This article was originally published here
Vaccine. 2022 Feb 23;40(9):1215-1222. doi: 10.1016/j.vaccine.2021.11.098.
The COVID-19 pandemic has proven to be an unprecedented challenge for vaccines which are widely recognized as the most important tool to emerge from this pandemic. We’ve seen vaccine scientists, developers, manufacturers, and stakeholders deliver multiple vaccines in roughly a year. This is an unprecedented achievement in an environment that was not prepared to handle such a global public health crisis. Indeed, the pandemic has highlighted some hurdles that need to be overcome in the system in order to streamline regulatory processes and move into a situation where life-saving pharmaceutical solutions such as vaccines can be delivered quickly and equitably to people around the world. whole. Specifically, trade-offs had to be made between the need for regulatory flexibility in manufacturing and control requirements to enable rapid availability of large volumes of vaccines versus the increased rigor and lack of harmonization in the global vaccine regulatory environment. It is also characterized by great heterogeneity in terms of review and approval processes, limiting fair and timely access. We review and highlight challenges related to several topics, including process validation, comparability, stability, post-approval modifications, release testing, packaging, genetically modified organisms and variants. We see four areas for accelerating access to vaccines that provide solutions to regulatory concerns, (1) science and risk-based approaches, (2) global regulatory harmonization, (3) use of process of dependency, work sharing and recognition and (4) digitization. These solutions are not new and have already been put forward. Over the past few months, we have seen progress at the level of health authorities, but there is still much to do. Now is the time to reflect on the early lessons learned from a devastating pandemic to ultimately ensure rapid and widespread access to medicines and vaccines for citizens and patients.
PMID:35180993 | DOI:10.1016/j.vaccine.2021.11.098