Covid-19 vaccines currently approved in the United States are only available to adults, except for Pfizer / BioNTech’s vaccine, which is approved for people 16 years and older.
Although a vaccine will be available by the fall for high school and middle school children, younger children may still be months away from vaccination when the upcoming 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 term of 2022.
Trials are underway, however. Last week, the first children were vaccinated in Moderna’s phase 2/3 KidCOVE pediatric trial, which includes children from 6 months to 11 years.
Dr Buddy Creech, director of the Vanderbilt University’s Vaccine Research Program and a researcher in Moderna’s pediatric trials, estimates that the Covid-19 vaccine will only be available in early November or December for children 11 and younger.
Pfizer / BioNTech and Moderna have tested their vaccines on people as young as 12, and experts feel confident that the results will be ready in time to get children aged 12 and older vaccinated for the coming school year. Creech said vaccines are available by July or August for high-risk children 12 years and older.
Johnson & Johnson has announced plans to launch the vaccine in 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 the age of 20 by September. 18. In February, the University of Oxford announced that it would start vaccinating AstraZeneca in people aged 6 to 17 years.
But each vaccine must be carefully tested in pediatric populations until enough data is generated for the U.S. Food and Drug Administration to evaluate 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 the age of 12, are unlikely to do so.
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 viruses to school is low.
“Children’s hospitals were not yet full because of this pandemic,” Creech said. “The pandemic is raging in the United States – more than any other country – and yet our children’s hospitals are commonly used for flooding adult hospitals.”
Most health experts and authorities, including the U.S. Centers for Disease Control and Prevention, do not mention that children are vaccinated as a prerequisite for returning to personal learning, but they do provide some protection for students, school staff, and their families. .
How will pediatric trials work?
Pediatric Covid-19 vaccine trials are aimed at determining whether vaccines can protect children from disease if they are exposed to the virus. Researchers will first test the vaccines in teens and work them out to younger age groups, who need different doses.
“We start with low doses and increase the dose until we currently find the Goldilocks, where we give them just enough of the vaccine to get the right immune response, but without a high amount of side effects,” Creech said. .
All participants in the initial part of Moderna’s KidCOVE study received two doses of 25, 50 or 100 micrograms of the vaccine so that researchers could determine the appropriate dose. Then the trial will extend to participants receiving a placebo so that the safety and efficacy of the vaccine can be studied.
Dr. Steve Plimpton, an OB-GYN and researcher for the KidCOVE study in Phoenix, Arizona, said the 14-month study will include planned breaks, examinations and blood tests.
Researchers hope to build on the knowledge gained in adult trials.
“What we are hoping for, and I think what we are close to, is to be able to define a number of antibodies in the bloodstream that are a correlate of the protection we saw in that great phase three trials of 30 to 40 thousand. people, ‘says Creech.
Researchers will then look at the level of antibodies in pediatric participants to know that the vaccine provides protection.
“That way we do not have to do 30,000 children, but we can do five to ten thousand children instead,” Creech said.
What is concerned about side effects and safety?
“Children are not just small 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 fewer health problems.”
While it is not uncommon for a 40-year-old to experience a fever and a sore arm after being vaccinated, the side effects for a nine-month-old may be more difficult to tolerate.
“We really want to be considerate so that our children, but especially parents, can give a full expectation on what they can see after the vaccine during the day or two,” Creech said.
Dr. Robert Frenck, director of the Center for Vaccine Research at Cincinnati Children’s Hospital and investigator for the hospital’s Pfizer trial, assesses ‘symptom diaries’ that participants are asked to keep.
“The kids – if they have symptoms – have headaches, but they have fatigue. They can have muscle aches, but other than that, really not much,” Frenck said. “Most symptoms go away within a day or two. There are a number of people who have almost nothing.”
Some children who have contracted Covid-19 have experienced multiple-system MIS-C or inflammatory syndrome, which is rare but can cause some serious illnesses.
“We’re going to be watching it with particular interest to make sure we don’t see it in connection with the vaccine, or along with the vaccine plus an infection that could develop them along the way for months,” Creech said. “There’s no reason to think it’s just going to happen because of the vaccine, but we’re going to look for it.”
Participants will also be closely monitored for rash, fever, fatigue or other health problems.
Covid-19 clinical trials are overseen by a Data and Safety Monitoring Board (DSMB), made up of independent experts who have access to trial data and can recommend that studies be discontinued if there are safety issues.
Dr. Kathryn Edwards is a scientific director at Vanderbilt University’s vaccine research program and a member of the DSMB for a Covid-19 vaccine that will be tested in children.
“If children become ill, they will be seen by the investigators to see if there is a possibility that the disease is related to the vaccine,” Edwards said. “Careful attention will be paid to safety issues.”
How can children participate in trials?
Plimpton said he saw an enthusiastic response to the call for participants in Moderna’s KidCOVE study, which aims to enroll 6,750 participants in the U.S. and Canada.
“It’s amazing how many parents come out and are willing to help us get it right for their kids,” Plimpton said. “I told Moderna that we could probably get all 6,750 patients here in Phoenix – and that they have 75 establishments in the United States and Canada.”
Plimpton noted that the trial did not have specific demographic requirements, but that the response was diverse and that pilot sites were spread across the country to include a wide range of participants.
“We get mostly everyone,” he said. “It happens because all parents want to protect their children.”
Rachel Guthrie, a maternity and childbirth 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 exposure she encounters, and wants her son to have some protection at his personal kindergarten. They will receive their first shots this week.
“I emphasized the opportunity because I want my children to have that protection,” she said. “To approve the vaccination for children, someone must be willing to step forward.”
Researchers are hopeful that children will not be the only ones to benefit from the trials.
“We also want the study to give other demographic groups peace of mind that they can go get the vaccine. ‘Hey, this 6-month-old baby got the vaccine – why am I not willing to do that as a 25-year-old?’ ‘Plimpton said.