June 3, 2021
by The Biring Family, featuring ninth grader Devneet and eighth grader Navreen!
COVID-19 has forever changed our world. What began as a scary unknown more than 18 months ago has now been largely conquered by vaccines that have given our country and the rest of the world a fighting chance to defeat this virus. The first vaccines against COVID-19 were approved for use in adults (and people ages 16 and above in the case of the Pfizer-BioNTech vaccine) in December 2020 with initial vaccines being given to high-risk groups including healthcare workers and elderly patients.
When our kids first found out that the vaccines had received emergency use authorization, they were excited! But that excitement quickly abated when they realized that vaccinations for younger populations were not likely to be available until at least the summer. Devneet and Navreen asked why would it take so long for them to get vaccinated, and we explained that there would need to be trials in the younger populations before the vaccines would be given to children. At that time, there were reports that it was difficult to get the necessary recruitment numbers for trials in children. Devneet and Navreen asked us if there was any possibility that they could be part of a trial. As vaccine rollouts continued in adults, both Pfizer-BioNTech and Moderna vaccine trial recruitments were underway for younger populations in various cities across the country. We found out that one of the city sites for the Moderna adolescent study was Minneapolis, and we inquired about details of the study.
Moderna began enrolling adolescents, ages 12-17, in a Phase 3 trial across the United States to evaluate the efficacy and safety of their COVID-19 vaccine. The trial is comprised of 3000 adolescents in a blinded study with 2/3 of volunteers receiving vaccine and 1/3 receiving placebo. This 13-month trial requires five clinic visits with two injections (at the initial appointment and one month later), four blood draws, four nasopharyngeal swabs, and electronic diary submissions. The trial will end in the spring of 2022.
MPA ninth grader Devneet:
“Having the chance to be in a vaccine trial with 3000 adolescents across the country was cool because I knew that I was one of those people making a difference in our vaccine process. After feeling like all I could do was socially distance and wear masks for the last year, it felt like I could finally do something that could help end this pandemic. It was neat to be a part of science!”
MPA eighth grader Navreen:
“In late 2020 to early 2021, I remember being curious about COVID-19 vaccines and when they would become available for adolescents in the United States. Additionally, I was interested in why the vaccine trials for adolescents did not have an adequate number of participants, so I asked my parents if they could enroll me in one. I knew that if there were not enough adolescents in the study, then it would take longer for the COVID-19 vaccine to be distributed to minors in general. So, I asked my parents to find out if there were trials in our area and if I could take part in it. My mom found out that there was a trial starting in Minneapolis, and I was enrolled in the Moderna COVID-19 Vaccine Trial for Adolescents (ages 12-17)! Wanting to return to a sense of “normal,” and wanting to visit family I had not seen in a long time, I was extremely excited when my mom told me I was in!”
Devneet and Navreen enrolled in the Moderna vaccine trial in January 2021. Each of them received their first injections at their first appointment on February 15, 2021. This first appointment lasted about 3.5 hours and included an in-person history and physical exam as well as a blood draw, a nasopharyngeal swab to rule out COVID-19 infection, an injection, and then a one-hour on-site observation period with entry into their respective e-diaries. Questions in the e-diary (Medi-data) included pain/swelling/redness at the injection site, achiness, swollen glands in the armpit, headaches, body aches, fatigue, sore throat, fever, chills, etc. Medi-data entries continued daily for one week after the first appointment. After one week, the clinical nurse coordinator called to review the Medi-data entries with us. Any changes in their health were documented.
“The first time I went to the clinical trial center, the nurse took my temperature, gave me a Covid test by doing the nose swab, took my blood, and finally gave me my first shot. We spent more than 3 hours at the center, and it was tiring. The nose swab was the worst because it was the first time that I had ever gotten tested for Covid in that way. It felt like the Q-tip was touching my brain, and it hurt for at least 5 minutes after getting the swab. After I got home, I felt no symptoms from the shot while my sister had a lot of symptoms. My first thought was, ‘Did I get the shot or was it the placebo? Or it could have been just that I was asymptomatic.’ We also had to download an app for our e-diary where we had to record data of how we felt after getting the shot.”
“The first appointment was the longest by far, it took around 3.5 hours! Much of it consisted of waiting. After my brother went first, the nurse took my blood and tested me for COVID-19 with a nasal swab. That was my first time getting a nasal swab and I almost wanted to sneeze. I felt like they pushed it in so far that it hit the very bottom of my throat. It was not terrible, just extremely uncomfortable. However, I dreaded the blood draws more than the nasal swabs. The sight of seeing and feeling the needle freaked me out. Later, someone came in with an injection and gave me a mini-physical. Finally, that person gave me a shot. I knew by then there was no way of knowing if I had the COVID-19 vaccine right away, so I would have to see how I felt as the day went on.
The clinical nurse coordinator asked my brother and me to download an app on our phones called Medi-data. She explained that our online e-diary entries would be done through there, and that any data we enter must be specifically related to the vaccine. We also had to wait an hour there before entering our first data entry. The entries went on for one week.
Hours after I got my first shot, my arm ached. That night, I took some Tylenol and it stopped for a while. I woke up the next morning and the same dull ache was still there. It felt like I had just gotten the flu shot again. At this point, I thought I had the COVID-19 vaccine, however; I knew I should wait until after the second shot to see if I was right.”
