Reference: Thomas, S. J., Moreira, E. D. Jr., Kitchin, N., et al. (2021). Safety and efficacy of the BNT162b2 mRNA Covid-19 vaccine through 6 months. New England Journal of Medicine, 385, 1761-73. https://doi.org/10.1056/NEJMoa2110345 Summary: This supplementary appendix provides detailed data related to the safety and efficacy of the BNT162b2 mRNA COVID-19 vaccine, as explored in […]
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: 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
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
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.
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
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