On the afternoon of September 22, I made a point of knowledge in the search for a vaccine to save him COVID-19.
That’s when I won the first of two vaccines in a clinical trial to expand a vaccine and I was one of 30,000 volunteers who took a needle for science.
Why am I doing this? A mixture of altruism, interest and a sense of duty as a journalist, but about that later.
Apart from the nurse who injected me and the hospital pharmacy that gave you the injection, no one else knows if I won a placebo or the possible vaccine. Not me. Not even Dr. Bindu Balani, the lead researcher in the trial at Hackensack University Medical Center, one of 89 sites across the country.
This is called a double-blind test because researchers and participants don’t know what’s inside that syringe.
I confess, I have a hunch. But I probably don’t percentage it, in case the team watching me reads it.
The proven vaccine was developed as a component of THE’s Warp Speed operation. But it’s not the first time Through ModernaTX, a biotechnology company in Cambridge, Massachusetts. Moderna earned $955 million in government investments for the project, never brought a vaccine to market. If this vaccine is safe and effective, the federal government is committed to purchasing one hundred million doses, with the option of a build-up of 400 million.
Seven days after my injection, I took the temperature every night, measured the length of the hump the length of a mosquito bite on my arm when I disappeared, and saw that at first my arm hurt a little, but “not enough to daily activities. “I recorded this and other data, adding my absence of headaches, fatigue, muscle pain and nausea, in a safe phone app that sends knowledge to Moderna.
Why did I do that?
My adventure in the curtain booth where I won the first injection at work. I’m a fitness reporter who’s been covering the pandemic for six months when I wrote an article about clinical trials of the vaccine in New Jersey.
I wanted to do anything to help and I was fascinated by how a vaccine can evolve and advertise so temporarily in the middle of a pandemic. I have the idea of a first-person account of what it’s like to be a guinea pig in those days. make a smart story.
So I filled out an online questionnaire pointing out my interest in volunteering. A few weeks later, a nurse tracked a phone call. “Always interested?” She asked.
His contagious enthusiasm. She and other nurses had volunteered to paint weekends to recruit volunteers, she said. I was extremely happy to be part of a task to end the pandemic.
Now that I’ve been accepted, I had to face a big resolution, whether I’d stick to it or not.
I read about Moderna, researched the media policy of vaccine trials, and weighed the cons.
The odds were 50-50 that I’d get a placebo, I knew, so there wouldn’t be any damage. If I was given a vaccine and approved, I was moving forward in the game. But if I was given the vaccine and I wasn’t approved, it made me think.
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These were my doubts: after receiving a vaccine that did not make the cut, can I continue to get an approved vaccine, or can the two interact destructively in my body?What if I won COVID-19, it is possible that the control vaccine I won could cause an exaggerated reaction in my immune formula and worsen a potentially mild case?
When I told the nurse I had questions, Dr. Balani answered me.
There’s not enough knowledge to answer those questions, he tells me. I lost retiring at any time before the scheduled exam to finish in 25 months. If any other vaccines were approved and I sought to get it, she would ask me to “lift the blind” from my state. If I got sick, they’d touch my doctors.
There were also other points to consider. As a fitness editor, I’ve been reporting for months on the devastation caused by coronavirus in New Jersey, from rushing through hospital beds to the incalculable loss of human life. I’ve witnessed more pain and worry in seven months than I did in my 40s. years of combined reports. Participation in the search for a vaccine was felt as a small act of defiance and an expression of non-public hope.
In addition, I was interested in science and its translation into public health: the frantic pace, the advances in understanding, the enormous scale of logistics to produce and distribute vaccines to an entire nation, not to mention the world.
This is historic, like the Manhattan Project, the last time the U. S. government was able to do so. In the U. S. , science and industry worked in combination on such a scale. I inherited the feeling that science can replace my father’s global, who worked as a nuclear scientist in Hanford. , the former outpost of the Manhattan Project in Washington state.
So I’m leaving.
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On the day of my appointment, I read and signed the 22-page consent form. Balani took my medical history, did a physical exam and rubbed me to see if I had an active COVID-19 infection. A nurse took my important symptoms and 8 vials of blood. I downloaded the app and learned how to use it.
The injection into my right arm is quick and easy.
I had a statistic.
Moderna’s vaccine is in a new approach to generating an immune reaction in the receptor: it uses messenger RNA (mRNA), a component of cells that transmits genetic information, to cause the framework to produce coronavirus antigens and thus stimulate the immune system. vaccines for other diseases, does not use total, live or inactivated viruses.
