Reference: Law, B. (2020). Priority List of COVID-19 Adverse events of special interest: Quarterly update December 2020. Safety Platform for Emergency Vaccines. Summary: The report updates the list of adverse events of special interest AESI) associated with COVID-19 vaccines, generated by the Safety Platform for Emergency Vaccines (SPEAC) Project. The quarterly review focuses on new […]
Reference: U.S. Food and Drug Administration. (2020). Vaccines and related biological products advisory committee meeting December 10, 2020 FDA briefing document Pfizer-BioNTech COVID-19 vaccine. https://www.fda.gov/media/144246/download Summary: On December 10, 2020, the Vaccines and Related Biological Products Advisory Committee (VRBPAC) reviewed Pfizer-BioNTech’s COVID-19 vaccine, BNT162b2, which received an Emergency Use Authorization (EUA) request on November 20,
Reference: Joi, P. (2020). What is the difference between efficacy and effectiveness? Gavi, the Vaccine Alliance. Retrieved from https://www.gavi.org/vaccineswork/what-difference-between-efficacy-and-effectiveness Summary: Efficacy and effectiveness are two crucial terms in vaccine science, often conflated but distinct. Efficacy refers to the performance of a vaccine under ideal, controlled conditions, typically demonstrated in clinical trials where a vaccinated group
Reference: Anderson, S. (2020). CBER plans for monitoring COVID-19 vaccine safety and effectiveness. Vaccines and Related Biological Products Advisory Committee Meeting, FDA. Summary: The FDA’s Centre for Biologics Evaluation and Research (CBER) presented its comprehensive strategy for monitoring the safety and effectiveness of COVID-19 vaccines during the VRBPAC meeting on October 22, 2020. The approach
Reference: U.S. Department of Health and Human Services. (2020). Contains nonbinding recommendations: Development and licensure of vaccines to prevent COVID-19 guidance for industry. Food and Drug Administration. Summary: In June 2020, the U.S. Food and Drug Administration (FDA) issued guidance to assist the development and licensure of COVID-19 vaccines amidst the public health emergency. This
Reference: Pfizer. (2020). PF-07302048 (BNT162 RNA-Based COVID-19 vaccines) protocol C4591001. Summary: The document outlines the Phase 1/2/3 clinical trial to evaluate the safety, tolerability, immunogenicity, and efficacy of BNT162 RNA-based COVID-19 vaccines, developed by Pfizer and BioNTech. The trial investigates two vaccine candidates: BNT162b1, encoding the receptor-binding domain (RBD), and BNT162b2, encoding the prefusion spike
Reference: Singh, K., & Mehta, S. (2016). The clinical development process for a novel preventive vaccine: An overview. Journal of Postgraduate Medicine, 62(1), 4–11. https://doi.org/10.4103/0022-3859.173187 Summary: The article provides a comprehensive overview of the clinical development process for novel preventive vaccines, detailing the essential phases of vaccine trials: Phase I, II, and III. It highlights
Reference: Smedman, L., Joki, A., da Silva, A. P., Troye-Blomberg, M., Aronsson, B., & Perlmann, P. (1994). Immunosuppression after measles vaccination. Acta Paediatrica, 83(2), 164-168. https://doi.org/10.1111/j.1651-2227.1994.tb13043.x Summary: The study investigates the effects of live attenuated measles vaccination on cellular immune responses in children from Sweden and Guinea-Bissau. Sixteen children from each region were assessed before