A trio of Denver siblings jockeyed with one another Monday to become the first kids in Colorado to receive the Novavax COVID-19 vaccine.
Twins Lucas and Emilia Vannoni, 12, and their older brother, Lorenzo Vannoni, 14, volunteered to participate in a clinical trial to test the Novavax COVID-19 vaccine on children and teens, ages 12 to 17.
Lucas and Emilia flipped a coin to determine who would get the first jab. Emilia made the case that she should go first since she was born minutes before Lucas. But, he won the toss. So, Emilia gamely held her brother’s hand since he’s not crazy about getting shots. Lucas got the first dose, high-fived his nurse and said it wasn’t very painful. Emilia followed and minutes later, Lorenzo got his first dose. All three then showed off their colorful Band-Aids and declared the shots to be no worse than a flu vaccine.
The Denver middle school students and their medical team at the University of Colorado Anschutz Medical Campus in Aurora won’t know for a few months whether each received the real vaccine or a placebo since the clinical trial is “blind,” meaning none of the participants knows who gets which dose (except for the pharmacist who fills up the syringes).
Do you want to participate in the University of Colorado Novavax Clinical Trial for children and teens?
Who is eligible? Children and teens ages 12 to 17. The team is eager to include young people of color.
Where? The study is taking place on the University of Colorado Anschutz Medical Campus in Aurora.
When? Now. Parents of interested children and teens should call or reach out to the team immediately. Most study participants will receive their first dose of the vaccine or placebo in the next couple of weeks.
How can I contact the study managers? Call 720-777-4496 or email Novavaxstudy@cuanschutz.edu
Even so, the Vannonis were excited to help advance knowledge about COVID-19 vaccines for children and teens.
“We all wanted to get vaccinated and get COVID over with,” said Lorenzo. “It’s super cool that we get to be part of developing a vaccine that hopefully will save lives.”
Their mom, Valentina Vannoni, said all three had been begging to participate in the clinical trial.
“We’re so excited. We’re so blessed,” she said when she learned that her children would be the first participants in Colorado to participate in the study.
Kids take their turn in clinical trials for COVID-19 vaccines
Along with helping researchers, the Vannonis had a good chance of getting the real vaccine. For most pediatric COVID-19 trials, two of every three participants will receive the real vaccine. (That’s a higher ratio than the adult clinical trials for COVID-19 vaccines. In those trials, 50% of people received real vaccines while 50% received placebo.)
The Vannoni twins and their brother also liked knowing they will get paid when they complete the study. Each has fun plans for the cash. Lorenzo is building a gaming system and hopes to buy a few parts he’s missing along with some games. Emilia is saving up for a new phone. And Lucas is a young man with big ideas. One of his dreams is to have a woodworking workshop in the garage.
Dr. Myron Levin, who is helping to oversee the Novavax clinical trial and some other pediatric clinical trials for COVID-19 vaccines, declined to say exactly how much each participant will receive because researchers don’t want to entice volunteers with cash. But, it’s customary to pay people — even kids — who participate in scientific research.
Levin is a pediatrician and a professor of pediatrics and infectious diseases at the University of Colorado School of Medicine. He has conducted clinical trials for decades and was part of the University of Colorado team that developed the first shingles vaccine in the U.S. While he has helped launch many clinical trials over the years — including some for COVID-19 vaccines for adults — the beginning of the Novavax pediatric study in Colorado felt particularly momentous and historic.
“I’m really excited. It’s important for the country and the world to have children vaccinated,” Levin said.
“First, it’s important for the children,” Levin said. “People think children cannot get sick from COVID-19, but many do. Some get hospitalized, some get an unusual autoimmune disease and there have been some deaths.”
Getting children and teens vaccinated also will greatly speed efforts to get children back in schools and back to fun summer activities.
“These vaccines are important for the children, but also for the rest of us. We need to bring this pandemic to a halt. If COVID-19 is still spreading among children, we won’t be able to end the pandemic quickly or easily,” Levin said.
How the study on Novavax COVID-19 vaccines for children and teens will work
The Vannonis arrived at a trailer east of Children’s Hospital Colorado on the Anschutz Medical Campus on Monday morning and signed several consent forms before providing detailed medical histories, getting tested for COVID-19 and getting their blood drawn.
Researchers will assess the Vannonis’ blood samples to determine if they already have any antibodies to the SARS-CoV2 virus, which causes COVID-19. The Vannonis don’t think that any family members ever had COVID-19, but the family was living in the United Kingdom during the beginning of the pandemic before returning to their home in Colorado. And some people — including both adults and children — get asymptomatic cases of COVID-19 without ever knowing they had it. So, it’s possible that the children could have some antibodies to the coronavirus.
Next, the Vannonis took turns receiving their doses of either the vaccine or the placebo. Then they downloaded apps to report any side effects they might experience after their jabs. All three will return for a second dose of vaccine or placebo in 21 days.
Once about six months has passed, study participants will be allowed to learn if they received the vaccine or the placebo. Those who received the placebo will be able to get a real vaccine.
