ATLANTA (CNN) – With more than 44 million people completely vaccinated against COVID-19 in the United States, many adults hope that a more normal life is on the horizon. Families are now wondering when vaccines will be available for teenagers and children.
COVID-19 vaccines currently licensed in the United States are only available for adults, with the exception of the Pfizer / BioNTech vaccine, which is licensed for people 16 years of age and older.
Although there is a chance that a vaccine will be available for high school and middle school children by this fall, younger children may still be a few months away from vaccination when the next school year begins. Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, said younger children may have to wait until the first quarter of 2022.
However, the trials are beginning. Last week, the first children were vaccinated in the KidCOVE Phase 2/3 Modern pediatric study, which includes children aged 6 months to 11 years.
Dr. Buddy Creech, director of the Vanderbilt University Vaccine Research Program and a researcher in pediatric studies at Moderna, estimates that a COVID-19 vaccine will not be available to children at least 11 years of age until November or December. before.
Pfizer / BioNTech and Moderna have tested their vaccines in people up to 12 years old, and experts are confident that the results will be ready in time to get 12-year-olds and over vaccinated for the next school year. Creech said the vaccines could be available to high-risk children up to 12 by July or August.
Johnson & Johnson announced plans to begin vaccine testing for 12- to 18-year-olds, and J&J CEO Alex Gorsky said this month that the company will likely have a vaccine available for children under 18 until September. In February, the University of Oxford announced that it would begin testing the AstraZeneca vaccine on people aged 6 to 17. Novavax said pediatric vaccine trials are expected to 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 assess whether it is safe and effective.
What does this mean for the next school year?
Parents and teachers should be vaccinated by this fall, but many children, especially those under the age of 12, probably 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 to school is low.
“Children’s hospitals were not full because of this pandemic,” Creech said. “The pandemic stole in the United States – more than in any other country – and yet our children’s hospitals were usually used for overflows from 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 a return to personal learning, but will add a degree of protection for students, school staff and their families. .
How will pediatric studies work?
Pediatric COVID-19 vaccine studies 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 go to younger age groups, who may need different doses.
“We start with low doses and go up in dose until we find that Goldilocks moment, when we only give them enough vaccine to get the right immune response, but without a lot of side effects,” Creech said.
All participants in the initial part of the KidCOVE study at Moderna will receive two doses of 25, 50 or 100 micrograms of vaccine, so that researchers can determine the appropriate dosage. The process 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, OB-GYN and investigator for the KidCOVE study in Phoenix, Arizona, said the 14-month study will include planned breaks, checks and blood draws.
Researchers hope to build on the knowledge gained in adult studies.
“What we hope and think we are getting closer to is being able to define a number of antibodies in the blood that are a correlate of the protection we saw in those big phase three studies of 30 to 40,000 people.” said Creech.
Researchers will then look for that level of antibodies in pediatric participants to know that the vaccine provides protection.
“This way we don’t have to study 30,000 children, instead we can study five or ten thousand children,” Creech said.
What are the concerns about side effects and safety?
“Kids aren’t just young adults,” Creech said. “They have immune systems that are very similar to adults, but have a different level of training, have seen fewer viruses and have fewer health problems.”
Although it is not uncommon for a 40-year-old man to have a fever and arm pain after vaccination, these side effects may be more difficult to tolerate for a 9-month-old child.
“We want to be really careful so that, as we launch vaccination campaigns for children, we can give pediatricians – but most importantly, parents – a full expectation of what they might see in a day or two. after the vaccine, ”Creech said.
Dr. Robert Frenck, director of the Vaccine Research Center at the Children’s Hospital of Cincinnati and an investigator for the Pfizer trial at the hospital, analyzes the “symptom journals” that participants are asked to keep.
“Children – if they have symptoms – have headaches, they’re tired. They may have muscle aches, but other than that, they’re not too much,” Frenck said. “Most symptoms go away in a day or two. There are a number of people who have almost nothing.”
Some children who have contracted COVID-19 have MIS-C or multisystemic inflammatory syndrome in children, which is rare but can cause severe illness in some.
“We will be following this with great interest to make sure we don’t see it in association with the vaccine, or in association with the vaccine plus an infection that could develop months down the road,” Creech said. “There is no reason to believe that this will only happen because of the vaccine, but we will look 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 data and safety monitoring committee, composed of independent experts who have access to the study data and may recommend discontinuation of studies if there are safety concerns.
Dr. Kathryn Edwards is the scientific director of Vanderbilt University’s Vaccine Research Program and a member of the DSMB for a COVID-19 vaccine that will be tested in children.
“If the children get sick, they will be seen by investigators to see if there is any possibility that the disease is related to the vaccine,” Edwards said. “There will be close attention to safety issues.”
How can children participate in rehearsals?
Plimpton said he saw an enthusiastic response to the call for participants in the KidCOVE study at Moderna, which aims to enroll 6,750 participants in the US and Canada.
“It’s amazing how much parents come out and are willing to try to help us get this for their children,” Plimpton said. “I told Moderna we could probably get all 6,750 patients here in Phoenix – and they have 75 sites in the United States and Canada.”
Plimpton noted that the process has no specific demographic requirements, but the response has been diverse and test sites are spread across the country to include a wide range of participants.
“For the most part, we get everyone,” he said. “It happens because all parents want to protect their children.”
Rachel Guthrie, a nurse from 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 son to have some degree of protection from his preschooler in person. They will receive the first photos this week.
“I jumped at the chance, because I want my kids to have that protection,” she said. “In order to get approval for this vaccination for children, someone has to be willing to take a step forward.”
Researchers hope that children will not be the only ones to benefit from their studies.
“We also want the study to give the other demographic groups peace of mind that they can get the vaccine. Hey, this 6-month-old got the vaccine – why am I, 25, not wanting to do it? Said Plimpton.
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