On the afternoon of Sept. 22, I became a data point in the search for a vaccine to prevent COVID-19.
That’s when I received the first of two shots in a clinical trial to develop a vaccine, and became one of 30,000 volunteers to take a needlestick for science.
Why am I doing it? A combination of altruism, curiosity, and a sense of duty as a journalist. But more on that later.
Aside from the nurse who injected me and the hospital pharmacy that supplied her with the injection, no one else knows whether I received a placebo or the would-be vaccine. Not me. Not even Dr. Bindu Balani, the principal investigator in the trial at Hackensack University Medical Center, one of 89 study sites around the country.
This is called a double-blind study because both the researchers and the participants are blind to what was inside that syringe.
I admit, I have a hunch. But I won’t share it, in case the team monitoring me reads this.
A participant in Moderna’s clinical trial of a vaccine for COVID-19 receives an injection. Half of the participants received the vaccine, and half received a placebo. (Photo: Lindy Washburn)
The vaccine being tested was developed as part of America’s Operation Warp Speed by ModernaTX, a decade-old Cambridge, Massachusetts biotech company. Moderna has been awarded $955 million in government funding for the project, although it has never brought a vaccine to market. If this vaccine is shown to be safe and effective, the federal government has contracted to buy 100 million doses, with an option for 400 million more.
For seven days after my injection, I took my temperature each evening, measured the size of the mosquito-bite-sized bump on my arm as it faded away, and noted that at first my arm hurt a little, but “not enough to affect daily activities.” I recorded this and other information — including my lack of headaches, fatigue, muscle aches and nausea — on a secure phone app that sends the data to Moderna.
Weighing the pros and cons
My journey to the curtained cubicle where I received the first injection began on the job. I’m a health care reporter, and I had been covering the pandemic for six months when I wrote a story about clinical trials for the vaccine starting in New Jersey.
I wanted to do something to help, and was fascinated by how a vaccine could be developed and brought to market so rapidly amid a pandemic. I thought a first-person account of what it’s like to be a guinea pig these days might make a good story.
So I completed an online questionnaire declaring my interest in volunteering. A few weeks later, a nurse followed up with a phone call.
Her enthusiasm was contagious. She and other nurses had volunteered to work weekends to recruit volunteers, she said. She was excited to be part of a project to bring an end to the pandemic.
Chances were 50-50 I’d get a placebo, I knew, so no harm there. If I did get a vaccine and it was approved, I was ahead of the game. But if I got the vaccine and it was not approved — that made me pause.
These were my doubts: After having received a vaccine that didn’t make the cut, could I still get an approved vaccine, or might the two interact in harmful ways in my body? And if I did get COVID-19, could the test vaccine I received potentially cause an over-reaction in my immune system and make a potentially mild case more severe?
When I told the nurse I had questions, Dr. Balani called me back.
There isn’t enough data to answer those questions, she told me. I was free to withdraw at any time before the planned end of the study in 25 months. If another vaccine was approved and I wanted to get it, she would ask to “unblind” my status. If I got sick, they would communicate with my doctors.
There were other factors to consider as well. As a health care writer, I’d been reporting for months about the devastation coronavirus has wrought in New Jersey, from the scramble for hospital beds to the incalculable loss of life. I witnessed more grief and fear in seven months than in my prior 40 years of reporting combined. Assisting in the research for a vaccine felt like a small act of defiance and a personal expression of hope.
Plus, I was interested in the science and its translation to public health: The breakneck pace, the breakthroughs in understanding, the sheer magnitude of the logistics to produce and distribute vaccines to an entire nation, let alone the world.
It feels historic, like the Manhattan Project — arguably the last time the U.S. government, science and industry worked together on such a scale. I’d inherited a sense that science can change the world from my father, who worked as a nuclear scientist at Hanford, the Manhattan Project’s former outpost in Washington State.
I decided to go for it.
The day of my appointment, I read and signed the 22-page consent form. Balani took my medical history, gave me a physical and swabbed me to see if I had an active COVID-19 infection. A nurse took my vital signs and eight vials of blood. I downloaded the app and learned how to use it.
The injection into my right arm was quick and easy.
I had become a statistic.
How the vaccine would work
Moderna’s vaccine relies on a new method of generating an immune response in the recipient. It uses messenger RNA (mRNA), a component of cells that transmits genetic information, to cause the body to produce coronavirus antigens and thus stimulate the immune system. Unlike previous vaccines for other illnesses, it doesn’t use whole virus, either live or inactivated.
