RCT trials for COVID study vaccines

Inviting discussion on full versus Emergency Use vaccine approvals/authorizations.

Two perspectives on same - each highlight the problem of the impact of a full approval or an EUA on the conduct of other vaccine trials – such as the ethical issue of blinding:

The Vaccine Tightrope
By Derek Lowe https://blogs.sciencemag.org/pipeline/archives/2020/10/21/the-vaccine-tightrope

Early approval of a COVID-19 vaccine could stymie the hunt for better ones
By Jon Cohen https://www.sciencemag.org/news/2020/10/early-approval-covid-19-vaccine-could-stymie-hunt-better-ones

Here’s my shot from the hip notion.

Since masks & distancing work (for countries where there is public adherance to the policies such as Japan, South Korea), do the vaccine studies right – wait for RCT evidence to mature to see if they merit full approval; discard EUA fuzzy logic based on signals that it might work).

The public needs to have confidence in the findings in order to achieve herd immunity. Subsequent study of vaccines should have as a control a vaccine that is well characterized as to its safety and efficacy overall and for different risk populations.

But what happens to the other vaccine studies? A proven vaccine makes the continued use of a placebo control unethical.

To support continued RCT study of the remaining vaccines, I think it will require switching the control from placebo to the first vaccine that wins full approval and unblinding to allow participants to opt into the adapted study (study vaccine vs approved vaccine) or take the approved vaccine off study.

…A statisticians nightmare I imagine. Is there another feasible/ethical approach? How might switching the control work? Would the data generated from a placebo control still be useful? I imagine yes (somewhat) for safety, but less so for efficacy.

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