So hey the NYT is saying that the Pfizer/BionTech vaccine may get emergency authorization next month: https://nyti.ms/2GTMq0C 

This is the vaccine trial I'm in and people have been really nervous about this vaccine, so since I have the IRB disclosure docs in front of me I thought I'd use them to do a little FAQ. Pictures are of the actual IRB disclosure docs I was given by Wake research.

Some people have been very concerned that the vaccine might give me COVID-19 or make me contagious. Here's the part of the IRB disclosure that addresses how messenger RNA vaccines work. Transcript to follow in next tweets.

Transcript (not doing as alt text so folks using screen readers can have a trusted sighted person confirm them if they want):
These vaccines do not contain the whole virus or the parts of the virus that can make you ill, instead the vaccines are made up of

part of the virus's genetic code, surrounded by fatty particles called lipids. They use your own cells' protein making machinery to produce some, or all, of the spike protein seen on the outside of the virus. This spike protein, made by your own body, may help your body to

produce antibodies to fight against COVID-19. We will check how many antibodies you make by taking blood samples and testing them.

End transcript, me again. That excerpt refers to multiple vaccines because they didn't change it between phase 1, when they investigated a couple different ones, and the phase 2/3 trial they're doing now.

Because I was obsessively tracking soreness and warmth in my arm after my first injection, some people suggested that the placebo might have irritants added. Here's the description of phase 2/3 specifying the placebo:

Transcript:
You are being asked to participate in Phase 2/3.

The study will compare the results of the people who receive the study vaccine with those who receive a placebo (a placebo looks like the study vaccine but does not contain any active ingredients). In this study the

placebo will be salt-water, also known as normal saline. Everyone in Phase 2/3 of the study will receive 2 injections of either:
- Study vaccine followed by study vaccine
- Placebo followed by placebo

In Phase 2/3 everyone who receives the study vaccine will receive the same vaccine at the same dose, that was chosen based on the results from Phase 1.

End transcript, me again. This differs from the study design as it was described to me on the phone when I was recruited - the woman then told me everyone was getting vaccine as the second shot. I'm not really concerned, the IRB doc is what matters.

And honestly I'm not in this to get the vaccine, I'm in this to help develop the vaccine, because we have to end the pandemic.

I highly recommend reading the NYT article in the first tweet of this thread. Distribution is a concern! The vaccine needs a temp of - 94F for long term storage. Other options are to keep it in a normal freezer (5 day limit) or it can be kept in its special cooler (15 days) l

They DO NOT inject it at those temps! It would cause tissue damage. It is warmed to safe temps for injection. I guarantee you have received other vaccines that are kept in the freezer and did not notice.

I also guarantee I would have noticed the screaming on site if people were getting injected with roughly 1cc of fluid at -94F in their deltoid muscle. They have us hang out in a waiting room for 30 minutes afterward, people would have still been screaming.

Sorry it's very difficult for me to not be irreverent.

Also this vax requires 2 doses, 3 weeks apart. It's going to be really important that you not only get the vaccine when it's available to you, but that you get both doses.

I have come to WombatHaus now to do laundry and don't have the IRB doc in front of me anymore, but 44,000+ people are participating in this trial between both phases. This phase is recruiting down to age 12.

It's something like 44,398 people.

So look I can't promise you nobody out there is going to have a bad reaction to this vaccine. But me and 44,397 other people have put our bodies on the line to make it safe and effective for you.

We are volunteers. We don't get bumped to the front of the line for the vaccine if we got the placebo. We get $119 for each of the six site visits we have to make, and $5 if they look at our weekly covid symptom diary.

We have phone numbers and email addresses so we can ask questions of study doctors. We have contact info for the IRB in case the study doctors are jerking us around. The study is as voluntary and clearly explained as they can make it.

This is correct! I talked to the study doc and they would have to pause the study even if eg someone died for a reason clearly not study related. No one has. https://twitter.com/snaefell/status/1327966443497992192?s=19

The study doc told me a story about having to pause one study because a participant got decapitated in a car wreck. He said it was very frustrating. Also he said if I grow a tentacle or am diagnosed with a weird zoonotic sheep disease those would also affect the study.

He would prefer therefore that I not do those things.

Then he told me a fascinating story about a patient he had once with an encapsulated parasite in her spleen that she got from sheep.

And then the nurse came in and was like "Give me the patient we have a schedule" in attitude if not in words and we had to stop talking about weird zoonotic sheep diseases.

Anyway. I hope this all helps you feel a little more reassured. The study is 26 months long and one of the things I want to ask them tomorrow is about when I should get the covid vaccine once it becomes available to me.

I don't expect they will tell me whether I got vaccine or placebo for sure until after the trial is over, and it's a 26 month trial. So uh. I'd kinda like the vax for sure before then?

So this is a really good question and I want to answer it as a quote tweet so more people see it.

In trials for disease treatments, if a trial shows high efficacy, placebo patients sometimes get the treatment because it's inhumane not to give it. https://twitter.com/hoffsbeefs/status/1327974504056885249?s=19

In this case, we're talking a vaccine for a really nasty novel disease.

My life puts me at low risk for contracting it, and I'm at pretty low risk for complications if I do get it. I signed up for the trial having read the IRB disclosure.

So I knew there was only a 50/50 chance I would end up getting the vaccine as part of the trial.

At this early point, available doses will be really limited. Given my low risk, I'm very ok not getting the vaccine if I'm in the placebo group.

There's a ton of people out there who need the vaccine more than I do to keep them safe. Health care providers. Immunocompromised people and their families. Front line workers like the people keeping grocery stores up and running.

There is zero reason for a hermit of a sheep farmer to get the vaccine before those people get taken care of. I am absolutely fine not getting it if it means one person who legit is on the front lines of this thing and living in terror of dying of it can get it.

I am in this trial because I have beloved friends and family who will die if they get this disease, and other people do too. The only thing covid changed about my routine is that now I wear a mask on my weekly or less frequent trips to the store.

TL;DR how do I feel about me possibly not getting the vaccine early if there's an EUA?

Y'all, I don't care. Save a life and give that dose to somebody who seriously needs it.