The Covid-19 vaccine currently licensed in the United States is only available to adults, with the exception of the Pfizer / BioNTech vaccine, which is licensed for people over the age of 16.
High school and junior high school children may have access to the vaccine by this fall, but as the next school year begins, younger children may still be months away from vaccination. There is. Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, said young children may have to wait until the first quarter of 2022.
However, testing is ongoing. Last week, the first children were vaccinated in Moderna’s Phase 2/3 KidCOVE pediatric trial, which included children aged 6 months to 11 years.
Dr. Buddy Creech, director of the Vanderbilt University Vaccine Research Program and researcher in Moderna’s pediatric trials, estimates that the Covid-19 vaccine will not be available until November or December at the earliest.
Pfizer / BioNTech and Moderna are testing vaccines in young people aged 12 and experts are confident that they are ready to vaccinate children over the age of 12 in the next school year. .. By July or August, the vaccine could be available to high-risk children over the age of 12, according to Kulich.
Johnson & Johnson has announced plans to begin testing vaccines in people aged 12-18. Alex Gorsky, CEO of J & J, said this month that the vaccine will be available to children under the age of 18 by September. In February, Oxford University announced that it would begin testing the AstraZeneca vaccine in people aged 6 to 17 years. Novabax said he expects pediatric trials of the vaccine to begin shortly.
However, each vaccine should be carefully tested in a pediatric population until sufficient data are generated to assess whether the US Food and Drug Administration is safe and effective.
What does this mean for the next academic year?
Parents and teachers must be vaccinated by this fall, but many children, especially children under the age of 12, may not be vaccinated.
Children are much less likely to become seriously ill or die of Covid-19 than adults, and there is increasing evidence that, with proper precautions, the risk of viral transmission at school is low.
“The children’s hospital wasn’t full because of this pandemic,” Kleech said. “In the United States, pandemics are intensifying and more than in any other country, yet our children’s hospitals were typically used for overflows from adult hospitals.”
Most health professionals and authorities, including the US Centers for Disease Control and Prevention, do not list children who are vaccinated as a prerequisite for returning to face-to-face learning, but to some extent to students, school staff and their families. Add protection for.
How Do Pediatric Exams Work?
The Pediatric Covid-19 Vaccine Trial aims to determine if a vaccine can protect a child from illness if the child is exposed to the virus. Researchers first test the vaccine in their teens and move towards a younger age group who may need different doses.
“We start with a low dose and increase it until we find the moment of Goldilocks, where we give enough vaccine to get a proper immune response, but without the large side effects. “Kreech said.
All participants in the first part of Moderna’s KidCOVE study will be vaccinated twice with 25, 50, or 100 micrograms of the vaccine, allowing researchers to determine the appropriate dose. The study will then be expanded to include participants who received placebo, allowing the study of vaccine safety and efficacy.
Dr. Steve Primpton, a researcher at OB-GYN’s KidCOVE study in Phoenix, Arizona, said the 14-month study included planned suspensions, tests, and blood draws.
Researchers want to build on the knowledge gained from adult exams.
“What we want, and what we are approaching, is the number of antibodies in the bloodstream, which is a correlation of protection seen in those large phase 3 trials of 30-40. It can be defined. Thousands, “said Kleech.
Researchers then look for that level of antibody in pediatric participants to find out that the vaccine provides protection.
“Then you don’t have to study 30,000 children, you can study 50,000 to 10,000 children instead,” Kulich said.
What are your side effects and safety concerns?
“Children aren’t just small adults,” Kulich said. “They have an immune system that closely resembles adults, but with different levels of training, fewer viruses, and fewer health problems.”
It is not uncommon for a 40-year-old person to experience fever and arm pain after being vaccinated, but these side effects may be more difficult for a 9-month-old person to tolerate.
“When we launch a vaccine campaign for our children, we really want to be thoughtful so that we can fully expect the pediatrician, and most importantly, the parents, to see what they see in a day or two after vaccination. “Mr. Kleech said.
Dr. Robert Frenck, director of the Vaccine Research Center at Cincinnati Children’s Hospital and a researcher at the Pfizer trial at the hospital, reviews the “symptomatology diary” that participants are required to keep.
“Children (if they have symptoms) have headaches and fatigue. They may have muscle aches, but not so many others,” Frenck said. “Most symptoms go away in a day or two. Many people have almost nothing.”
Some children infected with Covid-19 experienced MIS-C, or multi-organ inflammatory syndrome in their children. This is rare, but it can cause serious illness in some children.
“We will monitor it with particular interest to ensure that it can develop in the coming months, in connection with vaccines or in connection with vaccines and infections,” Kulich said. Stated. “There is no reason to think that it will happen with vaccines alone, but we are looking for it.”
Participants will also be closely monitored for rashes, fever, malaise, or other health problems.
Clinical trials of the Covid-19 vaccine are supervised by an independent expert data and safety monitoring committee (DSMB) that has access to study data and can recommend discontinuation of the study if safety concerns arise. I am.
Dr. Catherine Edwards is the Science Director of the Vanderbilt University Vaccine Research Program and a member of the DSMB of the Covid-19 vaccine tested in children.
“If children get sick, they will be seen by investigators to see if the illness may be related to the vaccine,” Edwards said. “Safety concerns will be paid close attention.”
How can children participate in the exam?
Plimpton said he had an enthusiastic reaction to Moderna’s call for participants in KidCOVE’s study, which aimed to enroll 6,750 participants in the United States and Canada.
“It’s amazing how much parents can come out and help clear this for their children,” said Primpton. “I told Moderna that I could probably welcome all 6,750 patients here in Phoenix, and they have 75 sites in the United States and Canada.”
Plimpton said the study has no specific demographic requirements, but the response is diverse, the study site is nationwide, and it includes a wide range of participants.
“Most of the time we’re getting everyone,” he said. “It’s happening because every parent wants to protect their child.”
Rachel Guthrie, a delivery nurse in Phoenix, Arizona, has registered her 3-year-old son and 2-year-old daughter in the moderna trial. She said she wanted to protect her children from any exposure she encountered and wanted her son to have some protection in his direct kindergarten. They are ready to receive their first shot this week.
“I jumped at the opportunity because I wanted my children to protect it,” she said. “Someone must be willing to get approval for this vaccination for children.”
Researchers hope that children aren’t the only ones to benefit from the exam.
“We also want research to give peace of mind that other demographic groups can be vaccinated.” Hey, this 6-month-old baby was vaccinated. Why am I 25 years old and not. Are you willing to do it? “Prinpton said.
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