This morning, Pfizer/BioNTech Presenter The data is back to the Food and Drug Administration from its clinical trial of a children’s Covid vaccine, launching a process that could deliver doses to children between 5 and 11 within the next month or two.
As children’s cases rise – last week, those under the age of 18 Consisting of Roughly 27 percent of newly reported cases, according to the American Academy of Pediatrics, even though it represents only 22 percent of the U.S. population — there’s a lot of pressure to move quickly through regulation. But parents who have been eagerly waiting for this moment may find more obstacles in their way than they expect. As complicated as it was, getting the licensed vaccine was just part of the challenge of protecting children. Obtaining, distributing and managing it would also be complicated.
For one thing, new picks will arrive in an already overwhelmed system. “Immunization programs haven’t had a second to think about this group yet, because they’ve been dealing with adult vaccination, extra doses for the immunocompromised, and flu vaccination season, which cannot be postponed,” says Kelly Moore. Physician, President and CEO of the nonprofit Immunization Action Coalition. “They couldn’t catch their breath, and that’s a problem, because it comes so fast.”
But these shots will also be delivered to children in different locations, likely by different individuals, than the adult vaccines launched last winter. They are arriving at a national scene that has become more politicized than it was before. And it’s not even clear how many Americans would welcome them: a Gallup poll released only this morning It found that 45 percent of parents do not plan to vaccinate their young children.
A summary of what we are up to in Snaps and Babies. Suppose, first, that all of these plans deal only with Pfizer/BioNTech, the only manufacturer whose trials have advanced far enough to allow children to be vaccinated. Their vaccine has received full new FDA approval since August, but only for ages 16 and up; For children aged 12 to 15, the vaccine remains in emergency use, and children under 12 have never been able to receive it.
Pfizer was following Clinical trials It aims to remove the vaccine for younger children since March. The 4,500 children in those trials were divided into three groups: 6 months to 23 months; 2 years to just under 5 years; and 5 to 11. In each group, the vaccine being tested is part of the adult dose, one-third down to one-tenth. Last week, the company provided its first comment on Pediatric trial results, saying that two of those two-thirds rounds of doses achieved the same antibody levels in children aged 5 to 11 as did two full doses in children aged 16 to 25. These results, along with a lot of data, are what the company brought to the U.S. Food and Drug Administration (FDA) today. It is meant to track data for children under the age of five.
(Other manufacturers haven’t gone that far in their trials. Moderna’s vaccine has an emergency use authorization for ages 18 and over, and is awaiting full approval for adults and authorization for younger teens. The company has begun studies in children younger than 12 years old. in August. J&J, the single-dose vaccine, is behind the other two companies in its research. He still has an emergency only pass that covers adults only.)
Since last summer, Pfizer, regulators and business analysts All he was saying They hope the first permission will arrive in late October or November. This estimate still looks strong, if optimistic. The schedule is fluctuating, because no one outside the FDA knows how quickly the agency will review potentially complex data sets, covering efficacy, safety and side effects. Two independent committees, advisers to the Food and Drug Administration and the Centers for Disease Control and Prevention, must then influence, and no one outside their ranks can say how well they think about examining this data. (These two committees that met in the past two weeks for discussion And in the end Approves Booster shots for a wide range of Americans.)