FDA Authorizes Pfizer Covid-19 Vaccine for Kids Age 5 to 11

The U.S. Food and Drug Administration has now empower the first covid-19 vaccinum for children between the ages of 5 and 11 . The authority will cover the Pfizer / BioNTech mRNA vaccine , though the Centers for Disease Control and Prevention will have to give their benediction next week before the vaccinum can be widely available .

The authorization comes after a nearly unanimous endorsement from an FDA advisory commission that encounter earlier this week to discuss the vaccinum . During that meeting , data was presented from a trial run of 3,100 kid present the vaccine , who were equate to children reach placebo . The tryout showed that small fry ’s resistant response were interchangeable to the resistant responses seen in untested the great unwashed between the historic period of 16 and 25 , and the vaccine was reckon to be 90.7 % effective at preventing covid-19 . Furthermore , no serious adverse upshot connect to the vaccine were report , though one shaver was noted to have feed a penny in anunrelated incident .

“ As a female parent and a doc , I know that parents , caregivers , shoal staff , and children have been wait for today ’s mandate . immunise younger children against COVID-19 will contribute us closer to returning to a sentiency of normalcy , ” said acting FDA commissioner Janet Woodcock in astatementfrom the FDA . “ Our comprehensive and tight valuation of the data pertaining to the vaccinum ’s safety and effectuality should help assure parents and guardians that this vaccine meets our in high spirits standards . ”

Photo: Cindy Ord (Getty Images)

The child version of the vaccine will come in a smaller dose than the version for adult . But it will similarly be offered as a two - dose shot given over a three - calendar week catamenia .

Though there were no serious adverse event detected during the visitation , usual side effects did admit injection site pain in the neck , inflammation and swelling , fatigue , and headache . wellness official also noted that rare side event previously documented in younger recipients , peculiarly myocarditis ( heart inflammation ) , may appear once the vaccine is dole out widely . But in modeling various scenario of the pandemic ’s near future , FDA researchers close that the benefits of vaccination in preventing covid-19 would still outweigh its risk . Notably , several study have estimated covid-19 to have ahigher riskof make myocarditis than the vaccine . And while younger nipper have rarely snuff it from covid-19 , it has still been a leadingcause of deathin that age grouping .

The FDA ’s authorization is only the first stride needed for children to encounter the vaccine . Early next week , the CDC ’s consultive committee will meet to discuss the precise guideline for administration , after which the CDC is expected to give their green light . Earlier this week , Modernareleasedpromising results from its own trial of young children and is expected to file for authorization shortly .

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