Is it easy to approve a vaccine for children?

This morning, Pfizer / Biotech Clinical trials of a covid vaccine for children have submitted data to the Food and Drug Administration, launching a process that could deliver doses to children aged 5 to 11 in the next month or two.

According to the American Academy of Pediatrics, in the case of children growing up last week, under-18s make up about 27 percent of newly reported cases, even though they represent only 22 percent of the U.S. population অনেক there is a lot of pressure to get there quickly. But parents who are desperately waiting for this moment may get more frustrated than they expected. As complicated as it may be, getting the vaccine approved is just one part of the child protection challenge. It will also be complicated to distribute and manage.

For one thing, the new shots will come in a system that is already overwhelmed. “Immunization programs have not yet had time to think about this group, as they are working on adult vaccinations, and immunocompromised, and influenza vaccination season overdoses, which cannot be postponed,” said Kelly Moore, a physician and nonprofit. President and CEO. “They weren’t able to breathe, which is a problem, because it’s coming fast.”

But those shots will be delivered to children in different winters, probably by different staff, than in the adult vaccine last winter. They are arriving in a national territory that is more political than ever. And it’s not clear how many Americans welcome them: a Gallup poll released this morning found that 45 percent of parents do not plan to vaccinate their young children.

A summary of where we shot and the kids. Let’s first make it a condition that all of these plans address Pfizer / Biotech only, the only manufacturer whose tests have gone far enough to allow child vaccinations. Their vaccines have received full FDA approval of new drugs since August, but only for those 16 years and older; For children 12 to 15 years old, the vaccine is under emergency use, and children under 12 years of age have not been able to receive it at all.

Pfizer has been conducting clinical trials since March aimed at clearing the vaccine in young children. Tri month to 2 months month; Just under 5 years from 2 years; And 5 to 11. In each group, some portions of the tested vaccine adult dose, one-third to one-tenth. Last week, the company first commented on its pediatric trial results, saying that two rounds of one-third doses achieved the same antibody levels in 5- to 11-year-olds as two full-dose doses for 16- to 25-year-olds. These results, along with much more data that the company brought to the FDA today. Information should be followed for under-15s.

(Other manufacturers have not yet come to their tests. The modern vaccine has been approved for emergency use for 18 years of age or older, and is awaiting full approval for adults and young adults. The company began research on children under 12 in August. J&J, single Dose Vaccine is behind two other companies in its research; it still has only one emergency approval that covers adults only.)

Since last summer, Pfizer, regulators and business analysts have all said they expect the first approvals to arrive in late October or November. If optimistic, that assumption still looks solid. The timeline is vague, as no one outside the FDA knows how quickly the agency will review complex data sets, including efficacy, safety, and side effects. Advisers from the two independent committees, the FDA and the Centers for Disease Control and Prevention, must weigh in next, and no one outside of their ranks will be able to say how much they think. (These are the two committees that met in the last two weeks to discuss and finally approve booster shots for a wider section of Americans.)

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