When will kids and teens be vaccinated against COVID-19
With quite 44 million people fully vaccinated against COVID-19 within us, many adults are hopeful that more normal life is on the horizon. Now families are wondering when vaccines are going to be available for teens and youngsters.
COVID-19 vaccines currently authorized within us are only available for adults, except Pfizer/BioNTech vaccine, which is permitted for people ages 16 and older.
While there’s an opportunity that a vaccine is going to be available to high school and middle school-age children by this fall, younger children should be months faraway from vaccination when the upcoming academic year begins. Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, has said younger children may need to wait until the primary quarter of 2022.
Trials are becoming underway, though. Last week, the primary children were vaccinated in Moderna’s Phase 2/3 KidCOVE pediatric trial, which incorporates children ages 6 months to 11 years.
Dr. Buddy Creech, director of Vanderbilt University’s Vaccine Research Program and an investigator in Moderna’s pediatric trials, estimates a COVID-19 vaccine won’t be available to children 11 and younger until November or December, at the earliest.
Pfizer/BioNTech and Moderna are testing their vaccines in people as young as 12, and experts are feeling confident that the results are going to be ready in time to urge kids 12 and up vaccinated for the upcoming academic year. Creech said vaccines might be available for high-risk kids 12 and older by July or August.
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 corporate will likely have a vaccine available for youngsters under the age of 18 by September. In February, the University of Oxford announced it might begin testing AstraZeneca’s vaccine in people ages 6 to 17. Novavax said it expects pediatric trials of its vaccine to begin shortly.
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But each vaccine must be carefully tested in pediatric populations until enough data is generated for the US Food and Drug Administration to gauge whether it's safe and effective.
What does this mean for the upcoming school year?
Parents and teachers should be vaccinated by this fall, but many kids, especially those under the age of 12, will likely not be.
Children are much less likely to urge seriously ill or die from COVID-19 than adults, and there's increasing evidence that with the proper precautions, the danger of in-school virus transmission is low.
“Children’s hospitals haven't been full due to this pandemic,” said Creech. “The pandemic raged within us — quite the other country — and yet our children’s hospitals were typically getting used for the overflow from adult hospitals.”
Most health experts and authorities, including the US Centers for Disease Control and Prevention, don’t list vaccinating children as a prerequisite for a return to in-person learning, but it'll add a degree of protection for college kids, school staff, and their families.
How will pediatric trials work?
Pediatric COVID-19 vaccine trials will aim to work out whether vaccines can protect kids from becoming sick if they're exposed to the virus. Researchers will test the vaccines in teens first and work their way right down to younger age groups, which can need different dosages.
“We start with low doses and move up within the dosage until we discover that Goldilocks moment, where we give them only enough of the vaccine to urge the proper immune reaction but without a high amount of side effects,” Creech said.
All participants within the initial part of Moderna’s KidCOVE study will receive two 25, 50, or 100 microgram doses of the vaccine, so researchers can determine the acceptable dosing. Then the trial will expand to incorporate participants who are given a placebo, therefore the safety and efficacy of the vaccine are often studied.
Dr. Steve Plimpton, an OB-GYN and investigator for the KidCOVE study in Phoenix, Arizona, said the 14-month study will include planned pauses, check-ups, and blood draw.
Researchers hope to create off the knowledge gained within the adult trials.
“What we’re hoping for, and that I think what we’re on the brink of, is having the ability to define several antibodies within the bloodstream that are a correlate of the protection that we saw in those big Phase Three trials of 30 to 40 thousand people,” said Creech.
Researchers will then search for that level of antibodies in pediatric participants to understand that the vaccine is providing protection.
“That way we don’t need to do studies of 30,000 children, we will do studies of 5 or ten thousand children instead,” Creech said.
What are concerns about side effects and safety?
“Children aren't just little adults,” Creech said. “They have immune systems that look an entire lot like adults, but they need a special level of coaching, they’ve seen fewer viruses and that they have fewer health problems.”
While it’s commonplace for a 40-year-old to experience fever and sore arm after getting vaccinated, those side effects could also be harder for a 9-month-old to tolerate.
“We want to be really thoughtful so that as we launch vaccine campaigns in children, we will give pediatricians — but most significantly, parents — a full expectation of what they could see over the day or two following vaccine,” Creech said.
Dr. Robert Frenck, director of the Vaccine research facility at Cincinnati Children’s Hospital and investigator for the Pfizer trial at the hospital, reviews “symptom diaries” that participants are asked to stay.
“The kids — if they’re having symptoms — are having headaches, they’re having fatigue. they'll have some muscle ache, but aside from that, really not much,” said French. “Most symptoms are departure during a day or two. Several people have almost nothing.”
Some children who contracted COVID-19 experienced MIS-C, or multisystem inflammatory syndrome in children, which is rare but can cause severe illness in some.
“We’re getting to be watching that with particular interest to form sure that we aren’t seeing it in association with the vaccine, or in association with the vaccine plus an infection that they could develop months down the road,” said Creech. “There’s no reason to think that that’s getting to happen thanks to the vaccine alone, but we’re getting to be trying to find it.”
Participants also will be monitored closely for rashes, fever, fatigue, or other health issues.
COVID-19 vaccine clinical trials are overseen by a knowledge and Safety Monitoring Board (DSMB), comprised of independent experts who have access to trial data and may recommend studies be halted if there are safety concerns.
Dr. Kathryn Edwards may be a scientific director at Vanderbilt University’s Vaccine Research Program and a member of the DSMB for a COVID-19 vaccine which will be tested in children.
“If children get sick, they’ll be seen by the investigators to ascertain whether there was any possibility that the illness is said to the vaccine,” said Edwards. “There are going to be meticulous attention to safety concerns.”
How can children participate in trials?
Plimpton said he has seen an enthusiastic response to the decision for participants for Moderna’s KidCOVE study, which aims to enroll 6,750 participants within the US and Canada.
“It’s amazing what proportion the oldsters are beginning and are willing to undertake to assist us to get this cleared for his or her kids,” said Plimpton. “I told Moderna that we could probably get all 6,750 patients here in Phoenix — and that they have 75 sites within us and Canada.”
Plimpton noted that the trial doesn't have specific demographic requirements, but the response has been diverse and trial sites are opened up across the state to incorporate a broad range of participants.
“For the foremost part, we’re getting everybody,” he said. “It’s happening because all parents want to guard their kids.”
Rachel Guthrie, a labor and delivery nurse in Phoenix, Arizona, enrolled her 3-year-old son and 2-year-old daughter in the Moderna trial. She said she wants to guard her children against any exposure she encounters and needs her son to possess a point of protection at his in-person preschool. They’re set to receive their first shots in the week.
“I jumped at the chance because I would like my children to possess that protection,” she said. “To get the approval of this vaccination for teenagers, someone has got to be willing to breakthrough .”
Researchers are hopeful that youngsters won’t be the sole ones who enjoy the trials.
“We also want the study to offer other demographic groups peace of mind that they will go get the vaccine. ‘Hey, this 6-month-old baby got the vaccine — why am I, as a 25-year-old, not willing to try to do it?’” said Plimpton.
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