Dr-Carla-GreenbaumIn August 2020, BRI Research Nurse Anna Barash, RN, gave some of the earliest doses of Pfizer’s COVID-19 vaccine to people in Washington. That day, she was laser-focused on following every step of a detailed protocol. The impact of her work didn’t sink in until later.

“I remember getting home that night and thinking ‘this is monumental,’” she says.

Anna is part of a BRI clinical research team. For decades, this team has run trials typically focused on type 1 diabetes. But COVID-19 forced the suspension of many of those studies — leaving BRI with an expert team and fewer trials to run. Around that time, Pfizer was preparing to test a potentially groundbreaking vaccine. So Carla Greenbaum, MD, director of the Center for Interventional Immunology and the Diabetes Research Program, reached out.

“The whole world was reeling from the pandemic,” Dr. Greenbaum says. “Our team had the availability and the skill set; we know how to run trials and we run them very well. So, I emailed a contact at Pfizer who connected me to someone else — and BRI became their only vaccine testing site in Western Washington.”

Three Weeks, 160+ Doses, 6 Feet Apart

Dana VanBuecken, ARNP, a sub-investigator on the Pfizer study, remembers the exact moment she learned BRI would be a testing site.

“I had this immense feeling of excitement and gratitude to play just a small part in the solution to the pandemic,” she says. “This year has been hard for everyone, but contributing to this trial gave me a tremendous sense of hope. I had so much faith in our team.”

BRI was one of about 150 Pfizer testing sites across six countries and 39 states. First, researchers opened enrollment for the trial and spread the word that they were looking for volunteers to participate in the study. Some participants would receive the vaccine, others would receive the placebo.

“Everybody wanted to participate — we could have enrolled ten times as many people,” says Dr. Greenbaum, who led BRI’s arm of the study. “We needed frontline workers to enroll, and several Virginia Mason ER doctors and those from other local hospitals were excited to get involved.”

Then came the jigsaw puzzle of logistics: They had only three weeks to give the first vaccine dose to over 80 participants — and maintaining social distancing meant they could have only a handful of people in BRI’s Clinical Research Center at a time. The research team mapped out detailed plans and schedules and worked nights and weekends to make this happen.

“This experience taught me that if something looks impossible, it’s probably not with this team,” says Research Technician Rachel Hartley.

At the end of each day, they followed another detailed protocol: They entered data about potential COVID-19 illnesses and vaccine side effects, being monitored closely by Pfizer.

“I entered the data every single day,” Rachel says. “I saw the safety measures in place and know that every box was checked, and every precaution was taken. That’s made me really confident in telling family and friends that this vaccine is a good thing and we’re really proud to be part of this work.”

Making a Difference

The-clinical-research-team-at-BRIAfter weeks of long hours, the team had given two doses of the vaccine or a placebo to 82 participants. Next, they waited: for enough data to be collected worldwide, for Pfizer to announce whether its safety and efficacy endpoints had been met, and for the FDA to independently review the data and decide whether to authorize the vaccine for emergency use.

“During that time, I kept thinking of this Thomas Edison quote that’s something like ‘I never once failed at making a lightbulb. I just found out 99 ways not to make one,’” Dana says. “That’s often how research works — and each attempt is important — but of course we really wanted this to work.”

In late 2020, the research team finally got an email from Pfizer: The FDA approved the vaccine for use during the pandemic emergency. In that moment, all of the long hours were worth it. Shortly after, Dana got a text from her sister, an ICU nurse in California.

“She sent me a picture of herself getting the Pfizer vaccine and I broke down and cried,” Dana says. “I’ve been so worried about her and others in similar roles, putting their health on the line to care for others. It’s been so gratifying to help take this vaccine from an idea to something that’s truly making a difference. It’s incredible that BRI has played a role in that.”

Category: 
Fighting Diseases

March 23, 2021

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