Atlanta (CNN) – With over 44 million people in the United States fully vaccinated against COVID-19, many adults are optimistic that a more normal life is on the horizon. Now families are wondering when the vaccine will be available for teenagers and children.
The official COVID-19 vaccine is currently only available to adults in the United States, except for the Pfizer / Bioentech vaccine, which is authorized for adults 16 and older.
While this prospect is likely to make the vaccine available to high school and middle school-aged children, young children may still be months away from vaccination when the next school year begins. The director of the National Institute of Allergy and Infectious Diseases, Dr. Anthony Fawcett says young children may have to wait until the first quarter of 2022.
However, tests are ongoing. Last week, the first children were vaccinated in a Moderna Phase 2/3 Kidkov pediatric trial, involving children aged 6 months to 11 years.
Dr. Budd, director of the Vanderbilt University Vaccine Research Program and an investigator of modern pediatric trials. Buddy Crich estimates that the COVID-19 vaccine will not be available for children 11 or older until new or early December.
Pfizer / Bioentech and Modern are testing their vaccines in people under 12, and experts are confident that the results will be ready to vaccinate 12 and more children for the next school year. The vaccine may be available for high-risk children 12 and older by July or August, Christ said.
Johnson and Johnson have announced plans to start testing its vaccine in people between the ages of 12 and 18, and J&J CEO Alex Gorsky said this month that the company will make one vaccine available to children under 18 by September. In February, Oxford University announced that it would begin testing the AstraZeneca vaccine in people between the ages of 1 and 1. Novavax said he expects his vaccine pediatrics to begin soon.
U.S. Each vaccine needs to be carefully tested in a pediatrician until sufficient data are generated to evaluate whether it is safe and effective for the Food and Drug Administration.
What does this mean for the coming school year?
Parents and teachers should be vaccinated by this fall, but many children, especially those under the age of 12, are unlikely to be vaccinated.
Children are more likely to become seriously ill or die from Covid-1 die than adults, and there is evidence that, despite precautions, the risk of transmitting the virus to school is lower.
“Children’s hospitals are not full because of this epidemic,” Kriech said. “The epidemic arose in a war-torn state – more than any other country – and yet our children’s hospitals are usually used for overflow from adult hospitals.”
U.S. Department of Disease Control and Prevention Most health professionals and officials, including centers, do not list vaccinations as a prerequisite for children to return to personal education, but they will add a degree of protection for students, school staff and their families. .
How will a pediatric trial work?
The goal of pediatric covid-19 vaccine tests will be to determine if the vaccine can protect children from getting sick if they are exposed to the virus. Researchers will test the vaccine first in adolescents and work from them to younger age groups, which may require different doses.
“We start with low doses and move on to doses until we know that Goldilocks is the moment where we give them just enough vaccines to achieve proper immunity, but without high doses of side effects.”
All participants in the initial part of the Modern Kidkov study will receive two 25, 50 or 100 microgram doses of the vaccine, so that researchers can determine the appropriate dose. The trial will then expand to include participants in the trial to study the safety and effectiveness of the vaccine.
Dr. R. Steve Plumpton, OB-GYN and investigator of the Kidkov study in Phoenix, Ste Rizzo, said the 14-month study would include planned pause, check-ups and blood draws.
Researchers hope to close the knowledge gained in adult tests.
“What we expect, and I think we’re close to, is capable of defining a number of antibodies in the bloodstream, which is the correlation of the defense we saw in those three large-phase experiments of 30 to 40,” a thousand people, “said Christ. Said.
Researchers will then explore that level of antibodies in pediatric participants to see if the vaccine provides protection.
“That way we don’t have to study 1,000,000 children, instead we can study 5,000 or 10,000 children,” Kriech said.
What are the concerns about side effects and safety?
“Kids aren’t just young adults,” Criche said. “They have an immune system that looks like an adult, but they have a different level of training, they’ve seen fewer viruses and they have fewer health problems.”
While it is not uncommon for a 40-year-old to experience fever and sore throat after vaccination, these side effects may be more difficult to tolerate for a 9-month-old.
“We really want to be thoughtful so that when we start a vaccination campaign in children, we can give pediatricians – but most importantly, parents – a full expectation of what they will see the day after one or two vaccinations.”
The director of the vaccine research center at Cincinnati Children’s Hospital and the investigator for the Pfizer trial at the hospital, Dr. Robert Frank reviews the “symptom diary” asked to keep participants.
“Children – if they have symptoms – have headaches, they feel tired. They may have muscle aches, but other than that, not really much,” Frank said. “Most symptoms go away in a day or two. There are a lot of people who have almost nothing.”
Some children who have experienced COVID-19 have MIS-C, or have contracted multisystem inflammatory syndrome in children, which is rare but can cause serious illness in some.
“We’ll be taking special care to make sure we’re not seeing it with the juice vaccine, or in conjunction with the vaccine, or in conjunction with that infection,” Creach said. “There’s no reason to think it’s going to be caused by the vaccine alone, but we’ll find out.”
Participants will also be monitored for rashes, fever, fatigue or other health issues.
The COVID-19 vaccine clinical trials are overseen by the Data and Safety Monitoring Board, which includes independent specialists who have access to trial data and may recommend a halt to the study if there are safety concerns.
Dr. Catherine Edwards is the Scientific Director of Vanderbilt University’s Vaccine Research Program and a member of the DSMB for the COVID-19 vaccine to be tested in children.
“If children get sick, they will be examined by investigators to see if the illness is related to the vaccine,” Edwards said. “Little attention will be paid to safety concerns.”
How can children participate in tests?
Plumpton said he has seen an enthusiastic response to the call for participants in Modern’s Kidkov study, which aims to register 7,550 participants in the US and Canada.
“It’s amazing how much parents come out and they are willing to try to help us make this clear to their children,” Plumpton said. “I told Modern that we can get all 6,750 patients here in Phoenix – and they have 75 sites in the United States and Canada.”
Plumpton noted that the trial did not have specific demographic requirements, but its response has been varied and trial sites have been spread across the country to accommodate a wide range of participants.
“For the most part we’re all getting along,” he said. “It’s happening because all parents want to protect their children.”
Rachel Guthrie, a latch and delivery nurse in Phoenix, Arizona, registered her 3-year-old son and 2-year-old daughter at the Moderna hearing. She said she wants to protect her children from any exposure and wishes her son had some protection in his personal preschool. They are set to receive their first shot this week.
“I jumped at the chance, because I want my kids to have that protection,” he said. “To get this vaccination approved for children, one has to be prepared to move on.”
Researchers hope that children will not be the only ones to benefit from the tests.
“We want this study to give other demographic groups the peace of mind that they can get vaccinated. ‘Hey, this 6-month-old got the vaccine – why am I 25, not ready to do it?'” Plumpton said.
The CNN-Wire ™ and 21 2021 Cable News Network, Inc., a time warrior company. All rights reserved to us.
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