This is correct. We have lots of infrastructure and expertise for making new flu vaccines every year. It's not a good model for how long we should expect safety testing to take for a vaccine for a new virus. We don't have any licensed vaccines for any coronavirus, for example.

[ Question ]

Does the 14-month vaccine safety test make sense for COVID-19?

by orthonormal 1 min read18th Mar 202014 comments


I was first wondering why, if we keep hearing about teams rapidly generating vaccines for COVID-19, the common wisdom is that it will take 18 months to start vaccinating at a large scale.

Turns out that the scaling up takes a few months, but the real blocker is the Phase 1 trial, which requires monitoring patient health for 14 months after vaccination.

Doesn't it seem like the cost-benefit analysis changes a bit if we're in the midst of a pandemic? Wouldn't it be worth cutting it down to e.g. 3 months before at least vaccinating the highest-risk populations? Is anyone official even thinking about this?

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From what I can tell, it looks like the main danger is with a live vaccine, where the vaccine can give the disease to a large number of people (biggest actual disaster seems to have been the Cutter incident, which infected 40,000 people with polio).

I assume that the trial is also there to catch potential black swan issues.

IIRC the Covid-19 vaccines on trial are not live, so the case for doing the 14 month watch was not as strong as I expected. Certainly worth considering more carefully at least.

I don't think the timeline for Phase 1 trials looks anything like a 14 month delay before Phase 2 trials start.

  • [] already mentioned the live vs inactivated vaccine distinction.

  • Metaculus (admittedly not the best source of predictions) gives 45% that a vaccine is distributed starting in 2020. One user gives only 70%, taking into account the high urgency and high risk-tolerance of countries like China.

  • The American NIH says "If the clinical trial enrolls participants as planned, researchers hope to have initial data from the clinical trial within three months." This means either (a) they're being slightly misleading, or (b) that further trials will start immediately after that point.

I can't remember the term it's antibody specific amplification or something, but some promising vaccines will actually make you more susceptible.

I think we will likely get some acceleration out of heroic volunteers, if not in the US then elsewhere.