Vaccines Europe Analysis of Vaccine Production Lead Times

Executive Summary

Background: Since technological developments and the response to the COVID-19 pandemic have the
potential to impact vaccine manufacturing, this research was conducted on mRNA and viral vector–
based COVID-19 vaccines in Q4 2022 using similar methods to a Vaccines Europe analysis of vaccine
production lead times in 2015-18.

Results: Based upon interviews with industry subject matter experts, production lead times under
pandemic-emergency conditions were estimated to be 3.5–6 months for viral vector and 2.5–5.5
months for mRNA-based COVID-19 vaccines. Differences between mRNA and viral vaccines were
accounted for by the upstream manufacturing process (1.5–3 months for viral vector and ~1 month
for mRNA-based vaccines), reflecting the time for cell culture, bioassay validation, and quality
requirements for viral vector manufacturing.

Discussion/conclusions: The pandemic imposed variable effects on the supply of COVID-19 vaccines.
Factors accelerating time to market due to the pandemic included early investment in manufacturing
and advanced agreements to support at-risk and/or in-parallel processes, prior to standard regulatory
authorisations. Additional factors improving time to market included unprecedented collaboration
and partnerships among vaccine manufacturers, regulators and control laboratories, simplified
presentations, in-process inspection controls, and simplified administrative procedures and
paperwork. Some of the factors accelerating production lead time during the pandemic could be
adopted further and applied in a non-pandemic situation, such as further international harmonisation
of regulatory processes, simplification of package requirements, and early dialogue between key
stakeholders. Constraints inherent to vaccine manufacturing limit the ability to further accelerate
production lead times, and the time needed to make vaccines available to end users does not
principally depend on manufacturing. Steps excluded from this analysis include lengthy high-risk R&D,
and quality assurance of materials and equipment; post-release testing; supply, shipment, and vaccine
administration to end users. Accelerated lead times achieved during the pandemic were minimally
impacted by production lead times and largely made possible by exceptional repurposing of preexisting technology platforms and unprecedented investment in research, development, and
manufacturing scale-up. While new vaccine platforms and lessons from the pandemic have the
potential to impact production lead times, sustained investment across vaccine types and technology
platforms remains essential to address the challenges of communicable diseases, as no one platform
is likely to be suitable for all pathogens.