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“I don’t think it will be long before we expand it to 12 to 15 – maybe in a few weeks to a month or so,” said Dr Bob Frenck, director of the hospital’s Vaccine Research Center. for children of Cincinnati.
However, parents are already asking for more information on approval or authorization for children under 12. Studies in this direction are in progress.
It appears that children can receive a much lower dose of the vaccine than adults and still get the same immune response, Frenck told CNN.
This is good news, because it means the vaccine supply can be stretched further, Frenck said.
“We took a step back after doing the teens, and we looked at the dosage because we thought we could maybe use a lower dose and get the same immune response,” Frenck said.
It appears that children aged 5 to 12 get a strong immune response with 10 micrograms of vaccine antigen, Frenck said.
“So a third of the dose that we give to adults, or even a third of the dose that was used in children 12 years and older, was just as immunogenic. We got an immune response just as good as the kids. 30- microgram dose and there were fewer side effects, ”he said.
“So because of that, for dosing in 5-12 year olds, we are looking for 10 micrograms, then in younger ones, less than 5 years old, even going up to 3 micrograms.”
It can be confusing, but it just means children have a stronger immune response, Frenck said. “It really proves that the immune responses of children are good. They are very strong,” he said.
“A lot of people ask us, ‘Does that mean you’re giving us less vaccines?’ I said, well, we give you less antigen, but their immune response is so good that they produce the same immune response – so there is no need to give more vaccine, ”Frenck added.
“We are giving enough vaccine to be able to get the same immune response we see in 25-year-olds who are given 30 micrograms.”
More is not better, said Frenck – the immune response peaks and giving a higher dose does not strengthen it.
“We were able to decrease by a third and still have the same immune response,” he said.
Like in adults, side effects are usually mild and don’t last long, Frenck said.
“The side effects that we see in children are really the same as what we see in adults,” Frenck said. This includes arm pain, fatigue, headaches and fever in about 10% of children, he said.
Dr Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, said he was confident the trials would show good efficacy in young children.
“I don’t think there’s any question of it being effective in children at this younger age. I have no doubts about that,” Fauci told CNN’s Anderson Cooper Monday night.
Dr Amanda Dropic, a pediatrician in Florence, Kentucky, has enrolled her four children in trials for different ages at Cincinnati Children’s.
“I told my kids about it. We all agreed that in order for everyone to get vaccinated, someone has to be ready to step in and go first,” she said in a video posted by the hospital.
“We miss travel. We miss vacations. We miss concerts. We miss sports activities. So I hope our children get vaccinated and others get vaccinated, that will really help,” Dropic said.
“I can’t wait to go out with friends (…) -15 years old.
“Getting the vaccine is important to stop the spread of the coronavirus and so the virus won’t hurt anyone again,” said Ben’s younger brother Eli, 10.
Frenck’s team is starting vaccine trials now testing Moderna’s Covid-19 vaccine in children under 12. The hospital needs to enroll 75 children, he said – 25 in each age group: 6-12, 2-6 and infants up to 2 years old.
As with all coronavirus vaccine trials, investigators like Frenck are speeding up bureaucratic vaccine data submission steps in order to move the process forward faster.
“Typically what happens is you get a result of a phase 1 (trial) and then you show it to the company and say, ‘Okay, is that enough for we were going into a phase 2, “And then you have to think about it. And then you have the same with phase 2 to phase 3. Here it just moved forward because the funding was already available,” he said. he declares.
Often a study lasts four or five years, and researchers collect all the data at the end of that study period and submit it to the FDA. “So you can imagine getting four or five years of data all at once – that’s a lot to try to process,” he said.
“What happened here was that the FDA was receiving packets of information in real time. As companies got the information, it was submitted to the FDA for review. clearance, the FDA was already very familiar with the products and they didn’t have to start from scratch. “
Moderna is also considering lower doses in young children, Frenck said.
Pfizer has announced that it will seek FDA clearance to use its vaccines in children aged 5 to 11 by the end of September, once all data is submitted.
Moderna, whose vaccine is licensed for people 18 years of age and older, has applied for EUA for children 12 to 17 years old. He expects to have data on young children later this year.
Johnson & Johnson is in “active discussions with regulatory authorities regarding our development plan and trial designs” for adolescents and children and expects to begin trials in the fall.
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