Moderna’s first tests of the vaccine on humans — Phase 1 — had 45 participants. Phase 2 had 600. I’m in Phase 3.
The Phase 1 recipients developed a good immune response against the disease — lots of antibodies — according to a report published in the New England Journal of Medicine.
Three dose sizes were tested to determine which was best. Three of the 14 people who received the highest dose of vaccine reported severe adverse events after the second dose, including one man who had a high fever, vomited, and fainted the following day.
A nurse prepares a shot in July as a study of a possible COVID-19 vaccine, developed by the National Institutes of Health and Moderna Inc., gets underway in Binghamton, N.Y. On Tuesday, the top executives of nine drugmakers likely to produce the first vaccines against the new coronavirus said that they will stick to the highest ethical and scientific standards in testing and manufacturing and will make the well-being of those getting vaccinated their top priority. (Photo: HANS PENNINK/THE ASSOCIATED PRESS)
That dose was 2½ times the dose my trial group receives. It was set at a lower, more tolerable level for Phase 3.
Moderna hasn’t reported whether anyone developed COVID after receiving the vaccine.
That question — whether the vaccine actually prevents its recipients from developing COVID-19 — is to be answered by the Phase 3 trial, which started in late July. We volunteers are to receive two injections of 100 milligrams each, 28 days apart. Half of us get a placebo — salt water — and half get the real thing.
So far, Moderna has recruited 28,043 participants. More than 19,000 have already received their second dose.
We’ll be followed to see if we develop COVID-19, and if we do, how severely ill we become and whether we need to be hospitalized.
As soon as 53 people receive confirmed diagnoses of COVID-19, the sponsors — and an independent, external advisory group called a “data and safety monitoring board” — will do the first, interim assessment to compare how many people with and without the vaccine became infected. Another assessment is planned after 105 cases among participants, and the final assessment is to come after 151 cases. Safety monitoring will go on for some time after that.
The vaccine will be considered effective if it reduces the risk of getting COVID by 60 percent — that is, if it prevents six out of 10 recipients from developing COVID-19. (The flu vaccine generally is 40% to 60% effective.) Moderna may ask the federal Food and Drug Administration for an emergency use authorization, or EUA, if the evidence of efficacy and safety is strong after the first interim assessment.
Moderna’s CEO, Stéphane Bancel, said Oct. 1 that the earliest the company could apply for an EUA would be Nov. 25, assuming the safety data was good.
An Emergency Use Authorization is more flexible than full vaccine approval by the FDA. Recent months have shown how it can be politicized. Early in the pandemic, after President Trump touted the use of hydroxychloroquine to treat COVID-19 patients, it received an EUA. It was later rescinded when studies showed it was ineffective and could in certain cases cause harm.
The president also announced an EUA for convalescent plasma, the antibody-rich serum extracted from the blood of COVID-19 survivors, on the eve of the Republican National Convention, based on data that some experts say was shaky.
Full vaccine approval, which requires long-term safety monitoring, takes years.
The Moderna study is designed to take 25 months. After my second shot, I’ll make four more visits to the clinic, enter data into the phone app at various points, and receive regular follow-up phone calls. Researchers will monitor us for side effects and harmful outcomes for two years.
In an unusual step, Moderna and Pfizer released their detailed study protocols in September. The apparent goal was to reassure the public about the scientific integrity of the process, in light of concerns about political pressure.
Slowing the research
To answer one question I get a lot: No one will deliberately expose me to the virus as part of this study.
Dramatically higher risk is not part of the deal. I have no plans to stroll unprotected through an intensive care unit for COVID patients. To be honest, I don’t even plan to dine indoors at a restaurant.
That caution, which experts say is shared by other trial volunteers, may actually slow the research; the faster that cases accumulate, the faster experts can see whether the vaccine works.
Unfortunately for research science, people who volunteer for studies like this tend to be better educated and more health-oriented, said Dr. William Schaffner, a professor of medicine at Vanderbilt University Medical Center and member of the Advisory Committee on Immunization Practices at the Centers for Disease Control and Prevention.
They are therefore more likely to protect themselves from COVID-19, which means it will be a while before a sufficient number of infections piles up.
Not since the polio epidemic has the public been more fixated on the race for a vaccine. Who will get the first batches? How it will be distributed? How effective will it be? How will the public accept it?
All these questions remain unanswered. But I feel like I’m part of history now.
I’ll let you know what happens.
Follow Lindy Washburn on Twitter: @lindywa
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