Reference: Liu, J., Wang, J., Xu, J., Xia, H., Wang, Y., Zhang, C., Chen, W., Zhang, H., Liu, Q., Zhu, R., Shi, Y., Shen, Z., Xing, Z., Gao, W., Zhou, L., Shao, J., Shi, J., Yang, X., Deng, Y., Wu, L., Lin, Q., Zheng, C., Zhu, W., Wang, C., Sun, Y. E., & Liu, Z. […]
Reference: Bruno, R., McCullough, P., et al. (2021). 157 Top Scientists and Doctors Release Shocking Study on COVID Vaccines and Demand Immediate Stop to All Vaccinations. Global Research. Summary: A report by 57 prominent scientists and doctors has raised significant concerns about the safety and efficacy of COVID-19 vaccines, urging an immediate cessation of vaccination
Reference: Informed Consent Action Network. (2022). V-safe data. https://icandecide.org/v-safe-data/#v-safe-downloads Summary: The V-Safe Data report from the Informed Consent Action Network (ICAN) presents comprehensive statistics on adverse health impacts following COVID-19 vaccinations. The data indicates that over 10 million individuals registered on the V-Safe platform, with significant health impacts reported, totalling approximately 6.4 million. The report
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: National Institutes of Health. (2020, July 27). Phase 3 clinical trial of investigational vaccine for COVID-19 begins. https://www.nih.gov/news-events/news-releases/phase-3-clinical-trial-investigational-vaccine-covid-19-begins Summary: The National Institutes of Health (NIH) has commenced a Phase 3 clinical trial to assess the efficacy of the investigational mRNA-1273 vaccine, co-developed by Moderna, Inc. and NIH’s National Institute of Allergy and Infectious Diseases
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