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COVID-19, Covid-19 vaccines, Other scientific evidence, Resource Type, Vaccine risk benefit analysis, Vaccine safety & adverse events, Vaccines, Viral illnesses

Understanding Efficacy and Effectiveness of Vaccines

| | COVID-19, Covid-19 vaccines, Other scientific evidence, Resource Type, Vaccine risk benefit analysis, Vaccine safety & adverse events, Vaccines, Viral illnesses

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 […]

COVID-19, Covid-19 vaccines, Other scientific evidence, Resource Type, Vaccine safety & adverse events, Vaccines, Viral illnesses

Monitoring COVID-19 Vaccine Safety: FDA’s Comprehensive Plan

| | COVID-19, Covid-19 vaccines, Other scientific evidence, Resource Type, Vaccine safety & adverse events, Vaccines, Viral illnesses

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

COVID-19, Covid-19 vaccines, Other scientific evidence, Resource Type, Vaccine effectiveness, Vaccines, Viral illnesses

Phase 3 Clinical Trial of COVID-19 Vaccine Initiated

| | COVID-19, Covid-19 vaccines, Other scientific evidence, Resource Type, Vaccine effectiveness, Vaccines, Viral illnesses

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

COVID-19, Covid-19 vaccines, Ethics, Reference Library, Vaccine effectiveness, Vaccine safety & adverse events, Vaccines, Viral illnesses

Guidance on COVID-19 Vaccine Development

| | COVID-19, Covid-19 vaccines, Ethics, Reference Library, Vaccine effectiveness, Vaccine safety & adverse events, Vaccines, Viral illnesses

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

COVID-19, Covid-19 vaccines, Epidemiological surveillance, Other scientific evidence, Resource Type, Statistical evidence, Vaccine effectiveness, Vaccine safety & adverse events, Vaccines, Viral illnesses

Safety and Efficacy of BNT162 RNA-Based COVID-19 Vaccines

| | COVID-19, Covid-19 vaccines, Epidemiological surveillance, Other scientific evidence, Resource Type, Statistical evidence, Vaccine effectiveness, Vaccine safety & adverse events, Vaccines, Viral illnesses

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

Genetic vaccines, Other viral illnesses, Peer-reviewed evidence, Resource Type, Vaccine effectiveness, Vaccines, Viral illnesses

The Evolution of mRNA Vaccines

| | Genetic vaccines, Other viral illnesses, Peer-reviewed evidence, Resource Type, Vaccine effectiveness, Vaccines, Viral illnesses

Reference: Pardi, N., Hogan, M. J., Porter, F. W., & Weissman, D. (2018). mRNA vaccines — a new era in vaccinology. Nature Reviews Drug Discovery, 17(4), 261-279. https://doi.org/10.1038/nrd.2017.243 Summary: mRNA vaccines offer a potent alternative to traditional vaccine approaches due to their rapid development and cost-effective manufacturing. They have shown promise in preventing infectious diseases

Genetic vaccines, Other viral illnesses, Peer-reviewed evidence, Resource Type, Vaccine effectiveness, Vaccines, Viral illnesses

Immunogenicity of mRNA Vaccines for Influenza Viruses

| | Genetic vaccines, Other viral illnesses, Peer-reviewed evidence, Resource Type, Vaccine effectiveness, Vaccines, Viral illnesses

Reference: Bahl, K., Senn, J. J., Yuzhakov, O., Bulychev, A., Brito, L. A., Hassett, K. J., Laska, M. E., Smith, M., Almarsson, Ö., Thompson, J., Ribeiro, A. (Mick), Watson, M., Zaks, T., & Ciaramella, G. (2017). Preclinical and clinical demonstration of immunogenicity by mRNA vaccines against H10N8 and H7N9 influenza viruses. Molecular Therapy, 25(6), 1316-1326.

Antigenic vaccines, General Health, Immunology, Other viral illnesses, Peer-reviewed evidence, Reference Library, Resource Type, Vaccine effectiveness, Vaccines, Viral illnesses

Dendritic Cell Immunotherapy for HIV-1: A Phase IIB Trial

| | Antigenic vaccines, General Health, Immunology, Other viral illnesses, Peer-reviewed evidence, Reference Library, Resource Type, Vaccine effectiveness, Vaccines, Viral illnesses

Reference: Jacobson, J. M., Routy, J.-P., Welles, S., DeBenedette, M., Tcherepanova, I., Angel, J. B., Asmuth, D. M., Stein, D. K., Baril, J.-G., McKellar, M., Margolis, D. M., Trottier, B., Wood, K., & Nicolette, C. (2016). Dendritic cell immunotherapy for HIV-1 infection using autologous HIV-1 RNA: A randomized, double-blind, placebo-controlled clinical trial. Journal of Acquired

Antigenic vaccines, General Health, Immunology, Other viral illnesses, Peer-reviewed evidence, Reference Library, Resource Type, Vaccines, Viral illnesses

Immunization of HIV-1-Infected Persons with Dendritic Cells

| | Antigenic vaccines, General Health, Immunology, Other viral illnesses, Peer-reviewed evidence, Reference Library, Resource Type, Vaccines, Viral illnesses

Reference: Gandhi, R. T., Kwon, D. S., Macklin, E. A., Shopis, J. R., McLean, A. P., McBrine, N., Flynn, T., Peter, L., Sbrolla, A., Kaufmann, D. E., Porichis, F., Walker, B. D., Bhardwaj, N., Barouch, D. H., & Kavanagh, D. G. (2016). Immunization of HIV-1-Infected Persons With Autologous Dendritic Cells Transfected With mRNA Encoding HIV-1

Other viral illnesses, Peer-reviewed evidence, Resource Type, Vaccine effectiveness, Vaccine safety & adverse events, Vaccines, Viral illnesses

Overview of Clinical Development for Vaccines

| | Other viral illnesses, Peer-reviewed evidence, Resource Type, Vaccine effectiveness, Vaccine safety & adverse events, Vaccines, Viral illnesses

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

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