ATLANTA (CNN) – With more than 44 million people completely vaccinated against COVID-19 in the United States, many adults expect a more normal life on the horizon. Now families are wondering when vaccines will be available for teens and children.
COVID-19 vaccines currently authorized in the United States are only available for adults, except for the Pfizer / BioNTech vaccine, which is authorized for people over 16 years of age.
While there is a possibility that a vaccine will be available for high school and middle-aged children this fall, younger children may still be months away from vaccination 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 quarter of 2022.
Still, testing is beginning. Last week, the first children were vaccinated in Moderna’s Phase 2/3 Pediatric KidCOVE trial, which includes children ages 6 months to 11 years.
Dr. Buddy Creech, director of the Vanderbilt University Vaccine Research Program and researcher in pediatric trials at Moderna, estimates that a COVID-19 vaccine will not be available for children 11 years of age or younger until November or December, as see you soon.
Pfizer / BioNTech and Moderna have been testing their vaccines on people up to 12 years old and experts are confident that the results will be ready to vaccinate children 12 years or older for the next school year. Creech said the vaccines could be available for high-risk children 12 and older in July or August.
Johnson & Johnson has announced plans to begin testing its vaccine on 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 in September. In February, Oxford University announced that it would begin testing the AstraZeneca vaccine in people aged 6 to 17. Novavax said it expects pediatric trials of its vaccine to begin soon.
But each vaccine must be carefully tested in pediatric populations until enough data is generated for the U.S. 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 this fall, but many children, especially those under 12, are unlikely to 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 virus transmission in school is low.
“Children’s hospitals have not been filled because of this pandemic,” Creech said. “The pandemic caused a furor in 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 U.S. Centers for Disease Control and Prevention, do not indicate vaccination of children as a prerequisite for returning to face-to-face learning, but it will add a degree of protection for children. students, school staff and their families. .
How will pediatric trials work?
Pediatric COVID-19 vaccine trials will aim to determine whether vaccines can protect children from getting sick if exposed to the virus. Researchers will first try vaccines in adolescents and work with younger age groups, who may need different doses.
“We start with low doses and move on to 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 initial part of Moderna’s KidCOVE study will receive two doses of 25, 50, or 100 micrograms of vaccine, so researchers can determine the appropriate dosage. The trial will then be expanded to include participants who were given a placebo, so that the safety and efficacy of the vaccine can be studied.
Dr. Steve Plimpton, a gynecologist and researcher at the KidCOVE study in Phoenix, Arizona, said the 14-month study will include scheduled breaks, checkups, and blood draws.
Researchers hope to leverage the knowledge gained in adult trials.
“What we expect, and I think we’re close to, is to be able to define a series of antibodies in the bloodstream that are a correlate of the protection we saw in those big phase three trials of 30 to 40,000 people.” , said Creech.
Researchers will then look for this level of antibodies in pediatric participants to find out if the vaccine provides protection.
“That way we don’t have to do studies of 30,000 kids, we can do studies of five or ten thousand kids,” Creech said.
What are the concerns about side effects and safety?
“Kids aren’t just little adults,” Creech said. “They have immune systems that look a lot like adults, but they have a different level of training, they’ve seen fewer viruses and they have fewer health problems.”
While it’s not uncommon for a 40-year-old to experience fever and arm pain after getting vaccinated, these side effects may be harder to tolerate for a 9-month-old boy.
“We want to be really thoughtful so that as we start vaccination campaigns in children, we can give pediatricians (but especially 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 Pfizer trial investigator at the hospital, reviews the “symptom diaries” that participants are asked to keep.
“Kids (if they have symptoms) have a headache, they have fatigue. They may have some muscle pain, but other than that, really not much,” Frenck said. “Most of the symptoms go away in a day or two. There are a number of people who have almost nothing.”
Some children who contracted COVID-19 experienced MIS-C or multisystem inflammatory syndrome in children, which is uncommon, but in some can cause serious illness.
“We will look at it with particular interest to make sure we don’t see it in association with the vaccine or in association with the vaccine plus an infection that can develop for months,” Creech said. “There’s no reason to think this will happen just because of the vaccine, but we’ll be looking for it.”
Participants will also be closely monitored for rashes, fever, fatigue or other health problems.
Clinical trials on COVID-19 vaccines are overseen by a data and safety control committee, consisting of independent experts who have access to the trial data and who may recommend that studies be stopped if there are safety issues.
Dr. Kathryn Edwards is the scientific director of the Vanderbilt University Vaccine Research Program 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’s any chance the disease is vaccine-related,” Edwards said. “There will be thorough attention to security issues.”
How can children participate in tests?
Plimpton said he has seen an enthusiastic response to the call for participants in Moderna’s KidCOVE study, which aims to enroll 6,750 participants in the United States and Canada.
“It’s amazing how much parents are coming out and are willing to try to help us achieve this for their children,” Plimpton said. “I told Moderna that we could probably get the 6,750 patients here in Phoenix, and that they have 75 locations in the United States and Canada.”
Plimpton noted that the trial 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’s happening because all parents want to protect their children.”
Rachel Guthrie, a part-time nurse in Phoenix, Arizona, enrolled her 3-year-old son and 2-year-old daughter in the Modern Trial. He said he wants to protect his children from any exposure he finds and wants his child to have some degree of protection in his face-to-face preschool. They are ready to receive their first shots this week.
“I jumped at the chance, because I want my kids to have that protection,” he said. “To get approval for this vaccine for children, someone has to be willing to move forward.”
Researchers hope the children will not be the only ones to benefit from the trials.
“We also want the study to give other demographic groups the peace of mind they can go to get the vaccine.” Hey, this 6-month-old baby got the vaccine – why am I, 25, not willing to do it? said Plimpton.
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