Monday, November 23, 2020

Meet America's Clinical Trial Volunteer Heroes

They are nameless, faceless and unsung.  They could be a grad student, a writer or that individual you passed in the grocery aisle. These invisible Americans are risking their personal health to volunteer for about a 1,000 COVID-related research trials in our country. They are America's newest heroes.

Upwards of 100,000 Americans have volunteered for vaccine trials in America.  Thousands are participating in drug trials in other nations. Without these volunteers, the clinical trials required to approve the vaccines would be impossible.  The research ensures the vaccine's safety and effectiveness.

Let's reveal the identities of a few of these courageous volunteers: Ian Haydon, a 29-year old from Seattle. Sophia Upshaw, a 22-year-old graduate student from Atlanta.  Jennifer Haller, a 43-year-old mother of two. And Elle Hardy, an Australian freelance writer based in the United States.

Their personal stories reflect something about the nearly undefinable American spirit.  People in our country are imbued with a desire to help others out of a sense of patriotic duty.  We don't read or hear much about this trait any more yet it is instilled in all who believe in the principles of this country.

Take Jennifer Haller for example.  She had participated in other clinical research trials before volunteering for the COVID test.  Her son had enrolled in three medical trials unrelated to the virus.  She believes in the power of clinical studies, recognizing their value to protect the lives of others.

When she volunteered for the COVID trial by Kaiser Permanente, Jennifer did not realize she would be the very first patient receiving a vaccine that had never been tested on human beings.  Was she frightened? Did she consider aborting the opportunity?  Allow Jennifer to answer in her own words.

"No.  But not because I am super strong, but because I wanted to be able to give something back and contribute in some way.  A lot of people can't do something like what I'm doing.  They couldn't potentially take off work or be healthy enough to participate..." she says in a CNN interview. 

Her unselfishness is inspiring.  So is the story of volunteer Ian Haydon, who endured a systemic adverse reaction to the vaccine being developed by Moderna Therapeutics.  He is one of three people in the research effort to experience side effects from the revolutionary vaccine.

Moderna, a Cambridge, Massachusetts, based pharmaceutical firm, is using a genetic material that triggers the body to create a protein that trains the immune system to recognize the virus as an invader. Moderna partnered with the National Institute of Allergy and Infectious Disease (NAID). 

Despite suffering a negative reaction, Haydon endorses the vaccine. "I understand that sharing the story, it's going to be frightening to some people.  I hope that it doesn't fuel any sort of general antagonism towards vaccines in general or towards even this vaccine, " he allows. 

Haydon's concern for others motivated him to sign up for the Phase I trail designed to be the first opportunity for researchers to evaluate the vaccine on humans. Although the vaccine made him sick, Haydon would do it again. "I don't regret the decision I made to enroll in this study."

Spoken like a patriot swayed by his altruism.  Haydon, a communications manager, learned about the study from a colleague who forwarded a link.  Even though he admittedly "doesn't like needles," He immediately applied and eleven days later Moderna contacted him.  Bravery in action.

Sophia Upshaw also leaped at the chance to help advance research on a vaccine.  "It's something I could do," she told Science News.  "We are all feeling helpless and trying to help in any way we can...Everyone is trying to do what they can," she explains.  

Sophia concedes her family was worried about her participation. "They are happy that people are choosing to participate in the trial. They're just not happy that it's me," she admits in an interview.  Her parents were relieved when Sophia did not develop a severe reaction to the vaccine.

Elle Hardy's original journey from journalist to clinical research volunteer was spurred by simple economics.  She was broke.  That sparked her interest in a medical trial for an anthrax vaccine several years ago.   She made a few dollars, but research volunteers certainly don't get rich.  

She was in South Korea this February doing research on a major Coronavirus outbreak and managed to escape infection.  She returned to her native Australia, but eventually flew to the U.S. to continue her freelance journalist career.  An opportunity arose when recruiting began for a Phase III clinical trial. 

"I wish I could say that I signed up for the vaccine trial out of some sense of public service.  But my first response when I was asked to take part in the trial was, 'Hell yes,' because I wanted a chance to get some protection from the Coronavirus as soon as possible," Elle confesses in a story in Business Insider.

Before she was admitted to the trial, the clinic reviewed her medial history, her medications, administered a pregnancy test, measured her blood pressure and pulse and extracted eight vials of her blood. Throughout the trial the clinicians monitored her blood samples.  

The trial was the Phase III test for Moderna's mRNA-1273 vaccine, which the pharmaceutical firm announced results show the drug is 94.5% effective.  Elle was one of 30,000 people enrolled in the study across multiple sites in the United States.  Participants were either given the vaccine or a placebo.

Elle is certain she did not receive the placebo.  She had a slight reaction to the two doses administered by the clinicians. A recent antibody test confirmed she was positive, meaning the vaccine had done its job giving her body the means to fight off Coronavirus.

"I wasn't concerned about receiving an experimental drug," Elle says. "In spite of political and market pressure, I can't see pharmaceutical companies blowing up their reputations by pushing forward with a vaccine that's dangerous to humans."

Ongoing trials for other Coronavirus drugs still need volunteers. Online screening surveys are available for those who wish to participate.  Compensation varies based on the vaccine trial you enter.  Some drug firms offer pay for travel and time involved with participating. 

However, most volunteers don't raise their hands for the money.  They view their participation as a noble calling and a selfless way to perhaps spare lives that otherwise may be taken by Coronavirus. Every American might pause this week to give thanks for these heroic volunteers.   

When the vaccine arrives soon, a grateful nation should celebrate Jen, Ian, Sophia and Elle along with the thousands of other fearless trial volunteers who made mass inoculation possible.  

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