Thread by @anetrid

Just out in @JAMAcurrent: The Ethics of Continuing Placebo in SARS-CoV-2 Vaccine Trials w/ @mlipsitch and #FrankMiller

A thread with updates on recent developments 1/n jamanetwork.com/journals/jama/…

After @pfizer @BioNTech_Group vaccine was granted @US_FDA #EUA last week, one question on everyone’s mind is: when should vaccine be offered to participants in placebo group? 2/n

We argue: Given limited vaccine supply for at least several months, only those participants on placebo who would be eligible for vaccination outside the trial should be offered vaccine for now 3/n

1- Important data on vaccine safety and efficacy can be gathered by keeping participants on placebo who are not eligible for vaccination outside the trial, and they are not being made worse off than they would and should have been outside the trial 4/n

2- Keeping participants on placebo who are not eligible for vaccination outside the trial means that limited vaccine can go to people higher up on the priority list (e.g. healthcare workers, older people as per @CDCgov @theNASEM) 5/n

3- Participants’ contribution to the research should be rewarded by giving them extra priority (e.g. healthcare workers who have also enrolled in trial should be first to be vaccinated), but they should not placed ahead of people higher up on the priority list for vaccination 6/n

Since we got this paper ready for publication, @goodmanmetrics made similar points in @US_FDA #VRBPAC meeting last week 7/n fda.gov/media/144354/d…

As per @US_FDA #VRBPAC briefing doc, @pfizer also seems to make plans along similar lines 8/n fda.gov/media/144245/d…

And a much broader paper on SARS-CoV-2 vaccine trial design post-EUA was published by my amazing @NIHBioethics colleagues last week in @ScienceMagazine - check it out here! /fin science.sciencemag.org/content/370/65…

Some great comments and responses to yesterday's @JAMA_current piece with @mlipsitch and #FrankMiller - so planning to (slowly - busy days!) continue this thread in an effort to respond to key points

jamanetwork.com/journals/jama/…