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Saturday, March 15, 2025

FDA authorizes 1st COVID-19 shots for infants, preschoolers

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1002 days ago
20220617
FILE - Syringes and colorful bandages are prepared as children from local schools prepare to get COVID-19 vaccines in Pittsfield, Mass., on Monday Dec. 13, 2021. (Ben Garver/The Berkshire Eagle via AP, File)

FILE - Syringes and colorful bandages are prepared as children from local schools prepare to get COVID-19 vaccines in Pittsfield, Mass., on Monday Dec. 13, 2021. (Ben Garver/The Berkshire Eagle via AP, File)

 

By LIND­SEY TAN­NER-As­so­ci­at­ed Press

 

U.S. reg­u­la­tors on Fri­day au­tho­rized the first COVID-19 shots for in­fants and preschool­ers, paving the way for vac­ci­na­tions to be­gin next week.

The Food and Drug Ad­min­is­tra­tion’s ac­tion fol­lows its ad­vi­so­ry pan­el’s unan­i­mous rec­om­men­da­tion for the shots from Mod­er­na and Pfiz­er. That means U.S. kids un­der 5 — rough­ly 18 mil­lion young­sters — are el­i­gi­ble for the shots, about 1 1/2 years af­ter the vac­cines first be­came avail­able in the U.S. for adults, who have been hit the hard­est dur­ing the pan­dem­ic.

The FDA al­so au­tho­rized Mod­er­na’s vac­cine for school-aged chil­dren and teens. Pfiz­er’s shots had pre­vi­ous­ly been the on­ly ones avail­able for those ages.

There’s one step left: The Cen­ters for Dis­ease Con­trol and Pre­ven­tion rec­om­mends how to use vac­cines and its vac­cine ad­vis­ers are set to dis­cuss the shots for the youngest kids Fri­day and vote on Sat­ur­day. A fi­nal sig­noff would come from CDC Di­rec­tor Dr. Rochelle Walen­sky.

At a Sen­ate hear­ing Thurs­day, Walen­sky said her staff was work­ing over the June­teenth fed­er­al hol­i­day week­end “be­cause we un­der­stand the ur­gency of this for Amer­i­can par­ents.”

She said pe­di­atric deaths from COVID-19 have been high­er than what is gen­er­al­ly seen from the flu each year.

“So I ac­tu­al­ly think we need to pro­tect young chil­dren, as well as pro­tect every­one with the vac­cine and es­pe­cial­ly pro­tect el­ders,” she said.

For weeks, the Biden ad­min­is­tra­tion has been prepar­ing to roll out the vac­cines. States, tribes, com­mu­ni­ty health cen­ters and phar­ma­cies pre­ordered mil­lions of dos­es. FDA’s emer­gency use au­tho­riza­tion al­lows man­u­fac­tur­ers to be­gin ship­ping vac­cine across the coun­try. Vac­ci­na­tions could be­gin as ear­ly as Mon­day or Tues­day.

Some par­ents have been anx­ious­ly await­ing the chance to pro­tect their lit­tle ones.

While young chil­dren gen­er­al­ly don’t get as sick from COVID-19 as old­er kids and adults, their hos­pi­tal­iza­tions surged dur­ing the omi­cron wave and FDA’s ad­vis­ers de­ter­mined that ben­e­fits from vac­ci­na­tion out­weighed the min­i­mal risks. Stud­ies from Mod­er­na and Pfiz­er showed side ef­fects, in­clud­ing fever and fa­tigue, were most­ly mi­nor.

The two brands use the same tech­nol­o­gy but there are dif­fer­ences.

Pfiz­er’s vac­cine for kids younger than 5 is one-tenth of the adult dose. Three shots are need­ed: the first two giv­en three weeks apart and the last at least two months lat­er.

Mod­er­na’s is two shots, each a quar­ter of its adult dose, giv­en about four weeks apart for kids un­der 6.

The vac­cines are for chil­dren as young as 6 months. Mod­er­na next plans to study its shots for ba­bies as young as 3-months-old. Pfiz­er has not fi­nal­ized plans for shots in younger in­fants. A dozen coun­tries, in­clud­ing Chi­na, al­ready vac­ci­nate kids un­der 5.

Dr. Beth Ebel, pro­fes­sor of pe­di­atrics at Uni­ver­si­ty of Wash­ing­ton in Seat­tle, said the tot-sized vac­cines would be es­pe­cial­ly wel­comed by U.S. par­ents with chil­dren in day­care where out­breaks can side­line par­ents from jobs, adding to fi­nan­cial strain.

“A lot of peo­ple are go­ing to be hap­py and a lot of grand­par­ents are go­ing to be hap­py, too, be­cause we’ve missed those ba­bies who grew up when you weren’t able to see them,” Ebel said.

AP Med­ical Writ­ers Lau­ra Un­gar and Car­la K. John­son con­tributed.

 

 

COVID-19COVID-19 deathsFDACovid vaccines


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