I volunteered for a COVID-19 vaccine trial in New Jersey. Here's what it's been like since the shot.
On the afternoon of September 22nd, I became a data point looking for a vaccine against COVID-19.
At that point, I received the first of two shots in a clinical trial to develop a vaccine and became one of 30,000 volunteers who took a needle prick for science.
Why do I do this? 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 who supplied her with the injection, no one knows if I got a placebo or the possible vaccine. Not me. Not even Dr. Bindu Balani, the lead researcher in the study at Hackensack University Medical Center, one of 89 study sites across the country.
This is called a double-blind study because both the researchers and the participants are blind to what was in that syringe.
I admit I have a clue. But I won't share in case the team monitoring me reads this.
The tested vaccine was developed as part of the American Operation Warp Speed by ModernaTX, a ten-year-old biotech company from Cambridge, Massachusetts. Moderna has raised $ 955 million in government funding for the project, even though a vaccine has never been launched. If this vaccine is found to be safe and effective, the federal government has agreed to purchase 100 million doses with an option for an additional 400 million.
For seven days after my injection, I took my temperature every night, measured the size of the mosquito bite-sized bump on my arm as it faded, and noticed that my arm hurt a little at first, but "not enough to affect daily activities." "I recorded this and other information - including my lack of headaches, fatigue, muscle aches and nausea - in a secure phone app that sends the data to Moderna.
Weighing the pros and cons
My journey to the curtain booth where I received the first injection started while I was at work. I'm a health reporter and covered the pandemic for six months writing a story of clinical trials for the vaccine from New Jersey.
I wanted to do something to help and was intrigued by how a vaccine could be developed and brought to market so quickly in the midst of a pandemic. I thought a first person account of what it's like to be a guinea pig these days might be a good story.
That's why I completed an online questionnaire expressing my interest in volunteering. A few weeks later a nurse called.
Their enthusiasm was contagious. She and other nurses volunteered to recruit volunteers over the weekend, she said. She looked forward to being part of a project to end the pandemic.
The odds were between 50 and 50. I knew I was going to get a placebo, so no harm. If I got a vaccine and it was approved, I was ahead of the game. But when I got the vaccine and it wasn't approved, I would pause.
These were my doubts: after receiving a vaccine that failed the cut, could I still get an approved vaccine or could the two interact in harmful ways in my body? And if I had got COVID-19, could the test vaccine I received possibly cause an overreaction in my immune system and make a potentially mild case more serious?
When I told the nurse I had questions, Dr. Balani back.
There isn't enough data to answer these questions, she told me. I could 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 a healthcare writer, I spent months reporting on the devastation coronavirus wrought in New Jersey, from finding hospital beds to incalculable loss of life. I've experienced more grief and fear in seven months than in my last 40 years of reporting combined. Helping me find a vaccine felt like a small act of defiance and a personal expression of hope.
I was also interested in science and its translation into public health: the breakneck pace, the breakthroughs in understanding, the sheer magnitude of the logistics involved in manufacturing and distributing vaccines to an entire nation, let alone the world.
It feels historic, like the Manhattan Project - arguably the last time the US government, academia, and industry worked together on such a scale. I inherited the feeling from my father, who worked as a nuclear scientist in Hanford, the former Manhattan Project outpost in Washington state, that science can change the world.
I have decided.
On the day of my appointment, I read and signed the 22-page consent form. Balani took my medical history, gave me a physical one, and wiped me down 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 is based on a new method of generating an immune response in the recipient. It uses messenger RNA (mRNA), a component of cells that carries genetic information to cause the body to produce coronavirus antigens, thereby stimulating the immune system. Unlike previous vaccines against other diseases, the entire virus is not used live or inactivated.
Moderna's first human testing of the vaccine - Phase 1 - had 45 participants. Phase 2 had 600. I'm in phase 3.
