News & Insights
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…
COVID-19 Vaccine Cold Chain Management Compliance Considerations
With the advent of Coronavirus (COVID-19) disease as a public health emergency, and the development of novel vaccine candidates, addressing the challenges of cold chain management for storage and distribution will be critical. While vaccines typically require similar transport and storage controls, some…
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…
Pre-IND Meeting Requests for COVID-19 Products
Given the numerous inquiries from prospective sponsors interested in conducting clinical trials for COVID-19 products, FDA has issued new guidance to assist sponsors in preparing Type B pre-investigational new drug application (pre-IND) meeting requests for COVID-19 related drugs and biologics1. This…
CGMP Compliance Challenges with COVID-19 Infection
With the advent of Coronavirus (COVID-19) disease as a public health emergency, FDA has issued new guidance on COVID-19 infection in employees [Good Manufacturing Practice Considerations for Responding to COVID-19 Infection in Employees in Drug and Biological Products Manufacturing/ Guidance for Industry…