Lthe Food and Drug Administration, an agency of the American Department of Health, has given emergency authorization for the use of the Pfizer vaccine for Covid on children aged 12 to 15 and has scheduled a meeting for next month to discuss the possible authorization under 12 years. Robert Frenck directs the Gamble Vaccine Research Center at Cincinnati Children’s Hospital in Ohio, one of ten National Institute of Health-funded centers that test vaccines, and one of the top five sites that have tested Pfizer vaccines on 12-15 year olds.
A total of 2,260 children participated in the Pfizer study of 12-15 year olds – much lower numbers than adults. Why?
“Those on adolescents and children are integrative studies, in which their immune response is compared to that of adults. We do not know the so-called correlated immunity, i.e. how high the immune response must be to be protected, but we do know that with a certain immune response, adults are experiencing a certain level of effectiveness of the vaccine. It follows that if adolescents have the same immune response they will have the same protection. Since Covid is so widespread among adolescents, with a tenth of the participants compared to the adult study, we were able to prove the effectiveness of the vaccine: it proved incredibly protective, the side effects are mild. In the half that received the placebo there were 18 cases; zero in the group that received the vaccine ».
Have you given the same doses as adults to children between 12 and 15 years old?
“Yup. The side effects were the same and the same dose could be used, but we also measured the immune response – how the body responds to vaccines and the amount of antibodies it generates – and we saw that the 12 to 15 year old group has a significantly greater immune response, even compared to 16-17 year olds ».
Will you also use the same doses in the tests you are doing now with the little ones?
“We will take a step back, starting to give lighter doses, by a quarter or a third, observing the side effects and, hopefully, gradually increasing, potentially to the level used for adults. We have three groups: between 5 and 11 years, between 2 and 4 years and between six months and 2 years. For example, if I use 10 micrograms of the vaccine in the 5 to 12 year old group and there is no problem, I will go to 20 micrograms, and if I experience too many side effects, I will not use that dose in the 2 to 5 year old group but only the dose of 10. So we could find ourselves studying three doses between 5 and 12 years, only two between 2 and 5 years and one dose between 6 months and two years. With the flu vaccine, the dose administered to a six-month-old baby is the same as that of a 64-year-old while at 65 it increases because the immune system does not work as well. Maybe we will eventually use the same doses for Covid too, but we want to take a step back and evaluate. Even for young adults, smaller doses may be sufficient, because their immune systems are stronger, but when you are in a pandemic try to give everyone the same dose if it is safe. Make adjustments later, trying to reduce the dose to avoid side effects. But at the moment, from a logistical point of view, it helps to have the same dose for all ages, so as not to have to keep them separate and prevent administration errors ».
Are the side effects between 12-15 year olds greater?
“For the next 7 days the boys recorded in a diary if they had headaches, muscle aches, fever … Practically identical to those found in the twenties.”
Why is it important to vaccinate children and young people?
“When the pandemic started it was said that children were not infected, but I never believed it. It’s just that they weren’t tested. Today, children and adolescents have some of the highest rates of infections. Although the severity rate is much lower, it is not zero: about 300 children have died of Covid in the United States. There are two reasons for vaccinating them: one direct, that is, to protect them; 300 deaths out of 500 thousand is nothing, except if you are one of the parents of those 300 and, then, that’s all. The second reason is the indirect effect: in the United States there are people who are politicizing Covid. If you vaccinate children maybe you can stop the spread among unvaccinated adults. ”
May 11, 2021 (change May 11, 2021 | 21:45)
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