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1/ This new article @DrMRosenblatt offers important concerns about challenge trials that should be taken seriously, but it misses a few key points: https://www.statnews.com/2020/06/23/challenge-trials-live-coronavirus-speedy-covid-19-vaccine/">https://www.statnews.com/2020/06/2...
2/ A rescue therapy would assuage safety concerns for challenge volunteers.
But, we are entirely unprepared for challenge trials if a rescue therapy is indeed discovered. We need to prepare today in case challenges prove helpful tomorrow.
But, we are entirely unprepared for challenge trials if a rescue therapy is indeed discovered. We need to prepare today in case challenges prove helpful tomorrow.
3/ This means creating challenge doses, preparing quarantine facilities, and designing a risk-minimizing trial. These actions are cheap, non-binding, and utterly commonsensical. Ruling out safe and effective challenge trials could kill thousands.
4/ Additionally, a majority panel from the WHO voted to begin challenge trials *without a rescue therapy*. The COVID-19 mortality risk for 20-29 year olds is 3/10,000, and this rate would be lower for healthy volunteers who receive excellent healthcare. http://www.who.int/publications/m/item/feasibility-potential-value-and-limitations-of-establishing-a-closely-monitored-challenge-model-of-experimental-covid-19-infection-and-illness-in-healthy-young-adult-volunteers">https://www.who.int/publicati...
5/ That’s the same mortality risk as kidney donation and working as a trucker or logger for two years.
The risk of challenge trials are real but unexceptional compared to other acts of public service. Given the pandemic& #39;s scale, their potential social benefit is exceptional.
The risk of challenge trials are real but unexceptional compared to other acts of public service. Given the pandemic& #39;s scale, their potential social benefit is exceptional.
6/ On consenting to unknowns: we let firefighters run into burning buildings without knowing ex ante the exact risks of doing so, because tragedy demands risky action. 1Day volunteers understand that the risks aren’t entirely known. They’re still ready.
7/ On timeline: Phase III trials could take years. A challenge trial that takes months could save months in vaccine creation.
And each month is 100,000s of lives.
And each month is 100,000s of lives.
8/ Even challenge trial skeptics acknowledge this immense potential. We should prepare immediately even while the usefulness of challenge trials is uncertain. Inaction would be unjust to those who are suffering the most from this pandemic.