Levin is also being very flexible with study participants since the Pfizer vaccine is expected to be authorized this week for children and teens ages 12 to 15. If participants in the Novavax study learn that they received the placebo instead of the Novavax vaccine, they could choose to exit the study and get the Pfizer vaccine instead.
“We’ll make accommodations to make sure everybody gets vaccines as soon as possible,” Levin said.
Cooperation among scientists and support for research on all effective vaccines is critical, he said.
“All of these studies are good for the country and we’ll be doing more pediatric clinical trials,” Levin said.
He and the Novavax study managers now are recruiting children and teens, ages 12 to 17. The clinical trial will fill up fast. Parents of children and teens who wish to participate should call 720-777-4496 or email the team managers at firstname.lastname@example.org as soon as possible.
How is Novavax different from Pfizer, Moderna and the Johnson & Johnson vaccines?
UCHealth researchers just finished Phase 3 of the Novavax trial for adults.
Levin said Novavax is a very good vaccine and he expects it to win approval in the U.S. soon for both adults and children. The vaccine is more similar to traditional vaccines. The manufacturer created spike proteins in the laboratory, then purified them and spike protein gets injected into patients.
“Novavax targets the same viral protein as all of the other vaccines, but it’s given with an adjuvant, which is a chemical that enhances the response,” Levin said. “It’s packaged in a form that makes it more visible to the immune system.”
The Novavax vaccine was shown to be very effective during clinical trials in the United Kingdom — about 90% effective in preventing disease.
“There’s excellent reason to think that it will work well for children. And there have not been any safety concerns,” Levin said.
The Moderna and Pfizer COVID-19 vaccines use a different method called mRNA. The mRNA molecule contains the genetic code for the spike protein. The person’s cells then take up the mRNA and start manufacturing the spike protein.
The Johnson & Johnson vaccine uses what’s known a disabled adenovirus, which is similar to a cold virus, to deliver the vaccine.
All of the vaccines for COVID-19 are proving to be remarkably effective, Levin said.
What will the Novavax COVID-19 trial determine?
The pediatric clinical trials for children and teens will be different from those that are being done for COVID-19 vaccines in adults.
Those trials were much larger, with either 30,000 or 45,000 volunteers enrolled in each of the adult COVID-19 clinical trials throughout the U.S.
In contrast, altogether across the U.S., scores of pediatric clinical trial sites across the U.S. will be enrolling about 2,200 children and teens in the Novavax study.
Levin and his team hope to enroll about 50 to 75 Colorado volunteers over the next couple of weeks.
“Once a vaccine is shown to be effective in a clinical trial, then the government often allows the vaccine maker to give it to another population, like children. To do that, you have to show that it’s safe in that other population and that it causes the same immune response seen in adults.” Levin said.
The process of moving to another population is known as “bridging.”
Novavax and other vaccine makers bridge to children by first testing their vaccines in a small “sentinel” population of about 75 children or teens. All of study participants received the vaccine and none had any adverse side effects.
The vaccines then were deemed to be safe for children and teens. The next step is giving vaccines to a larger group in the new population — in this case, children and teens ages 12 to 17. At this stage, researchers will determine whether the vaccines generate similar immune responses in young people as they do in adults.
That will become obvious very quickly because the researchers will test volunteers’ antibodies.
The Vannonis and other Colorado participants will receive their second dose of the Novavax vaccine or placebo three weeks after their first dose and that’s when researchers will take more of their blood to measure their antibody levels. If antibodies develop, that will indicate that the Novavax vaccine is working.
The Vannonis and other participants who complete the trial will stay involved for two years. That’s because researchers are eager to learn how long antibodies to the coronavirus last both for adults or children.
Medical experts do know already that vaccines are working even better than natural immunities. That’s why they are encouraging everyone who is eligible to get vaccinated as soon as possible. To learn more about how to get a free vaccine, click here.
Other pediatric COVID-19 studies coming soon
Along with the Novavax pediatric COVID-19 vaccine study, researchers at Children’s Hospital Colorado soon will be conducting a clinical trial on the Pfizer COVID-19 vaccine for children ages 5 to 11.
Then, Levin soon will be helping with a Moderna clinical trial on children as young as six months to five years old. Johnson & Johnson vaccine trials for kids also may come to Colorado this summer.
“The way the government requests these trials be done is to move sequentially from older to younger. We first check to see if older children tolerate the vaccine well,” Levin said.
It is critical for younger children to determine that COVID vaccines will be as safe as in teens and adults.
Levin said researchers initially try lower doses with children, then determine the ideal dose. Interestingly, both the current Pfizer and Novavax COVID-19 vaccines for children use the same doses that adults receive.
Valentina Vannoni had no hesitation about having her children participate.
“This trial has been done in adults. The vaccine has been proven to be safe and effective,” she said.
“I’m really happy for children to get vaccines. In order for them to be able to enjoy a great summer, more of us need to get vaccinated. This is an amazing opportunity,” she said.
“It’s safe and the sooner more of us get vaccinated, the sooner we can go back to living our lives and hugging and kissing each other.”
Levin is optimistic about approvals for multiple vaccines for children by the end of the summer.
“I would think that children could begin to get immunized before the start of the school year,” He said “That is exciting for the children and for all of us.”
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