The Science is There: Key Considerations for Stabilizing Viral Vector-Based Covid-19 Vaccines

Once Covid-19 vaccines become available, 5–10 billion vaccine doses should be globally distributed, stored and administered. In this commentary, we discuss how this enormous challenge could be addressed for viral vector-based Covid-19 vaccines by learning from the wealth of formulation development e...

Full description

Saved in:
Bibliographic Details
Published in:Journal of pharmaceutical sciences 2021-02, Vol.110 (2), p.627-634
Main Authors: Crommelin, Daan J.A., Volkin, David B., Hoogendoorn, Karin H., Lubiniecki, Anthony S., Jiskoot, Wim
Format: Article
Language:English
Subjects:
Covid-19
COVID-19 - immunology
COVID-19 - prevention & control
COVID-19 Vaccines - immunology
Drug Compounding
Drug Stability
Drug Storage
Formulation
Freeze Drying
Genetic Vectors
Humans
Live attenuated virus
SARS-CoV-2 - genetics
SARS-CoV-2 - immunology
Shelf life
Special Topic
Stability
Storage
Vaccine
Vaccines, Attenuated - immunology
Viral vector
Citations: Items that this one cites
Items that cite this one
Online Access:Get full text
Tags: Add Tag
No Tags, Be the first to tag this record!
Description
Summary:Once Covid-19 vaccines become available, 5–10 billion vaccine doses should be globally distributed, stored and administered. In this commentary, we discuss how this enormous challenge could be addressed for viral vector-based Covid-19 vaccines by learning from the wealth of formulation development experience gained over the years on stability issues related to live attenuated virus vaccines and viral vector vaccines for other diseases. This experience has led –over time– to major improvements on storage temperature, shelf-life and in-use stability requirements. First, we will cover work on ‘classical’ live attenuated virus vaccines as well as replication competent viral vector vaccines. Subsequently, we address replication deficient viral vector vaccines. Freeze drying and storage at 2–8 °C with a shelf life of years has become the norm. In the case of pandemics with incredibly high and urgent product demands, however, the desire for rapid and convenient distribution chains combined with short end-user storage times require that liquid formulations with shelf lives of months stored at 2–8 °C be considered. In confronting this “perfect storm” of Covid-19 vaccine stability challenges, understanding the many lessons learned from decades of development and manufacturing of live virus-based vaccines is the shortest path for finding promising and rapid solutions.
ISSN:0022-3549
1520-6017
DOI:10.1016/j.xphs.2020.11.015