Washington: In a move closer to expanding the COVID-19 vaccinations for children, government advisers in the United States have endorsed kid-size doses of Pfizer’s shots for 5- to 11-year-olds. A Food and Drug Administration advisory panel voted unanimously, with one abstention, that the vaccine’s benefits in preventing COVID-19 in that age group outweigh any potential risks. That includes questions about a heart-related side effect that’s been very rare in teens and young adults despite their use of a much higher vaccine dose.Also Read - Omicron Threat: Pfizer Working on Updated Vaccine in Response to New Covid Variant
While children are far less likely than older people to get severe COVID-19, ultimately many panelists decided it’s important to give parents the choice to protect their youngsters — especially those at high risk of illness or who live in places where other precautions, like masks in schools, aren’t being used. Also Read - Pfizer's COVID Vaccine Gets European Union’s Approval For Use on Kids Aged Between 5-11
“This is an age group that deserves and should have the same opportunity to be vaccinated as every other age,” said panel member Dr. Amanda Cohn of the Centers for Disease Control and Prevention. Also Read - Pill to Treat COVID-19 Likely to be Approved for Emergency Use Within Few Days in India; To be Priced ₹ 2000- ₹ 4000 Initially
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.
Pfizer studied 2,268 elementary schoolchildren given 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. More important, the vaccine proved nearly 91% effective at preventing symptomatic infection — based on 16 cases of COVID-19 among kids given dummy shots compared to just three who got vaccinated.
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.
But that study isn’t large enough to detect any extremely rare side effects, such as the heart inflammation that occasionally occurs after the second full-strength dose, mostly in young men and teen boys. The panel spent hours discussing if younger children, given a smaller dose, might face that side effect, too.
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 rare heart problem.
FDA’s models suggested the vaccine could prevent 200 to 250 hospitalizations for every 1 million youngsters vaccinated — assuming that virus spread remained high, something that’s hard to predict. FDA scientists also said younger kids likely won’t have as much risk of heart inflammation as teens but if they did, it might cause about 58 hospitalizations per million vaccinations.
“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.”
Moderna also is studying its vaccine in young children, and Pfizer has additional studies underway in those younger than 5.
(With AP inputs)