rarely detected.
- Post-licensure surveillance requirements
Post-licensure surveillance requirements have a critical role in guaranteeing the safety of the vaccine. Typically, post-licensure surveillance takes place when the vaccine is available in a real-world setting; hence, its recipients are no longer in the clinical trials (Lopalco & DeStefano, 2015). This means that subpopulations that might be excluded in the clinical trials—such as those with underlying medical conditions—are also getting the vaccination. Due to the need for increased surveillance to capture efficacy and potential effects of the vaccine, spontaneous reporting is inherently inevitable because it helps in capturing unexpected events (WHO, 2013). Therefore, since the vaccine developers have to increase surveillance in monitoring the safety of the vaccination post-licensure, there has been a drastic increase in vaccine safety. Generally, as the surveillance for vaccine increases, the potential vaccine-related risks have been identified and immediately modified to increase the vaccine efficacy.
References
Lopalco, P. L., & DeStefano, F. (2015). The complementary roles of Phase 3 trials and post-licensure surveillance in the evaluation of new vaccines. Vaccine, 33(13), 1541-1548.
Singh, K., & Mehta, S. (2016). The clinical development process for a novel preventive vaccine: An overview. Journal of postgraduate medicine, 62(1), 4.
World Health Organization. (2013). Vaccine safety basics-learning manual. Geneva: WHO. Available at; https://www.who.int/vaccine_safety/initiative/tech_support/Vaccine-safety-E-course-manual.pdf