The first trials of the Modern vaccine in humans – Phase 1 – had forty-five participants. Phase 2 had 600. I’m in phase 3.
Phase 1 receptors have developed an immune reaction opposed 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 other 14 people who won the highest dose of the vaccine reported serious side effects after the dose at the time, adding a guy who had a high fever, vomited and fainted the next day.
This dose is 21. 2 times higher than the dose my test organization receives and was set at a more tolerable and decreasing point for phase 3.
Moderna did not imply whether COVID had evolved after receiving the vaccine.
This question, if the vaccine prevents its receptors from presenting COVID-19, wants to be answered through the Phase 3 trial, which began last July. Volunteers deserve to receive two injections of one hundred micrograms each, 28 days apart. Half of us get a placebo, salt water, and the other part, the real one.
To date, Moderna has recruited 28,043 participants. More than 19,000 have already won their doses.
Research sites, such as Hackensack and Rutgers New Jersey Medical School at Newark University Hospital, are looking to have participants who pose the greatest threat to COVID. About a third are from “diverse communities,” the company said.
The two sites in New Jersey still host volunteers to participate.
They will follow us to see if we expand COVID-19 and, if we do, how seriously we are sick and whether we want to be hospitalized.
As soon as 53 other people get a proven diagnosis of COVID-19, promoters, and an independent third-party advisory organization called the “Data And Security Oversight Committee,” will make the first mid-term assessment to compare the number of other people with and without it. . vaccine, has been infected. Another evaluation is scheduled after 105 instances among participants, and the final evaluation will be conducted after 151 instances. Security tracking will continue for some time after this.
The vaccine will be considered effective if it reduces the threat of COVID by 60%, i. e. if it prevents six out of 10 recipients from having COVID-19 (the flu vaccine is 40-60 effective). Modern would possibly ask the Federal Food and Drug Administration for emergency use authorization, or the U. S. , if there is strong evidence of efficacy and protection after the first mid-term evaluation.
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Modern CEO Stéphane Bancel said on October 1 that the company can apply for an U. S. until November 25, assuming safety knowledge is good.
An emergency use authorization is more flexible than full FDA approval of a vaccine. The last few months have shown how it can be politicized. At the beginning of the pandemic, after President Donald Trump promoted the use of hydroxychloroquine to treat COVID patients on October 19, he won an OAS, which was then canceled when studies proved useless and could, in some cases, cause harm.
The president also announced a U. S. for convalescence plasma, the antibody-rich serum extracted from the blood of COVID-19 survivors on the eve of the Republican National Convention, based on knowledge that some experts are unstable.
Full approval of the vaccine, which requires long-term protection control, takes years.
The Moderna is designed to last 25 months. After taking my moment, I will make 4 more visits to the clinic, enter my knowledge in the phone app at other times and get regular follow-up phone calls. Researchers will monitor us for side effects and destructive effects for two years.
Modern and Pfizer published their detailed examination protocols in September. The obvious goal was to reassure the public about the clinical integrity of the procedure, without considering political pressures.
The protocol described the dangers and participants and concluded that, in the face of the danger of contracting COVID-19, the existing lack of vaccine and clinical evidence to date”, the prospect of participation
To answer a question, I get a lot: no one will intentionally disclose the virus to me in this study. The UK is the only country in this type of “challenge” trial in healthy young adults.
A top component threat is not a component of the agreement. I do not intend to walk unsyged in an extensive care unit for COVID patients. To be honest, I don’t even plan to dine inside a restaurant.
This warning, which experts say is shared through other volunteers in the trial, would possibly slow down the search; The faster the instances accumulate, the faster experts can see if the vaccine is working.
“Unfortunately for science studies, other people who volunteer for studies like this tend to have more knowledge and be more health-oriented,” said Dr. William Schaffner, a professor of medicine at Vanderbilt University Medical Center and a member of the Advisory Committee. in the center’s immunization practices, for prevention and disease. As a result, they are more likely to protect themselves from COVID-19, which means it will be some time before a sufficient number of infections accumulate.
“Some of those tests may last longer than expected,” he said, “because volunteers “stay home, wear masks, distance the the most socially [and] don’t pass out in bars. “
Since the polio epidemic, the public has not been more obsessed with the vaccine race Who will get the first batches?How will it be distributed?
All those unanswered questions. But now I feel like I’m a component of history.
I’ll let you know what’s going on.
Lindy Washburn is a senior fitness reporter for NorthJersey. com. To stay on top of changes in the medical world in your fitness and that of your family, subscribe or activate your virtual account today.
Email: washburn@northjersey. com Twitter: @lindywa