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In August, I enrolled in the @moderna_tx clinical trial for the #SARSCoV2 vaccine (mRNA-1273) that has now received an #EmergencyUseApproval by the @US_FDA. I saw this as my responsibility as a clinical trialist to participate and contribute. (1/n)
I tried to encourage colleagues and other essential workers to enroll as well. It was tough to convince some folks, and I was disappointed that the trial took so many weeks to fully enroll. @moderna_tx was extremely transparent with the enrollment numbers. It was slow. (2/n)
I was convinced I got the actual vaccine and not the saline injection. I told friends and family about this, but I kept it quiet on social media. I felt a kind of "survivor's guilt" since I felt like I got early access to the vaccine. I had symptoms, (e.g. shoulder pain) (3/n)
Today, I scheduled a visit at my clinical trial site to "unblind" as I was soon to be offered access to a vaccine by my employer, and I didn't want to take someone else's "slot." I was shocked to discover that I had received placebo. My symptoms were a mirage. (4/n)
I guess a saline injection can cause a mild bit of shoulder achiness anyway. Today, at the trial site, other patients also said that some people without symptoms had received the vaccine. Some people with symptoms had received placebo, like me. (5/n)
So many commentators had argued for cutting corners in vaccine development, given this awful pandemic. I am glad to know that no corners were cut. I know this both as a clinical research scientist as well as a clinical trial volunteer. (6/n)
Randomized trials are like magic. They give us access to truth and not just gut instinct or "expert opinion" (which is almost the same thing). The truth is available to us, if we design appropriate trials and ask questions of relevance for our patients and our society (7/n)
We owe it to our fellow human beings to do what we can to reduce suffering and improve outcomes for the next patient and the next generation. Supporting research is one way to do that. Volunteering for research is another. (8/n)
The patients on the vaccine trials who receive placebo provide a critical function - a reality check to make sure that our claims of efficacy and safety hold up to strict scrutiny and stricter statistics. (9/n)
Today, I received my vaccine, the real one, from compassionate providers at my clinical trial site. But, I have been contributing data all along, and I will continue to do so, as a trial volunteer. (10/n)
There are still holes in our system. I wish, for example, that as a society, we would prioritize the health of pregnant and lactating women by INCLUDING them on clinical trials of vaccines like this. Pregnant women may be at higher risk for severe outcomes from #COVID19. (11/n)
It never really made sense to exclude pregnant women and then have to rely on organizations like @acog to make statements that the vaccines are likely safe. I appreciate @acog's help in this regard, but @US_FDA and vaccine developers should insist on inclusion. (12/n)
Nonetheless, one thing that is NOT wrong with vaccine development, and with clinical trials generally, is the use of placebo. We need that if we are to make progress. Thanks to @moderna_tx and @pfizer/ @BioNTech_Group for making some amazing vaccines, but we aren't done. (13/n)
We need more vaccines if we are going to protect the whole world, which means we need more trial participants. Consider volunteering! https://coronaviruspreventionnetwork.org/ (14/n)
And if you can't volunteer or you are in a priority group that is getting the vaccine now, please remember to #UseMasks, #SociallyDistance, & #AvoidCrowds. Too many drownings happen within sight of the shore. We can see the end of this #pandemic. (15/n)
But to save lives, we need to remind people that we can save lives today if we just #PullTogether, while #StayingApart. (16/n)
If I knew how to tag people for this thread, I would have tagged: @PeterHotez @trvrb @tmprowell @DrEricDing @DrEricLevi @ErinSandersNP @gradydoctor @vivek_murthy @atychen @ETSshow @blakewarner0 @angie_rasmussen @amybarnhorst @BallouxFrancois @jsgolub @EricTopol @mattyglesias
