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!

Reply

  • sonjahenne Sonja Henne 19 Feb 2021

    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.

  • sonjahenne Sonja Henne 29 Jan 2021

    Please create any new forum entries for topics from the workshop you wish to further discuss.

Please Sign in (or Register) to view further.