The Science is There: Key Considerations for Stabilizing Viral Vector-Based Covid-19 Vaccines.
J Pharm Sci
; 110(2): 627-634, 2021 02.
Article
in English
| MEDLINE | ID: covidwho-1060168
ABSTRACT
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.
Keywords
Full text:
Available
Collection:
International databases
Database:
MEDLINE
Main subject:
Drug Stability
/
COVID-19 Vaccines
/
Genetic Vectors
/
SARS-CoV-2
/
COVID-19
Type of study:
Observational study
Topics:
Vaccines
Limits:
Humans
Language:
English
Journal:
J Pharm Sci
Year:
2021
Document Type:
Article
Affiliation country:
J.xphs.2020.11.015
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