DORAL, FL – Pfizer vaccine in its kid-size dose has been endorsed by FDA panel on Tuesday. The Food and Drug Administration is expected to make a final decision on the matter within days.
The pharmaceutical company joins Moderna in the list of vaccines backed by the FDA panel for kids and now both vaccines are awaiting final approval although Moderna’s vaccine showed it produces strong immune response in children ages 6 to 11 in interim data.
Full-strength shots made by Pfizer and its partner BioNTech already are recommended for everyone 12 and older but younger kids are still not protected amid a pandemic that doesn’t seem to go away in the short term, now even less considering delta variant has caused an alarming rise in pediatric infections.
The final approval for the shots aimed at younger children has to come not only from the FDA but also from the Centers for Disease Control and Prevention that must determine if Pfizer vaccine is appropriate for this age group and which youngsters should access to it.
The advisory panel voted unanimously with one abstention which is that the vaccine’s benefits in preventing COVID-19 in that age group outweigh any potential risks.
“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,” said FDA adviser Jeannette Lee of the University of Arkansas.
“I do think it’s a relatively close call,” said adviser Dr. Eric Rubin of Harvard University. “It’s really going to be a question of what the prevailing conditions are but we’re never going to learn about how safe this vaccine is unless we start giving it.”
About how safe it would be versus reducing pediatric cases of COVID-19, a study of elementary school children found the Pfizer shots are nearly 91% effective at preventing symptomatic infection considering 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. Those vaccinated developed levels of virus-fighting antibodies just as strong as teens and young adults who got the full-strength shots.
In addition, side effects found in young children are similar or fewer compared with those experienced by teens, although the study isn’t large enough to detect any extremely rare side effects.