ATLANTA (CNN) – With more than 44 million people fully vaccinated against COVID-19 in the United States, many adults are hoping that a more normal life is on the horizon. Now families are wondering when vaccines will be available for teens and children.
COVID-19 vaccines currently approved in the United States are only available for adults, with the exception of the Pfizer / BioNTech vaccine, which is approved for people 16 years of age and older.
While there’s a chance that a vaccine will be available for high school and high school kids by this fall, younger kids could 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.
However, trials are underway. Last week, the first children were vaccinated in Moderna’s Phase 2/3 KidCOVE pediatric study, which includes children 6 months to 11 years of age.
Dr. Buddy Creech, director of Vanderbilt University’s vaccine research program and a researcher in Moderna’s pediatric studies, estimates that a COVID-19 vaccine won’t be available for children 11 and under until November or December.
Pfizer / BioNTech and Moderna have tested their vaccines in people as young as 12 years old, and experts are confident that the results will be ready in time to vaccinate children 12 and older for the upcoming school year. Creech said vaccines could be available in July or August for high-risk children 12 and older.
Johnson & Johnson has announced plans to start 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 18 by September. In February, the University of Oxford announced that AstraZeneca’s vaccine would be tested in people aged 6 to 17 years. Novavax said it expects pediatric trials of the vaccine to start soon.
But any vaccine must be carefully tested in pediatric populations until sufficient 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 coming school year?
Parents and teachers should be vaccinated by this fall, but many children, especially children under 12, are unlikely to be vaccinated.
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 at school is low.
“Children’s hospitals have not been full because of this pandemic,” said Creech. “The pandemic was raging in the United States – more than any other country – and yet our children’s hospitals were mostly used to flood adult hospitals.”
Most health experts and authorities, including the U.S. Centers for Disease Control and Prevention, do not list childhood vaccination as a prerequisite for a return to personal learning, but it will provide some level of protection for students, school personnel, and their families.
How do pediatric studies work?
Pediatric COVID-19 vaccine studies will aim to determine whether vaccines can protect children from getting sick when exposed to the virus. Researchers will test the vaccines in teens first and work their way into younger age groups, who may require different dosages.
“We start with low doses and continue in dosing until we find that Goldilocks moment where we give them just enough of the vaccine to get the right immune response, but without many side effects,” Creech said.
All participants in the first part of Moderna’s KidCOVE study will receive two doses of 25, 50 or 100 micrograms of the vaccine so that researchers can determine the correct dosage. The trial will then be expanded to include participants who receive a placebo so that the safety and efficacy of the vaccine can be studied.
Dr. Steve Plimpton, an obstetrician and researcher for the KidCOVE study in Phoenix, Arizona, said the 14-month study will include scheduled breaks, checkups, and blood draws.
Researchers hope to build on the knowledge gained in the trials on adults.
“What we’re hoping for, and I think we’re close, is that we’ll be able to define a number of antibodies in the bloodstream that correlate with the protection we saw in those big Phase Three studies of 30 to 40 a thousand people, ”said Creech.
Researchers will then look for that level of antibodies in pediatric participants to know that the vaccine offers protection.
“That way, we don’t have to do studies on 30,000 children, but instead we can do studies on five or ten thousand children,” said Creech.
What are side effects and safety concerns?
“Kids aren’t just little adults,” said Creech. “They have an immune system that is very similar to adults, but they have a different level of education, they have seen fewer viruses and they have fewer health problems.”
While it’s not uncommon for a 40-year-old to experience a fever and a sore arm after being vaccinated, those side effects can be more difficult for a 9-month-old to tolerate.
“We want to be really considerate so that when we launch vaccination campaigns in children, we can give pediatricians – but especially parents – a full expectation of what they might see the day or two after vaccination,” Creech said.
Dr. Robert Frenck, director of the Vaccine Research Center at Cincinnati Children’s Hospital and investigator for the Pfizer study at the hospital, discusses “symptom diaries” that participants are asked to keep.
“The kids – if they have symptoms – have a headache or fatigue. They may have some muscle pain, but otherwise not much,” Frenck said. “Most symptoms go away within a day or two. There are some people who have almost nothing.”
Some children who contracted COVID-19 developed MIS-C or multisystem inflammatory syndrome in children, which is rare but can cause serious illness in some.
“We’ll be watching that with particular interest to make sure we don’t see it in connection with the vaccine, or in connection with the vaccine plus an infection that they can develop months later,” Creech said. “There is no reason to believe that this will happen through the vaccine alone, but we will look for it.”
Participants will also be closely monitored for a rash, fever, fatigue, or other health problems.
Clinical studies with COVID-19 vaccines are monitored by a Data and Safety Monitoring Board, made up of independent experts who have access to study data and who can recommend that studies be stopped if there are safety concerns.
Dr. Kathryn Edwards is Scientific Director of Vanderbilt University’s Vaccine Research Program and a member of the DSMB for a COVID-19 vaccine to be tested in children.
“When children get sick, the researchers will see them to see if the disease is related to the vaccine,” Edwards said. “There will be close attention to security concerns.”
How can children participate in trials?
Plimpton said he responded enthusiastically to the call to participants in Moderna’s KidCOVE study, which aims to enroll 6,750 participants in the US and Canada.
“It’s amazing how much the parents are coming out and willing to try and help us make this free for their children,” said Plimpton. “I told Moderna we could probably get all 6,750 patients here in Phoenix – and they have 75 locations in the United States and Canada.”
Plimpton noted that the trial has no specific demographic requirements, but the response was diverse and trial sites are located across the country and include a wide variety of participants.
“For the most part, we get everyone,” he said. “It happens because all parents want to protect their children.”
Rachel Guthrie, an occupational and delivery nurse in Phoenix, Arizona, enrolled her 3-year-old son and 2-year-old daughter for the Moderna trial. She said she wants to protect her children from any exposure she comes across and wants her son to have some measure of protection in his personal kindergarten. They will receive their first recordings this week.
“I took the opportunity because I want my children to have that protection,” she said. “To get the approval of this childhood vaccination, someone has to be willing to step forward.”
Researchers hope that not only children will benefit from the trials.
“We also want the study to give other demographics peace of mind that they can get the vaccine.” “Hey, this 6-month-old baby got the vaccine – why as a 25-year-old don’t I want to do it?” Said Plimpton .
The-CNN-Wire ™ & © 2021 Cable News Network, Inc., a Time Warner Company. All rights reserved.