The kids’ second appointments and injections took place on March 15, 2021. Again, physical examinations and nasopharyngeal swabs were performed. There were no blood draws this time, and Devneet and Navreen were relieved. The kids again waited on-site for one hour after the injections so that the they could be observed for any immediate adverse reactions to injections. E-diary entries were also completed one hour after injections per study protocol. This appointment took about 2.5 hours. Medi-data entries continued daily for one week after the first appointment. After one week, the clinical nurse coordinator called to review the Medi-data entries with us and to review any other changes in their health.
“We had to wait four weeks to go back to the clinic for our second appointment. I received my second shot. We went through the same process except they did not take my blood this time and only did the swab and shot. After my second shot, I had a painful lump near my injection site right after I got the shot. After an hour, the lump disappeared. I also felt tired, but I was not sure if it was because my appointment was early in the morning. I went home and slept for a few hours, and the tired feeling was gone. I had no other symptoms after that. I recorded this information in my Medi-data app. ”
“As a whole,this appointment felt much shorter than the previous one because we had already made all future appointments, which made it run much faster. We first received another uncomfortable COVID-19 test and then the second shot.
This shot felt different compared to the first one. About 10-15 minutes after the shot, my arm started aching. At that moment, I was pretty sure I had gotten the vaccine. The arm aching worsened through the day, which I recorded in my Medi-data e-diary entry.
All throughout the rest of the day, my arm felt very sore. Then around dinnertime, I started having the chills. I had the chills for 30-60 minutes then went to sleep. After I woke up, my arm still ached and my chills stopped, but were replaced with a fever instead. My dad gave me Tylenol for the fever which helped; however; it came back once again later that night. I got another dose of Tylenol. By the next morning, the only symptom I still had was my arm aching.”
On April 19, Devneet and Navreen had their third appointments which lasted about 1.5 hours. This appointment included physical exams and blood draws. The kids continued with more Medi-data entries. The nurse also reviewed tentative next steps with regards to determining when we would find out who received the vaccine versus placebo. She had told us that Moderna would compile the Phase 3 data and apply for emergency use authorization for adolescents. Once approved (which was a 4-to-6-week process), the study would be unblinded and whoever had received the placebo would then be offered the vaccine. With regards to the study, the next two scheduled appointments would be in September 2021 and March 2022 until we received information regarding the emergency use authorization.
As we waited for news from Moderna regarding unblinding the study, the Pfizer-BioNTech vaccine received emergency use authorization for adolescents ages 12 to 15 on May 10, and vaccinations for this age group began shortly thereafter. On May 24, we learned that Moderna would not be seeking emergency use authorization for the vaccine until early summer, and the official unblinding of the study would take place mid to late summer. We decided that it was important to know the results as soon as possible because if either of the kids had received the placebo, we wanted them to get vaccinated as soon as possible. The kids were also anxious to know what they had received. That same morning (May 24), we requested unblinding of the study – knowing that if one of the kids received the placebo, the trial would be over for that person, and whoever received the vaccine could continue in the trial until next spring.
“When my mom picked us up from school that Monday, she told us that she had gotten the results of the vaccine trial. I had suspected that I had gotten the placebo, and my sister had received the vaccine. I was right. I wasn’t upset or disappointed because I was happy that I had volunteered to be one of the 3000 people in the trial. I knew that out of those 3000, some of us got the placebo. That same afternoon I received my first Pfizer-BioNTech vaccine at CVS. I was relieved to know the results so that I could I get my vaccine!”
“Both my brother and I were anxious to see if we had gotten the vaccine or not. My mom told me they would contact her 4-6 weeks after our third appointment, when Moderna would apply for emergency use authorization for adolescents.
In the car ride home from school one day, she told us the news. I had gotten the COVID-19 vaccine. I was not surprised that I had gotten it, as I had many of the common symptoms, but I was curious to see if my brother had it, too. He had not, so he went to CVS to get a Pfizer-BioNTech vaccine that same day. My mom told me I could continue the trial for the originally planned thirteen months which means two more appointments and more Medi-data entries. But I plan to continue.”
“I thought it was cool to be in a trial with 3000 people all across the country, and I also knew I be able to share about my experience with my friends and family wondering about the vaccine. Even though I received the placebo, I am happy that I was able to be a part of something that makes it easier for kids to get vaccinated.”
“When I had first volunteered for the trial, I did not know what to expect. Now, COVID-19 has turned my life upside down in the past year-and-a-half, and I have a unique perspective because of this trial. I am happy that I have had the opportunity to be a part of this trial and that I can continue to be a part of science for the rest of the thirteen months. And although I am sure many kids who may have wanted to do the trial may have thought it was not worth it to get the blood draws, nasal swabs, shots, etc. I believe that being a part of the trial was a wonderful way to help my community. I am hopeful for a future where we can all return to a sense of normalcy and go back to doing the things we love.”
We could not be prouder of Devneet and Navreen for embarking on this vaccine trial journey. Neither of them hesitated when they were told what the study would entail (blood draws, nasal swabs, time commitment, e-diary entries, etc). After observing the experience of her older siblings, our youngest child, Elina, is looking forward to participating in a trial in her age group. She is currently enrolled in the Phase 3 Moderna vaccine trial for ages 6-11, and we are awaiting details of when that study will begin. We are hoping as a family that we can continue to educate people about the importance of vaccination against COVID-19.
Amazing work, Panthers–you inspire us!