Pfizer Vaccine a Step Closer to Being Available for Kids 5 to 11 After Panel Gives OK

A Food and Drug Administration (FDA) advisory panel approved Pfizer's COVID-19 vaccine for kids ages 5 to 11 on Tuesday, moving the vaccine on to the next step in the authorization process, the Associated Press reported. The FDA does not have to follow the panel's guidance but is expected to announce its own decision within the next few days. If the agency does give its approval to the vaccine, the Centers for Disease Control and Prevention then must decide next week whether to recommend the shots and what children should be able to receive them, the AP reported. The advisory panel voted unanimously to endorse the vaccine with one abstention that the vaccine's capability to prevent infection outweighs any risks in getting the shot. This includes a heart-related side effect detected very rarely in teenagers and young adults who got the regular, larger dose of the Pfizer's vaccine, according to the AP. Though the risks of contracting severe COVID-19 aren't as high for children as they are for older people, the panelists determined that it was necessary to provide children with the option of getting extra protection against the virus. Jeannette Lee, an FDA adviser from the University of Arkansas, said that the virus is "not going away." "We have to find a way to live with it and I think the vaccines give us a way to do that," Lee said. For more reporting from the Associated Press, see below:

Full-strength shots made by Pfizer and its partner BioNTech already are recommended for everyone 12 and older but pediatricians and many parents are clamoring for protection for younger children. The extra-contagious Delta variant has caused an alarming rise in pediatric infections—and families are frustrated with school quarantines and having to say no to sleepovers and other rites of childhood to keep the virus at bay. States are getting ready to roll out shots for little arms—in special orange-capped vials to distinguish them from adult vaccines—as soon as the government gives the OK. More than 25,000 pediatricians and other primary care providers have signed up so far to offer vaccination. While there is less COVID-19 among 5- to 11-year-olds, they still have faced substantial illness—including over 8,300 hospitalizations reported, about a third requiring intensive care, and nearly 100 deaths.

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A study of elementary schoolchildren found the Pfizer shots are nearly 91 percent effective at preventing symptomatic infection—even though the youngsters received just a third of the dose given to teens and adults. Pfizer's study tracked 2,268 children ages 5 to 11 who got two shots three weeks apart of either a placebo or the kid dose. Vaccinated youngsters developed levels of virus-fighting antibodies just as strong as teens and young adults who got the full-strength shots. The kid dosage also proved safe, with similar or fewer temporary side effects—such as sore arms, fever or achiness—that teens experience. At FDA's request, Pfizer more recently enrolled another 2,300 youngsters into the study, and preliminary safety data has shown no red flags. The study isn't large enough to detect any extremely rare side effects, such as the heart inflammation that occasionally occurs after the second dose, mostly in young men and teen boys. Statistical models developed by FDA scientists showed that in most scenarios of the continuing pandemic, the vaccine would prevent far more COVID-19 hospitalizations in this age group than would potentially be caused by that very rare side effect, heart inflammation, that's the big unknown. But with cases falling across the U.S., the FDA panel had to consider whether the pandemic might recede so much that more children could face side effects from the vaccine than would be protected from COVID-19. "If the trends continue the way they are going then the emergency for children is not what we might think it might be," said Dr. James Hildreth of Meharry Medical College. Moderna also is studying its vaccine in young children, and Pfizer has additional studies underway in those younger than 5.