News & Insights
Human Challenge Studies for Vaccine Development: Regulatory Aspects of Human Challenge Studies
Introduction The traditional regulatory pathway for the evaluation of new vaccine candidates generally proceeds from preclinical through three successive phases of human trials. Study phases may overlap, and the clinical testing may be highly iterative because multiple Phase 1 or 2 trials may need to…
Vaccine Supply: Shortages and Challenges
https://khn.org/news/article/after-billions-of-dollars-and-dozens-of-wartime-declarations-why-are-vaccines-still-in-short-supply/ The article linked to above provides an excellent overview of the status and rollout of US COVID-19 vaccines and explains some of the technical and organizational challenges…
Concern of blood clot issues with the AstraZeneca and J&J vaccines
https://news.yahoo.com/clear-between-astrazeneca-vaccine-rare-115707510.html https://www.fda.gov/news-events/press-announcements/joint-cdc-and-fda-statement-johnson-johnson-covid-19-vaccine https://www.healthline.com/health-news/johnson-johnson-covid-19-vaccine-side-effects-what-to-knowThe articles…
AstraZeneca’s Trial Is on Hold. It’s a Sign that the Science Is Working
Everyone awaiting a vaccine against Covid-19 must understand this fact: Bad outcomes may happen in vaccine trials. The good news is the U.S. Food and Drug Administration evaluates these outcomes before approving a vaccine. The purpose of clinical trials is to discover what can go wrong with a vaccine…
FDA issues COVID-19 Vaccine Guidance
On June 30, 2020 FDA issued a new guidance on Development and Licensure of Vaccines to Prevent COVID-19. The guidance sets regulatory expectations for the manufacture, non-clinical, clinical and post-licensure use of the vaccine(s). While the agency is cognizant of the urgent need for a COVID-19 vaccine…
Antibody-Dependent Enhancement Risk for SARS-CoV-2 Vaccine Developers
This article explores a phenomenon called Antibody-Dependent Enhancement (ADE). This occurs when binding of a virus to non-neutralizing antibodies enhances its entry into host cells, and sometimes also its replication. The clinical outcome in individuals where an immune response results in the production…