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Saturday, March 15, 2025

US: Pfizer COVID-19 shot appears effective for kids under 5 

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1006 days ago
20220613
FILE - Syringes and colourful bandages are prepared as children from local schools prepare to get COVID-19 vaccines in Pittsfield, Mass., on Monday Dec. 13, 2021. A review by federal health officials finds that Pfizer's COVID-19 vaccine appears safe and effective for children under 5, the only group not currently eligible for vaccination. The review issued Sunday, June 12, 2022, by the Food and Drug Administration is a key step toward a decision on vaccinations for babies, toddlers and pre-schoolers, perhaps as soon as June 21. (Ben Garver/The Berkshire Eagle via AP, File)

FILE - Syringes and colourful bandages are prepared as children from local schools prepare to get COVID-19 vaccines in Pittsfield, Mass., on Monday Dec. 13, 2021. A review by federal health officials finds that Pfizer's COVID-19 vaccine appears safe and effective for children under 5, the only group not currently eligible for vaccination. The review issued Sunday, June 12, 2022, by the Food and Drug Administration is a key step toward a decision on vaccinations for babies, toddlers and pre-schoolers, perhaps as soon as June 21. (Ben Garver/The Berkshire Eagle via AP, File)

By MATTHEW PER­RONE and MIKE STO­BBE | AS­SO­CI­AT­ED PRESS

 

WASH­ING­TON (AP) — Fed­er­al health of­fi­cials said Sun­day that kid-sized dos­es of Pfiz­er’s COVID-19 vac­cines ap­pear to be safe and ef­fec­tive for kids un­der 5, a key step to­ward a long-await­ed de­ci­sion to be­gin vac­ci­nat­ing the youngest Amer­i­can chil­dren.

The Food and Drug Ad­min­is­tra­tion post­ed its analy­sis of the Pfiz­er shot ahead of a Wednes­day meet­ing where out­side ex­perts will vote on whether the shots are ready for the na­tion’s 18 mil­lion ba­bies, tod­dlers and pre-school­ers. Kids un­der 5 are the on­ly group not yet el­i­gi­ble for COVID-19 vac­ci­na­tion in the U.S.

Late last week the FDA post­ed a sim­i­lar analy­sis of Mod­er­na’s shots for chil­dren un­der 6.

If reg­u­la­tors clear the shots by one or both com­pa­nies, vac­ci­na­tions could be­gin as soon as next week with the drug­mak­ers ready to rapid­ly ship dos­es or­dered by the gov­ern­ment. Par­ents have been press­ing fed­er­al of­fi­cials for months for the op­por­tu­ni­ty to pro­tect their small­est chil­dren as more adults shed masks and aban­don oth­er pub­lic health pre­cau­tions.

While on­ly about 3% of U.S. COVID cas­es are in the age group 6 months to 4 years, hos­pi­tal­iza­tion and death rates in that group are high­er than those for old­er chil­dren, ac­cord­ing to the FDA’s analy­sis — one rea­son ex­perts have said pro­tect­ing this group is im­por­tant.

The FDA said chil­dren who re­ceived Pfiz­er’s shots dur­ing test­ing de­vel­oped high lev­els of virus-fight­ing an­ti­bod­ies ex­pect­ed to pro­tect them against coro­n­avirus. That’s the ba­sic thresh­old need­ed to win FDA au­tho­riza­tion. But ad­di­tion­al test­ing turned up key dif­fer­ences, with stronger re­sults for Pfiz­er.

Pfiz­er’s vac­cine, giv­en as a three-shot se­ries, ap­peared 80% ef­fec­tive in pre­vent­ing symp­to­matic COVID-19, al­though that cal­cu­la­tion was based on just 10 cas­es di­ag­nosed among study par­tic­i­pants. The fig­ure could change as Pfiz­er’s study con­tin­ues.

Mod­er­na’s two-dose se­ries was on­ly about 40% to 50% ef­fec­tive at pre­vent­ing milder in­fec­tions, though the two com­pa­nies’ shots were test­ed at dif­fer­ent times dur­ing the pan­dem­ic, when dif­fer­ent vari­ants were cir­cu­lat­ing. Mod­er­na has be­gun test­ing a boost­er for tots.

On Wednes­day, the FDA will ask an in­de­pen­dent pan­el of vac­cine ex­perts to de­bate both com­pa­nies’ da­ta be­fore vot­ing. The FDA is not re­quired to fol­low the group’s rec­om­men­da­tions, but the process is seen as a key step in pub­licly vet­ting the shots.

The FDA is ex­pect­ed to make its of­fi­cial de­ci­sion short­ly af­ter Wednes­day’s all-day meet­ing. The next step: the Cen­ters for Dis­ease Con­trol and Pre­ven­tion, which rec­om­mends how to use vac­cines, will con­vene its own ex­pert pan­el to de­bate which tots need vac­ci­na­tions.

It’s not clear how much de­mand there will ini­tial­ly be for the shots. A re­cent sur­vey sug­gests on­ly 1 in 5 par­ents of young chil­dren would get their kids vac­ci­nat­ed right away. Vac­cines have been avail­able since No­vem­ber for old­er U.S. school­child­ren, yet less than a third of those ages 5 to 11 have got­ten the two rec­om­mend­ed dos­es, ac­cord­ing to gov­ern­ment fig­ures.

For the youngest chil­dren, each com­pa­ny is of­fer­ing dif­fer­ent dose sizes and num­ber of shots, be­gin­ning at 6 months through 4 years for Pfiz­er and through 5 years for Mod­er­na.

Pfiz­er and its part­ner BioN­Tech plan to of­fer two shots three weeks apart fol­lowed by a third at least two months lat­er — each one-tenth the dose giv­en to adults. Pfiz­er is cur­rent­ly the on­ly com­pa­ny with a COVID-19 vac­cine for old­er U.S. chil­dren.

Mod­er­na is seek­ing FDA clear­ance for two shots, each a quar­ter of its adult dose, giv­en about four weeks apart.

The FDA cur­rent­ly al­lows Mod­er­na’s vac­cine to be used on­ly in adults. But some coun­tries al­low full-size dos­es for teens and half-size shots for kids ages 6 to 11 — a step the FDA al­so is con­sid­er­ing.

More than 30,000 U.S. chil­dren younger than 5 have been hos­pi­tal­ized with COVID-19 and near­ly 500 coro­n­avirus deaths have been re­port­ed in that age group, ac­cord­ing to U.S. health of­fi­cials.

The gov­ern­ment al­lowed phar­ma­cies and states to start plac­ing or­ders for tot-sized dos­es last week, with 5 mil­lion ini­tial­ly avail­able — half made by Pfiz­er and half by Mod­er­na.

____

The As­so­ci­at­ed Press Health and Sci­ence De­part­ment re­ceives sup­port from the Howard Hugh­es Med­ical In­sti­tute’s De­part­ment of Sci­ence Ed­u­ca­tion. The AP is sole­ly re­spon­si­ble for all con­tent.

COVID-19United StateschildrenPfizerUnited States of AmericaCovid vaccines


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