ATLANTA (CNN) – With more than 44 million people fully vaccinated against COVID-19 in the United States, many adults are hopeful that a more normal life is on the horizon. Now families are wondering when vaccines will be available for teens and children.
The COVID-19 vaccines currently licensed in the United States are only available for adults, except for the Pfizer / BioNTech vaccine, which is licensed for individuals 16 years of age and older.
While there is a chance that a vaccine will be available to high school and high school age children this fall, younger children may still be months away from receiving the vaccine when the next school year begins. Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, has said that younger children may have to wait until the first trimester of 2022.
However, trials are underway. Last week, the first children were vaccinated in Moderna’s KidCOVE Phase 2/3 pediatric trial, which includes children ages 6 months to 11 years.
Dr. Buddy Creech, director of the Vaccine Research Program at Vanderbilt University and an investigator in Moderna’s pediatric trials, estimates that a COVID-19 vaccine will not be available to children 11 and under until November or December, as soon.
Pfizer / BioNTech and Moderna have been testing their vaccines in people as young as 12, and experts are confident that the results will be ready in time for children 12 and older to get vaccinated for the next school year. Creech said the vaccines could be available to high-risk children 12 and older in July or August.
Johnson & Johnson has announced plans to begin testing its vaccine in people ages 12 to 18, and J&J CEO Alex Gorsky said this month that the company will likely have a vaccine available for children under the age of 18 in September. In February, the University of Oxford announced that it would begin testing the AstraZeneca vaccine in people ages 6 to 17. Novavax said it hopes pediatric trials of its vaccine will begin soon.
But each vaccine must be carefully tested in pediatric populations until enough data is generated for the US Food and Drug Administration to evaluate whether it is safe and effective.
What does this mean for the next school year?
Parents and teachers should get vaccinated by this fall, but many children, especially those under the age of 12, likely will not be.
Children are much less likely to become seriously ill or die from COVID-19 than adults, and there is growing evidence that, with proper precautions, the risk of transmitting the virus at school is low.
“Children’s hospitals have not been full due to this pandemic,” Creech said. “The pandemic swept through the United States, more than in any other country, and yet our children’s hospitals were typically used to overflow adult hospitals.”
Most health experts and authorities, including the US Centers for Disease Control and Prevention, do not list vaccinating children as a prerequisite for returning to in-person learning, but will add a degree of protection for students, school personnel and their families.
How will pediatric trials work?
Trials of the pediatric COVID-19 vaccine will aim to determine whether vaccines can protect children from getting sick if they are exposed to the virus. Researchers will test the vaccines in adolescents first and advance to the younger age groups, who may need different doses.
“We started with low doses and progressed through the dose until we find the Goldilocks moment, where we give them enough vaccine to get the right immune response, but without a lot of side effects,” Creech said.
All participants in the early part of Moderna’s KidCOVE study will receive two doses of the 25-, 50-, or 100-microgram vaccine so that researchers can determine the appropriate dose. The trial will then be expanded to include participants receiving a placebo so that the safety and efficacy of the vaccine can be studied.
Dr. Steve Plimpton, an OB-GYN and KidCOVE Study Investigator in Phoenix, Arizona, said the 14-month study will include planned breaks, check-ups and blood draws.
The researchers hope to build on the knowledge gained from adult trials.
“What we hope for, and I think we are close, is to be able to define a series of antibodies in the bloodstream that are a correlate of the protection we saw in those large phase three trials of 30 to 40 thousand people,” Creech said.
The researchers will then look for that level of antibodies in pediatric participants to learn that the vaccine provides protection.
“That way we don’t have to do studies of 30,000 children, we can do studies of five or ten thousand children instead,” Creech said.
What are the side effect and safety concerns?
“Children are not just little adults,” Creech said. “They have an immune system that looks a lot like adults, but they have a different level of training, they have seen fewer viruses and they have fewer health problems.”
While it’s not unusual for a 40-year-old to experience a fever and arm pain after getting vaccinated, those side effects can be more difficult for a 9-month-old to tolerate.
“We want to be really thoughtful so that, as we launch vaccination campaigns in children, we can give pediatricians, but more importantly, parents, a full expectation of what they might see during the day or two after the vaccine, “Creech said.
Dr. Robert Frenck, director of the Cincinnati Children’s Hospital Vaccine Research Center and investigator of the Pfizer trial at the hospital, reviews the “symptom diaries” that participants are asked to keep.
“Kids, if they have symptoms, they have headaches, they are having fatigue. They may have some muscle pain, but other than that, not really much,” Frenck said. “Most of the symptoms go away in a day or two. There are many people who have almost nothing.”
Some children who contracted COVID-19 experienced MIS-C, or multi-system inflammatory syndrome in children, which is rare but can cause serious illness in some.
“We’re going to be watching that with particular interest to make sure we’re not looking at it in association with the vaccine, or in association with the vaccine plus an infection that could develop months later,” Creech said. “There is no reason to think that this is going to happen just because of the vaccine, but we are going to be looking for it.”
Participants will also be closely monitored for rashes, fever, fatigue, or other health problems.
COVID-19 vaccine clinical trials are overseen by a Safety and Data Monitoring Board, made up of independent experts who have access to trial data and may recommend that studies be stopped if there are safety concerns.
Dr. Kathryn Edwards is the scientific director of the Vaccine Research Program at Vanderbilt University and a member of the DSMB for a COVID-19 vaccine to be tested in children.
“If children get sick, researchers will see them to see if there is any possibility that the disease is related to the vaccine,” Edwards said. “There will be meticulous attention to security issues.”
How can children participate in trials?
Plimpton said he has seen an enthusiastic response to the call for participants for Moderna’s KidCOVE study, which aims to enroll 6,750 participants in the US and Canada.
“It’s amazing how much parents are coming out and willing to try to help us clarify this for their children,” Plimpton said. “I told Moderna that we could probably have the 6,750 patients here in Phoenix, and they have 75 sites in the United States and Canada.
Plimpton noted that the trial does not have specific demographic requirements, but the response has been diverse and the trial sites are spread across the country to include a wide range of participants.
“For the most part, we are welcoming everyone,” he said. “It is happening because all parents want to protect their children.”
Rachel Guthrie, a labor and delivery nurse in Phoenix, Arizona, enrolled her 3-year-old son and 2-year-old daughter in the Moderna trial. She said she wants to protect her children from any exposure she encounters and wants her child to have some degree of protection at his preschool in person. They are ready to receive their first injections this week.
“I took the opportunity, because I want my children to have that protection,” he said. “To get this vaccine for children approved, someone has to be willing to step up.”
The researchers hope that children are not the only ones to benefit from the tests.
“We also want the study to give other demographic groups the peace of mind that they can go get vaccinated. ‘Hey, this 6-month-old baby got the vaccine. Why am I, when I’m 25 years old, not up to it? ‘”Plimpton said.
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