A health journalist is getting a front-row seat to one of the most-anticipated pediatric trials in history.
The day after my teenagers got their first shots in the Moderna Covid vaccine trial, I found my 13-year-old daughter, Zoe, sprawled out in bed during a distance-learning art class. Under a pile of blankets, she said she had chills. My heart skipped a beat. Any other time I would have worried about her missing school or Nordic ski practice, but this time I was elated when her temperature peaked at 100.5 degrees.
A fever meant she was probably reacting to a real mRNA vaccine, and not a placebo. Maybe she’d won the vaccine lottery!
When Pfizer and Moderna were granted emergency authorization to license their vaccines in December, the shots were approved for people as young as 16 and 18, respectively. But in order to end the pandemic, many experts said that younger children will need to be vaccinated[1].
The adolescent Covid vaccine trials, for kids 12 to 18, got off to slow starts[2], in part because they took a while to find participants — Pfizer didn’t fill its 2,259 slots until late January and Moderna is still screening applicants to fill its 3,000 spots[3]. These trials also may require more months of data to complete (perversely, as infection rates decrease, it will take longer for enough teens to become infected to see how the vaccines perform; plus kids may contract the virus less frequently[4] than adults).
AstraZeneca, Johnson & Johnson and Novavax, whose vaccines aren’t licensed in the United States for adults yet, haven’t begun testing in children. Still, Moderna is hoping[5] adolescents can at least start getting vaccinated before the beginning of the next school year.
“We are on track to provide updated data around midyear 2021,” said Colleen Hussey, a Moderna spokeswoman. If the adolescent data looks similar to the adult results, then the company could apply for emergency use authorization for the 12 to 18 age group — potentially getting shots in arms before school starts in the fall.
But that seems unlikely for younger kids, whose testing hasn’t even started. Hussey said the company plans to test kids under 12 at progressively younger ages down to 6 months. But the company hasn’t pinpointed when that will begin beyond “sometime in 2021,” and Moderna’s chief executive, Stéphane Bancel, has said data from that study most likely wouldn’t be available until 2022.
My family has been eager to sign up for a trial, which would offer us a shot at early immunity and a chance to be a part of a historic moment in science. So, when a representative from the Moderna trial called to ask if my kids, Wes and Zoe, would like to participate, they quickly became subjects number 56 and 57.
Getting the shot
On a gray January afternoon, we were ushered into a gray exam room in downtown Minneapolis to learn the details of participating. A research coordinator explained that Moderna would pay the kids $75 per office visit and $30 per week for diary entries about their symptoms, which could total more than $1,000 over 13 months.
Sullivan explained the known risks of side effects from the vaccine, and Wes and Zoe’s enthusiasm only dwindled when she described the multiple nasal swabs and blood draws they were agreeing to (up to four of each over the course of six visits). But, buoyed by the possibility of being able to see their friends safely and, in the case of my son, upgrading his AirPods, they rolled up their sleeves.
Wes, looked like he was going to pass out during the blood sample draw, so the woman with the syringe, Karla McBrady, kept up an upbeat chatter: “I just want to say thank you for doing this! You may not even realize how much this is helping other people.”
Clinical trials typically begin with adult subjects, because they can give informed consent and serious side effects can be identified before kids are tested. Researchers also like to test vaccines on various ages separately because some aren’t safe or don’t work in younger people, said Dr. Robert Jacobson, a pediatrician and medical director of the Mayo Clinic’s Primary Care Immunization Program in Rochester, Minn. For example, the M.M.R. (measles, mumps and rubella), chickenpox and hepatitis A vaccines do not work well in those under 12 months, and the flu shot doesn’t work in babies under 6 months.
By testing increasingly younger ages, researchers hope to determine whether side effects play out similarly in adolescents and whether the vaccine reaches the same 95 percent efficacy in kids that it does in adults. That seems likely, given “the generally healthy and robust immune response in children 12 to 16 years old,” said Dr. Jill Weatherhead, an assistant professor of infectious disease at Baylor College of Medicine in Houston.
For the Covid vaccine, the most serious side effects have been severe allergic reactions (just 10 cases of anaphylaxis were detected[6] out of 4,041,396 first doses of the Moderna vaccine, nine of which occurred in people who had known allergies). That’s a risk we were willing to take, but even seemingly small risks aren’t for everyone, Dr. Jacobson noted.
For Wes and Zoe, the shot itself was anticlimactic; even needle-averse Wes said it hardly hurt. Still, since most allergic reactions can occur within 30 minutes of a shot, we had to wait around for an hour afterward.
“If you’re going to have an allergic reaction, the best place to have it is in a research facility,” Dr. Jacobson said.
Like all kids in the current trial, Wes and Zoe got the same dose as adults, which is typical for Phase 3 clinical trials, Dr. Weatherhead said. But when Moderna starts testing their vaccine on younger kids, researchers will use a lower dose, Hussey said. It’s very unusual to change the dose without starting over at Phase 1, Dr. Weatherhead said, but added, “As we have seen with the development of the adult vaccines, there are steps that can occur simultaneously and steps that can be accelerated to get to the end point of a safe and efficacious vaccine earlier.”
Crossing our fingers for a rash
For the next seven days, Wes and Zoe answered questions in their online diaries about any pain, achiness, swelling, fevers or fatigue they experienced. Unlike most adult Covid vaccine trials, which favor participants who regularly come into contact with people outside their households, Moderna had no instructions for us on changing our lifestyle. So life returned to distance learning and socially-distant ski practice.
Then, on day seven, my phone buzzed with a text from a friend whose son had participated in the trial the same day we had: “So, Zach has a rash around his injection site.”
I pushed aside my instinctive jealousy (we had promised to remain friends even if one of our families got stuck with the placebo). The next evening, I heard some excitement upstairs that made me set aside my book: Wes had discovered a similar red splotch on his arm. Gleefully, we measured the rash to report to our coordinator.
Even if it turns out that one or both of my kids got the saltwater placebo, which is given to one third of the participants in the teen trial, none of us will regret signing up. When I asked Drs. Weatherhead and Jacobson if they would sign their kids up, they said they would not hesitate.
“My firstborn got an experimental Hib vaccine in ’86 when he was 18 months old,” Dr. Jacobson said, referring to a vaccine that wiped out a bacterial infection that can cause meningitis. His younger son got it at 1 month. “I think it’s like donating blood; this is one of the great contributions a family can make.”
Moderna hasn’t said when or if they will reveal who got the placebo, but based on how company handled the adult trials, we are hoping Wes and Zoe will find out after data is released in the next few months. Adult participants who were given placebos have been offered the real vaccine.
I asked my kids what they would do with that ultimate prize. Visiting vaccinated grandparents and seeing friends indoors are high on their lists. While experts are wary of encouraging people to deviate too much from the standard precautions of mask-wearing and social distancing, even after vaccination, becoming subjects 56 and 57 has made those dreams seem a little closer for Wes and Zoe.
Sheila Mulrooney Eldred is a health journalist in Minneapolis.
References
- ^ will need to be vaccinated (www.nejm.org)
- ^ got off to slow starts (www.nytimes.com)
- ^ fill its 3,000 spots (clinicaltrials.gov)
- ^ contract the virus less frequently (https://ift.tt/fWVIMs)
- ^ Moderna is hoping (www.nytimes.com)
- ^ 10 cases of anaphylaxis were detected (www.cdc.gov)
from NYT > Well https://ift.tt/3ao3BTW
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