What if Asking for a Child’s Vaccine Was the Easy Part?

This morning, Pfizer / BioNTech submitted the Food and Drug Administration data from a clinical trial of a Covid vaccine for children, launching a process that can give doses to children between 5 and 11 within a month or two.

With the increase in child cases – last week, those under the age of 18 done nearly 27 percent of the newly reported cases, according to the American Academy of Pediatrics, even though they only represent 22 percent of the U.S. population-there is a lot of pressure to act on regulation immediately. Even parents who wait patiently for this moment may find more obstacles in their way than they expected. As complicated as it used to be, getting vaccinated is part of the challenge of protecting children. Getting it delivered and served can be complicated as well.

For one thing, the new shots come in a system that is even more numerous. “Immunization programs don’t even have a second to think about this group, because they have agreed to vaccinate adults, and additional doses for the period of immunization, and the period of flu vaccination, which can’t be avoided, ”said Kelly Moore, a physician and president and CEO of the nonprofit Immunization Action Coalition. “They don’t catch their breath, which is a problem, because it comes so fast.”

Although the shots will also be delivered to children in different locations, likely by different staff, than the adult vaccines released last winter. They are coming to a national scene that is more political than ever. And it’s also not clear how many Americans welcomed them: A Gallup poll was released just this morning found that 45 percent of parents do not plan to vaccinate their young children.

A review of where we are in the shot and kids: Let’s point out, first, that all of these plans are aimed solely at Pfizer / BioNTech, the only manufacturer where the tests have advanced enough forward to allow the child to be vaccinated. Their vaccine has had a completely new FDA drug approval since August, but only for ages 16 and up; for children 12 to 15, the vaccine remains used in an emergency, and children as young as 12 have never received it.

Pfizer is pursuing clinical trials aims to clear the vaccine for young children from March. An estimated 4,500 children were in the trials divided into three cohorts: 6 months to 23 months, 2 years to just 5, and 5 to 11. In each group, the tested vaccine was partially in the adult dose, from one -third to one -tenth. Last week, the company made its first comment about it child test outcomes, stating that the two phases of a third dose achieve the same antibody levels at about 5 to 11 years of age as did the two full-dose doses of 16 to 25- anyos. These are the results, with a lot of data, that the company is bringing to the FDA today. Data for minors under 5 should be followed.

(Some manufacturers have not yet reached their tests. Moderna’s vaccine has emergency use approval for ages 18 and older, and is awaiting full approval for adults and approval for young people.) teenager.The company began studying children younger than 12 in August. J&J, a single -dose vaccine, is behind two other companies in its research; it also has an emergency permit that only applies to adults.)

Since last summer, Pfizer, regulators, and business analysts have had speaks all that they expect the first approval to come by the end of October or November. That estimate still looks solid, if optimistic. The timeline is wiggly, because no one outside the FDA knows how quickly the agency will review what can be complex data sets covering effectiveness, safety, and impacts. . Two independent committees, advisory to the FDA and the Centers for Disease Control and Prevention, will have to weigh in afterwards, and no one outside their ranks will be able to say how they will review that data. (That’s the two committees that met the last two weeks so far discuss and finally agree booster shots for many Americans.)

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