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The Capital Region of Denmark - a part of Copenhagen University Hospital
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Ongoing and future COVID-19 vaccine clinical trials: challenges and opportunities

Research output: Contribution to journalReviewResearchpeer-review

  1. The importance of enterovirus surveillance in a post-polio world

    Research output: Contribution to journalReviewResearchpeer-review

  2. Is oropharyngeal sampling a reliable test to detect SARS-CoV-2?

    Research output: Contribution to journalLetterResearchpeer-review

  3. Specificity and cross-reactivity of a test for anti-SARS-CoV-2 antibodies - Authors' reply

    Research output: Contribution to journalLetterResearchpeer-review

  • Rafael Dal-Ré
  • Linda-Gail Bekker
  • Christian Gluud
  • Søren Holm
  • Vivekanand Jha
  • Gregory A Poland
  • Frits R Rosendaal
  • Brigitte Schwarzer-Daum
  • Esperança Sevene
  • Halidou Tinto
  • Teck Chuan Voo
  • Nadarajah Sreeharan
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Large-scale deployment of COVID-19 vaccines will seriously affect the ongoing phases 2 and 3 randomised placebo-controlled trials assessing SARS-CoV-2 vaccine candidates. The effect will be particularly acute in high-income countries where the entire adult or older population could be vaccinated by late 2021. Regrettably, only a small proportion of the population in many low-income and middle-income countries will have access to available vaccines. Sponsors of COVID-19 vaccine candidates currently in phase 2 or initiating phase 3 trials in 2021 should consider continuing the research in countries with limited affordability and availability of COVID-19 vaccines. Several ethical principles must be implemented to ensure the equitable, non-exploitative, and respectful conduct of trials in resource-poor settings. Once sufficient knowledge on the immunogenicity response to COVID-19 vaccines is acquired, non-inferiority immunogenicity trials-comparing the immune response of a vaccine candidate to that of an authorised vaccine-would probably be the most common trial design. Until then, placebo-controlled, double-blind, crossover trials will continue to play a role in the development of new vaccine candidates. WHO or the Council for International Organizations of Medical Sciences should define an ethical framework for the requirements and benefits for trial participants and host communities in resource-poor settings that should require commitment from all vaccine candidate sponsors from high-income countries.

Original languageEnglish
JournalThe Lancet Infectious Diseases
Volume21
Issue number11
Pages (from-to)e342-e347
ISSN1473-3099
DOIs
Publication statusPublished - Nov 2021

ID: 67052362