tetano
Editor, Senior Moderator
Clin Trials
. 2024 Mar 29:17407745241238925.
doi: 10.1177/17407745241238925. Online ahead of print. Challenges in conducting efficacy trials for new COVID-19 vaccines in developed countries
Rafael Dal-Ré[SUP] 1 [/SUP], Emmanuel Bottieau[SUP] 2 [/SUP], Odile Launay[SUP] 3 [/SUP], Frits R Rosendaal[SUP] 4 [/SUP], Brigitte Schwarzer-Daum[SUP] 5 [/SUP]
Affiliations
The protection from COVID-19 vaccination wanes a few months post-administration of the primary vaccination series or booster doses. New COVID-19 vaccine candidates aiming to help control COVID-19 should show long-term efficacy, allowing a possible annual administration. Until correlates of protection are strongly associated with long-term protection, it has been suggested that any new COVID-19 vaccine candidate must demonstrate at least 75% efficacy (although a 40%-60% efficacy would be sufficient) at 12 months in preventing illness in all age groups within a large randomized controlled efficacy trial. This article discusses four of the many scientific, ethical, and operational challenges that these trials will face in developed countries, focusing on a pivotal trial in adults. These challenges are (1) the comparator and trial population; (2) how to enroll sufficient numbers of adult participants of all age groups considering that countries will recommend COVID-19 booster doses to different populations; (3) whether having access to a comparator booster for the trial is actually feasible; and (4) the changing epidemiology of severe acute respiratory syndrome coronavirus 2 across countries involved in the trial. It is desirable that regulatory agencies publish guidance on the requirements that a trial like the one discussed should comply with to be acceptable from a regulatory standpoint. Ideally, this should happen even before there is a vaccine candidate that could fulfill the requirements mentioned above, as it would allow an open discussion among all stakeholders on its appropriateness and feasibility.
Keywords: COVID-19; booster vaccines; long protection; mild illness; pivotal trial; trial design.
. 2024 Mar 29:17407745241238925.
doi: 10.1177/17407745241238925. Online ahead of print. Challenges in conducting efficacy trials for new COVID-19 vaccines in developed countries
Rafael Dal-Ré[SUP] 1 [/SUP], Emmanuel Bottieau[SUP] 2 [/SUP], Odile Launay[SUP] 3 [/SUP], Frits R Rosendaal[SUP] 4 [/SUP], Brigitte Schwarzer-Daum[SUP] 5 [/SUP]
Affiliations
- PMID: 38551193
- DOI: 10.1177/17407745241238925
The protection from COVID-19 vaccination wanes a few months post-administration of the primary vaccination series or booster doses. New COVID-19 vaccine candidates aiming to help control COVID-19 should show long-term efficacy, allowing a possible annual administration. Until correlates of protection are strongly associated with long-term protection, it has been suggested that any new COVID-19 vaccine candidate must demonstrate at least 75% efficacy (although a 40%-60% efficacy would be sufficient) at 12 months in preventing illness in all age groups within a large randomized controlled efficacy trial. This article discusses four of the many scientific, ethical, and operational challenges that these trials will face in developed countries, focusing on a pivotal trial in adults. These challenges are (1) the comparator and trial population; (2) how to enroll sufficient numbers of adult participants of all age groups considering that countries will recommend COVID-19 booster doses to different populations; (3) whether having access to a comparator booster for the trial is actually feasible; and (4) the changing epidemiology of severe acute respiratory syndrome coronavirus 2 across countries involved in the trial. It is desirable that regulatory agencies publish guidance on the requirements that a trial like the one discussed should comply with to be acceptable from a regulatory standpoint. Ideally, this should happen even before there is a vaccine candidate that could fulfill the requirements mentioned above, as it would allow an open discussion among all stakeholders on its appropriateness and feasibility.
Keywords: COVID-19; booster vaccines; long protection; mild illness; pivotal trial; trial design.