Conventional thinking is costing lives

As I write this, the US has averaged over 3,000 COVID-19 deaths a day (over a seven-day period) every day for nearly a month. Yet, the US has only distributed 65% of its vaccine supply. In terms of total vaccine distribution per 100 people, we’ve distributed a sixth of what Israel has, a fourth of what the UAE has, and only two-thirds of the UK. 

Israel is already seeing a return on investment. 

Given the quickly rising death toll in the US, you’d think it would be an “all hands-on deck” situation. You’d think the federal government and their state partners would do whatever was necessary to speed up the distribution of COVID-19 vaccine. No idea should be too outside the box to at least consider. You’d be wrong. Conventional thinking among the public health establishment has resisted any innovative ideas which would save lives. Governments are stubbornly sticking to narrowly tested plans and refusing to extrapolate based on what we’ve learned. 

First dose first 

First dose first (FDF) is the idea that among two dose COVID-19 vaccines the first doses should be distributed as quickly and as widely as possible without concern as to when a second dose would be given. The reason is simple: the first dose is still highly effective– and just as safe– on its own as it is when paired with a booster shot. 

FDF Advocates have sketched out the math behind their argument, yet opponents haven’t been able to show why they are wrong. As economist Tyler Cowen noted: “I have been asking people to provide comparable back-of-the-envelope calculations against First Doses First. What is remarkable is that I cannot find a single example of a person who has done so… Show your work people!”

FDF also provides an added benefit: added time between the prime shot and the booster shot should increase effectiveness. For most other vaccines we have, the booster shot is more effective with time. The reason the short time frame was chosen over a longer time frame was because we didn’t have time to wait. The shortest effective wait was chosen– not the most effective wait. 

This strategy is safe. There is no reason why delaying the second dose for a few weeks– or even a few months– would be harmful. Both Israel and the UK have adopted FDF and both are monitoring those who get a COVID-19 vaccine. Neither has found any evidence to suggest drawbacks yet. Sure, there would be some mysterious drawback, but we know of real drawbacks of waiting. We don’t have time to wait around until we are absolutely sure about every decision we make. 

Update: After I published this, I came across an Alex Tabarrok article outlying recent developments in the evidence for and momentum behind FDF. Read it here.

Half doses instead of full doses

Another strategy is giving half-doses instead of full doses. Moderna’s phase 3 trial data shows that a 50-milligram dose has an “identical immune response” as the 100-milligram dose. Even Moncef Slaoui– the former head of Operation Warp Speed– has endorsed this plan. 

Approve the AstraZeneca vaccine 

AstraZeneca is another company that has produced an effective and safe COVID-19 vaccine. It’s being used in both the UK and EU. It won’t be approved in the US for months. Why? The FDA is requiring AstraZeneca to redo their phase 3 trail. While AstraZeneca has a production facility in Baltimore that is already producing doses, the FDA is holding them back. And if that wasn’t bad enough, the AstraZeneca vaccine is one of the easiest COVID-19 vaccines to distribute because it doesn’t require freezing. 

Let Moderna increase their production by 50%! 

Moderna could increase their vaccine production by 50%, but the FDA hasn’t signed off on it yet. The vials Moderna uses for their COVID-19 vaccine can hold 15 doses but they’re currently only approved for 10 doses. They’ve asked the FDA to approve adding extra doses to each vial, yet it will be “weeks” before the FDA gets back to them. That means Moderna will be shipping out millions of doses less over the next few weeks than it could. 

Why?

As thousands die every day, the FDA is standing around doing nothing. The FDA has long been plagued with incentive problems. Thousands dying from a pharmaceutical that shouldn’t have been approved makes for front page news. It gets budgets cut and officials dragged before Congress. Thousands dying because a drug that should have been approved and wasn’t is a nonstory. The FDA is pressured by real graveyards– not invisible ones. 

In early January the FDA issued a statement responding to calls for more aggressive distributional approaches. Their response was that we should thousands more die as they study the suggestions.

These are all reasonable questions to consider and evaluate in clinical trials. However, at this time, suggesting changes to the FDA-authorized dosing or schedules of these vaccines is premature and not rooted solidly in the available evidence. Without appropriate data supporting such changes in vaccine administration, we run a significant risk of placing public health at risk, undermining the historic vaccination efforts to protect the population from COVID-19.

The FDA: 

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