Phase 1 recipients developed a good immune response to the disease - many 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 the vaccine reported serious adverse events after the second dose, including a man with a high fever who vomited and passed out the following day.
A nurse prepares a shot in July as a trial of a potential COVID-19 vaccine developed by the National Institutes of Health and Moderna Inc. begins in Binghamton, NY. On Tuesday, top executives at nine drug companies likely to make the first vaccines against the new coronavirus said they will test and manufacture to the highest ethical and scientific standards and make vaccinees' welfare their top priority.
This dose was 2½ times the dose my experimental group received. It was set to a lower, more tolerable level for phase 3.
Moderna did not report if anyone developed COVID after receiving the vaccine.
This question - whether the vaccine actually prevents its recipients from developing COVID-19 - is to be answered by the phase 3 study that began in late July. We volunteers should receive two injections of 100 milligrams each, 28 days apart. Half of us get a placebo - salt water - and half get the original.
So far, Moderna has recruited 28,043 participants. More than 19,000 have already received their second dose.
We are monitored to see if we develop COVID-19 and, if so, how seriously we get sick and whether we need to be hospitalized.
Once 53 people have a confirmed diagnosis of COVID-19, the sponsors - and an independent external advisory group known as the "data and security monitoring agency" - will conduct the first interim assessment to compare how many people are living with and without the vaccine got infected. Another evaluation is planned after 105 cases among the participants, and the final evaluation should be done after 151 cases. The security monitoring will then continue for some time.
The vaccine is considered effective if it reduces the risk of developing COVID by 60 percent - that is, if six out of ten recipients are prevented from developing COVID-19. (The flu vaccine is generally 40% to 60% effective.) Moderna may ask the federal food and drug control agency for an emergency approval or the EEA if evidence of effectiveness and safety is strong after the first interim assessment.
Moderna CEO Stéphane Bancel said on October 1 that the company would not be able to apply for an EUA until November 25 at the earliest, provided the security data is good.
Emergency clearance is more flexible than full FDA vaccine approval. The last few months have shown how it can be politicized. At the start of the pandemic, President Trump received an EEA after promoting the use of hydroxychloroquine to treat COVID-19 patients. It was later repealed when studies showed it was ineffective and, in certain cases, could cause harm.
The president announced an EEA for convalescent plasma, the high-antibody serum extracted from the blood of COVID-19 survivors, on the eve of the Republican National Convention, based on data that some experts believe was shaky.
It takes years to obtain full approval of the vaccine, which requires long-term safety monitoring.
The Moderna study is expected to last 25 months. After my second admission, I will make four more visits to the clinic, enter data into the phone app at various points and receive regular follow-up calls. The researchers will monitor us for side effects and harmful effects for two years.
In an unusual move, Moderna and Pfizer published their detailed study protocols in September. The obvious aim was to reassure the public in the face of concerns about political pressure over the scientific integrity of the process.
Slow down the research
To answer one question, I get a lot: Nobody will intentionally expose me to the virus as part of this study.
Dramatically higher risk is not part of the business. I don't intend to stroll unprotected through an intensive care unit for COVID patients. To be honest, I don't even plan to dine in a restaurant inside.
This caution, which experts say is shared by other subjects, may actually slow down research. The faster cases accumulate, the faster experts can determine if the vaccine is working.
Unfortunately for research science, people who volunteer for such studies tend to be better educated and healthier, said Dr. William Schaffner, Professor of Medicine at Vanderbilt University Medical Center and a 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 take a while for a sufficient number of infections to accumulate.
The public has not been fixated on the race for a vaccine since the polio epidemic. Who will get the first batches? How is it distributed? How effective will it be? How will the public accept that?
All of these questions remain unanswered. But I feel part of the story now.
I will let you know what happens.
Follow Lindy Washburn on Twitter: @lindywa
This article originally appeared on NorthJersey.com: Coronavirus: I'm part of a COVID-19 vaccine study in New Jersey
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