This idea of allowing some people access to an investigational vaccine WHILE a randomized trial is ongoing is not a serious proposal

The fact it is made on twitter & a blog post is evidence of that.

Here is why: [thread]

1. As vaccine is manufactured it must be prioritized for randomized trial use. If production is ramped up, the trial should be made larger, or vaccine compared against 2nd vac.

You don't get to take party favors from the vaccine plant.

2. There are several candidate vaccines, and there is no assurance whether 0/1/ more than one will be successful. The prob is probably lower than rhetoric.

3. If you give people a vaccine and say "this is an unproven COVID vaccine-- warning: it may not work!"

Some people will think it works, and their behavior may be less guarded, more risky, and you can worsen a pandemic

"I got the vaccine!"

4 If you give people an unproven vaccine and 3 have guianne barre-- they may rightly or wrongly attribute it to your vaccine. This can kill the vaccines' development. An RCT is needed to know that safety sign is > chance.

If your vaccine is successful, enthusiasm may be low.

5. If a vaccine is effective, how we deploy it is a public health question.

Its limited supply must be deployed in ways to quell the epidemic spread. Not just given to rich people who want it.

6. I keep saying this program would be used by rich, well connected people-- of course it would!

These access programs are not equitable, and this will certainly not be

Meanwhile the disease is raving minority communities.

7. If the candidate vaccine you deploy broadly fails, or is net harmful, you may reduce enthusiasm for vaccine #2 if this is efficacious

"I already got a COVID vaccine.. they are all bullshit"

8. IF you deploy a covid vaccine that is weakly effective, and some vaccinated people get COVID and complain on TV about it, that may kill enthusiasm for widespread vaccination, even if 20% reduction in COVID is valuable from a public health standpoint

9. Now, I see the revised the proposal is to permit randomization in the expanded access portion of the study.

This is total nonsense. That is just making the RCT larger!

Why is someone saying nonsense??

10. I am glad to know this problem was invented by social media and will end on social media.

I am confident that even though the US totally bungled this pandemic, there is no one who will take this proposal seriously

11. If you want to say something useful, perhaps a p3 vaccine trial with continuous enrollment, and multiarm design

Ask some of the great bayesian stats folks for tips on adaptive randomization.

That is a serious proposal, this is not

12. Oh and pet peeve. Folks making this absolutely bad proposal state "but people are dying" and feign that they are more concerned about it

We are all concerned

Just some of us think through our proposals before uttering them

13. This is really a topic best suited to a white paper or full article and not a tweet.

Please stop spitballing ideas

14. The fact that these views get such massive RTs
should strike fear in all our hearts