groups » COVAX Clinical Development SWAT TEAM Workshops Group » Part 2: Clinical development gaps
We would welcome anybody interested in participating in the above workshop to already let us know here what you hope to get out of the workshop.
You may also want to post any comments during the workshop or continue the discussions afterwards.
We are looking forward to lively discussions!
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The report of this workshop has been uploaded. See (beginning of) executive summary below and full report here: https://media.tghn.org/medialibrary/2021/02/COVAX_Emerging_Challenges_Workshop_REPORT.pdf.
Executive summary
On 28th January 2021, the COVAX Clinical Development & Operations SWAT Team hosted a
workshop on “Emerging Challenges to the Development of COVID-19 Vaccines.” The main
aims were to discuss developer needs and propose solutions for the progression of “Wave 2”
vaccines towards emergency use authorisation (EUA)/licensure in the setting of the
introduction and limited availability of new vaccines, to review recently emerging data on
severe acute respiratory syndrome coronavirus 2 (SARS CoV-2) variants to better
understand the potential relevance for existing vaccines, and to review research
opportunities and data gaps based on immunological principles and previous vaccine
experience to understand how to better use available vaccines.
The first part of the workshop focused on the path to approval of additional COVID-19
vaccines.
Key points included:
• Multiple sources of data will contribute to identification of a correlate of protection,
including data from Phase 3 efficacy studies, natural history studies including reinfection studies, and passive immunisation (human and animal studies), and early
evidence supports the relationship between neutralizing antibodies and protection.
• Sponsors and owners of primary data from efficacy studies are encouraged to share
information on breakthrough cases and correlates analyses as soon as possible. The
World Health Organization (WHO) International Standard should be used for respective
analyses. -
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