Monday, June 1, 2020

Volunteer Describes His Serious Reaction in Moderna’s mRNA COVID-19 Vaccine Trial

Volunteer Describes His Serious Reaction in Moderna’s mRNA COVID-19 Vaccine Trial


Of the 45 volunteers in biotechnology company Moderna, Inc.’s Phase 1 human clinical trial on its experimental mRNA-1273 vaccine for COVID-19, only the names of the first two participants have been widely publicized—Jennifer Haller of Seattle, Washington and Neal Browning of Bothell, Washington. The clinical trial began on Mar. 16, 2020 at Kaiser Permanente Washington Health Research Institute in Seattle, Washington. It has involved healthy adults 18 to 55 years of age. Haller
is 43 and Browning is 46.1 2 3
The name of another volunteer in the Moderna trial has now been made public after he gave interviews to CNN and CNBC.
Ian Haydon, 29, of  Seattle has spoken out about the severe adverse reactions he suffered 12 hours after receiving the second of two doses of the mRNA-1273 vaccine.4 Hayden is one of four participants who had Grade 3 reactions to the vaccine and one of three who experienced Grade 3 “systemic symptoms” after getting a second dose of 250 µg of the vaccine. As noted in a recent article I wrote for The Vaccine Reaction:
The U.S. Department of Health and Human Services (HHS) describes a Grade 3 adverse event as “severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care” such as “bathing, dressing and undressing, feeding self, using the toilet, taking medications.”5 6
Haydon said he came down with a fever of over 103 degrees and that he felt sicker than he ever has before. He sought medical care at an urgent care center. After he was released from the center and returned home, he fainted. Haydon noted he had previously hesitated to talk about his reactions to the experimental COVID-19 vaccine out of “an abundance of caution.”4
“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,” Haydon said.4 He added:
As we rush to get a vaccine developed as quickly as possible, the reality of vaccine development is that it can only be rushed so much and the trial still needs to take place. They have to move at the speed they move at. And stories like what happened to me, they matter because they shape the approval process.4
According to William Schaffner, MD, professor of preventive medicine and infectious diseases at Vanderbilt University Medical Center, Haydon’s reactions to the mRNA-1273 vaccine are “noteworthy,” but  that it doesn’t “stop the train,” suggesting research and development of Moderna’s mRNA vaccine would continue full speed ahead.4 7
Try as one might to downplay Haydon’s adverse reactions and those of the other three participants in the Moderna trial, these were severe reactions. What is noteworthy is that nine percent of the participants experienced these reactions. Imagine what this would mean were this vaccine to be given to tens of millions of people living in the U.S.
Also noteworthy is that the only thing worse than a Grade 3 adverse event are Grade 4 and Grade 5 events. Grade 4 is “life-threatening” and Grade 5 is “death.”5 6

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