This morning, Pfizer / Biotech Submitted Data from the Clinical Trials of a Covid Vaccine for Children to the Food and Drug Administration, introducing a mechanism that could deliver doses to children 5 to 11 years of age within the next month or two.
Last week, in the case of children under the age of 18 Formed According to the American Academy of Pediatrics, about 2 percent of newly reported cases, although they represent only 22 percent of the U.S. population-there is a lot of pressure to move forward through rapid control. But parents who are anxiously awaiting this moment may find it more difficult than they expected. As complicated as it may be, getting vaccinated 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 also not clear how many Americans welcome them: a Gallup poll has been published Just 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 continues to chase Clinical trials The goal is to clear the vaccine for young children from March. 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 made its first comment on it Pediatric trial results, Saying that two rounds of one-third dose achieved the same antibody levels in 5- to 11-year-olds as two full-dose doses in 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 has begun research on children under 12 years of age.) In August. J&J, the single-dose vaccine, lags behind the other two companies in its research; It still only has an emergency authorization that only covers adults.)
Since last summer, there have been Pfizer, regulators and business analysts All said They expect the first approval to come 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 a company will review complex data sets that have 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 two committees met in the last two weeks To discuss And in the end Approval Booster shots for the vast majority of Americans.)