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 teenagers and children.
COVID-19 vaccines currently authorized in the United States are available only to adults, except the Pfizer / BioNTech vaccine, which is authorized for people aged 16 and over.
Although there is a chance that a vaccine will be available for high school and high school 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, said that younger children may have to wait until the first quarter of 2022.
Tests are in progress, however. Last week, the first children were vaccinated in the Phase 2/3 KidCOVE pediatric study from Moderna, which includes children aged 6 months to 11 years.
Dr. Buddy Creech, director of the Vaccine Research Program at Vanderbilt University and a researcher on the pediatric tests at Moderna, estimates that the COVID-19 vaccine will not be available for children 11 years or younger until at least November or December.
Pfizer / BioNTech and Moderna have been testing their vaccines on 12-year-olds, and experts are confident that the results will be ready in time to vaccinate children 12 and older for the next school year. Creech said vaccines may be available for high-risk children 12 and older in July or August.
Johnson & Johnson announced plans to start testing its vaccine on people aged 12 to 18, and J&J CEO Alex Gorsky said this month that the company is likely to have a vaccine available for children under 18 in September. In February, the University of Oxford announced that it would start testing the AstraZeneca vaccine in people aged 6 to 17 years. Novavax said it expects pediatric testing of its vaccine to begin soon.
But each vaccine needs to 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 by autumn, but many children, especially those under the age of 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 the right precautions, the risk of transmitting the virus at school is low.
“Children’s hospitals are not overcrowded because of this pandemic,” said Creech. “The pandemic has spread in the United States – more than in any other country – and yet our children’s hospitals were being used to overflow adult hospitals.”
Most health experts and authorities, including the Centers for Disease Control and Prevention in the United States, do not list vaccinating children as a prerequisite for returning to personal learning, but will add a degree of protection for students, staff and staff. school and their families.
How will pediatric tests work?
Pediatric COVID-19 vaccine trials will aim to determine whether vaccines can protect children from falling ill if they are exposed to the virus. Researchers will test vaccines on teenagers first and will work in younger age groups, who may need different dosages.
“We started with low doses and increased the dosage until we found that Goldilocks moment, where we give them just enough of the vaccine to get the right immune response, but without a lot of side effects,” said Creech.
All participants in the initial 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 appropriate dosage. Then, the trial will 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 OB-GYN and investigator for the KidCOVE study in Phoenix, Arizona, said the 14-month study will include planned breaks, check-ups and blood collection.
The researchers hope to develop the knowledge gained from tests with adults.
“What we expect, and I think we are close, is to be able to define a series of antibodies in the bloodstream that are a correlation of protection that we saw in those big Phase Three tests of 30 to 40 thousand people,” said Creech.
The researchers will then look for this level of antibodies in pediatric participants to see if the vaccine is providing protection.
“That way, we don’t have to do studies for 30,000 children, we can do studies for five or ten thousand children instead,” said Creech.
What are the concerns about side effects and safety?
“Children are not just small adults,” said Creech. “They have an immune system very similar to that of adults, but they have a different level of training, have seen less viruses and have less health problems.”
Although it is not uncommon for a 40-year-old to have a fever and pain in the arm after being vaccinated, these side effects can be more difficult to tolerate for a 9-month-old child.
“We want to be really careful that, when launching vaccine campaigns in children, we can give pediatricians – but, most importantly, parents – a complete expectation of what they may see over the course of a day or two after the vaccine,” said Creech.
Dr. Robert Frenck, director of the Vaccine Research Center at Cincinnati Children’s Hospital and investigator for the Pfizer study at the hospital, analyzes the “symptom diaries” that participants should keep.
“Children – if they are having symptoms – are having headaches, are having fatigue. They may have some muscle pain, but other than that, really not much,” said Frenck. “Most symptoms go away in a day or two. Many people 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 serious illness in some.
“We will be watching this with particular interest to make sure that we are not seeing it in association with the vaccine, or in association with the vaccine plus an infection that they can develop months later,” said Creech. “There is no reason to think that this will happen because of the vaccine alone, but we will be looking for it.”
Participants will also be monitored closely for rashes, fever, fatigue or other health problems.
The clinical trials of the COVID-19 vaccine are overseen by a Data and Safety Monitoring Board, composed of independent experts who have access to trial data and can recommend that studies be suspended 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 that will be tested in children.
“If the children get sick, they will be seen by the researchers to see if there is any possibility that the disease is related to the vaccine,” said Edwards. “There will be meticulous attention to security issues.”
How can children participate in trials?
Plimpton said he saw an enthusiastic response to the call for participants for Moderna’s KidCOVE study, which aims to enroll 6,750 participants in the United States and Canada.
“It’s amazing how much parents are taking on and willing to try to help us clarify this for their children,” said Plimpton. “I told Moderna that we would probably get all 6,750 patients here in Phoenix – and they have 75 units in the United States and Canada.”
Plimpton noted that the trial has no specific demographic requirements, but the response was diverse and the trial sites are spread across the country to include a wide range of participants.
“For the most part, we’re taking everyone,” he said. “It is happening because all parents want to protect their children.”
Rachel Guthrie, a labor nurse in Phoenix, Arizona, enrolled her 3-year-old son and 2-year-old daughter in the Moderna study. She said she wants to protect her children from any exposure she encounters and that her child has some degree of protection in the preschool classroom. They are ready to receive their first doses this week.
“I seized the opportunity, because I want my children to have that protection,” she said. “To get approval for this vaccination for children, someone has to be willing to step forward.”
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 peace of mind that they can get the vaccine. ‘Hey, this 6 month old baby got vaccinated – why am I, as a 25 year old, not willing to do that? ‘”Said Plimpton.
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