From now on there would be no excuse not to get vaccinated 1:03
(CNN) -
The U.S. Food and Drug Administration (FDA) has granted full approval for Pfizer's covid-19 vaccine for people 16 years of age and older.
It is expected to be approved soon for children ages 12-15.
"I don't think it will be long before they expand to 12-15 years, maybe in a few weeks or a month or so," said Dr. Bob Frenck, director of the Vaccine Research Center at Children's Hospital of Cincinnati.
FDA Warns Against Unauthorized Use of Pfizer / BioNTech Covid-19 Vaccine in Children Under 12 Years of Age
However, parents are already asking for more information on approval or authorization for children under 12 years of age.
Studies are being carried out in this regard.
It appears that children can receive a much smaller dose of 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 expanded further, Frenck said.
"After vaccinating adolescents, we focused on the dose, because we thought we could use a lower dose and get the same immune response," said Frenck.
Children, with a better immune response
It appears that children ages 5 to 12 get a strong immune response with 10 micrograms of antigen, Frenck said.
advertising
7 Ways to Support Kids' Immune Systems as They Go Back to School and Await the Covid-19 Vaccine
"So a third of the dose that we are giving to adults, or even a third of the dose that was used in children 12 and older, was just as immunogenic. We got as good an immune response as the 30 microgram dose. and there were fewer side effects, "he said.
"For this reason, for the dose of 5 to 12 years we are considering 10 micrograms, and then, in the youngest children, under 5 years, even lower it, up to 3 micrograms."
This can be confusing, but it simply means that children have stronger immune responses, Frenck said.
"This really shows that children's immune responses are good. They are very strong," he said.
More is not better
"A lot of people ask us: 'Does this mean that they are giving us fewer vaccines? I said: well, we are giving them less antigen, but their immune response is so good that they are giving the same immune response, so there is no need to give more vaccine, "added Frenck.
"We are giving enough vaccine to be able to get the same immune response that we see in 25-year-olds who get 30 micrograms."
Experts hope to expand the protection of vaccines for children and immunosuppressed people to win the race against the variants
More is not better, Frenck said: The immune response peaks and giving a higher dose not potency.
"We were able to drop by a third, and we still got the same immune response," he said.
As in the case of adults, the side effects are usually mild and do not last long, Frenck said.
"The side effects that we see in children are really identical to those in adults," Frenck said.
This includes arm pain, fatigue, headache and fever in about 10% of children, he added.
Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, said he was confident the trials would show good efficacy among younger children.
"I don't think there is any doubt that this is going to be effective in children of that younger age. I have no doubt about it," Fauci told CNN's Anderson Cooper on Monday night.
FDA Provided Full Approval Details for Pfizer / BioNTech Covid-19 Vaccine
Dr. Amanda Dropic, a pediatrician from Florence, Kentucky, enrolled her four children in trials for varying ages at Cincinnati Children's Hospital.
"I talked to my kids about it. We all agreed that for everyone to get vaccinated, someone has to be willing to step up and be the first," he said in a video posted by the hospital.
"We miss trips. We miss vacations. We miss concerts. We miss sports activities. So we hope that as our children get vaccinated and other people get vaccinated, it will be of great help," he said. Dropic.
"I just want to go out with my friends ... to go places without worrying about masks or where I can eat," said Dropic's son, Ben, who is now 16 years old, and who participated in the trial. Pfizer's Covid-19 vaccine, in the 12-15 year age group.
"It's important to get vaccinated to stop the spread of the coronavirus and so the virus doesn't harm more people," said 10-year-old Ben's younger brother Eli.
What Parents Need to Know About Vaccination for Children 12-15 Years
How the rehearsals continue
Frenck's team is now beginning trials of Moderna's covid-19 vaccine in children under 12 years of age.
The hospital plans to enroll 75 children, he said, 25 in each age group: 6-12, 2-6 and babies up to 2 years old.
As in all coronavirus vaccine trials, researchers like Frenck are speeding up bureaucratic steps to submit vaccine data to streamline the process.
"Typically what happens is you get a result of a phase 1 (test) and then you show it to the company and say, 'Okay, is that good enough to go to phase 2?' And then the same from phase 2 to phase 3. In this case, everything has gone smoothly because the financing was already available, "he said.
Full FDA approval of COVID-19 vaccine could lead to more people getting vaccinated for an unexpected reason
Often a study lasts four or five years, and the researchers gather all the data at the end of that study period and submit it to the FDA.
"So you can imagine that getting four or five years of data in one go is a lot to try to process," he said.
"What happened here was that the FDA received packets of information in real time. As companies obtained the information, it was presented to the FDA for review. So when it was time to review the authorization for use In an emergency, the FDA was already very familiar with the products and didn't have to start from scratch. "
Moderna is also considering using lower doses in young children, Frenck said.
Pfizer says it will apply to the FDA for authorization to use its vaccines in children ages 5 to 11 at the end of September, once all the data is submitted.
Moderna, whose vaccine is licensed for people over 18 years of age, has applied for emergency use authorization for children 12 to 17 years of age.
He hopes to have data on younger 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.
covid-19 vaccine