THREAD: This year’s #shotwave tweet is unusual. Not about a flu shot (though I got one back in September). This year I am participating in a randomized, controlled trial with my mom. We are both enrolled in a #COVID-19 vaccine trial. 1/15 @DrsMeena #StandBackImGoingToTryScience

We enrolled on day 1 at our University of Michigan site, in the Michigan Clinical Research Unit (MCRU), where I enroll and see a lot of #IBD patients participating in clinical trials. #IBD patients (on immunosuppression +/- steroids) would not be eligible for this study. 2/15

20K participants will get vaccine, 10K will get salt water (saline) placebo. This is one of 4 vaccines that are likely to be ready in large numbers in January (if they work and are safe) 3/15

Why did I participate? In part, because my patients can’t. And they need an effective vaccine (preferably, multiple effective vaccines) as quickly as possible. And lots of my patients volunteer for trials to get access to new therapies before they reach the market. 4/15

I figure this is my turn to volunteer. Even if I get placebo, I will have helped move a (likely) effective vaccine closer to approval, and helped establish safety. We need a lot of doses – about 640M for the US, about 15B for the whole world. 5/15

Why did my mom do this with me? In part, she is high risk (75 y/o) and would love to go back to socializing normally and seeing people again. But it is also family tradition to participate in vaccine trials, going back to 1954. 6/15

In 1953, her baby brother, Robert (Bo), was diagnosed with polio, and spent more than 6 months in a hospital recovering motor function. When the Salk vaccine trial was announced, her parents made sure to get their other kids in line. (picture of Bo ~ 50 y later w/family) 7/15

My mom was 8 years old when she got an injection at her local fire house with 2 of her brothers (Polio Pioneers). They were cluster-randomized by fire station, so they all got placebo (but did not get polio that summer – all the pools were shut down) 8/15

More than a million children were enrolled, still the largest randomized controlled trial in human history. When the trial results were announced on April 12, 1955, it was done live at an international press conference in Rackham Auditorium at the University of Michigan. 9/15

Because Salk was a virologist, he needed a clinical trialist to test the vaccine, especially with the low event rate. He knew Tommy Francis (his former mentor) was the right person. Dr. Francis had embraced the new (at the time) technology of punchcard computing. 10/15

The press conference was broadcast live in every country in the world, and began with “The vaccine works. It is safe, effective, and potent.” https://president.umich.edu/wp-content/uploads/sites/3/2015/02/markel.pdf 11/15

So, in the fall of 1955, all of the children who received placebo (including my mom and her brothers) went back to their local fire stations to get the Salk vaccine (for free) before they returned to school. 12/15

Today there is a plaque on the 5th floor of the University of Michigan hospital dedicated to Tommy Francis, and residents rotate on the Francis service. 13/15

Vaccine technology has changed a lot (mRNA vaccines, adenovirus vaccines with exchangeable cassettes), but the need for lots of volunteers hasn’t. My mom and I will be getting our 2nd injections this Friday. I hope you will consider volunteering for a trial. 13/15

We will have to science our way out of COVID-19, as public health measures have not worked well in the US (unlike NZ and Australia), largely due to poor leadership. I hope you will consider joining a vaccine trial 14/15

And I hope you will get vaccinated when we have approved vaccines available. #shotwave https://mmheadlines.org/2020/11/covid-19-vaccine-trial-volunteers-explain-why-they-signed-up/ 15/15