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Monday, March 3, 2025

Marathon US hearings to decide fate of COVID shots for tots

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997 days ago
20220610
This combination of 2022 and 2020 file photos shows logos for the U.S. Centers for Disease Control and Prevention and the Food and Drug Administration. On Wednesday, June 15, 2022, both Moderna and Pfizer will have to convince what’s essentially a science court -- advisers to the Food and Drug Administration -- that their shots work well in babies, toddlers and pre-schoolers. If the FDA’s advisers endorse one or both shots for them -- and the FDA agrees -- there’s still another hurdle. The Centers for Disease Control and Prevention must recommend whether all tots need immunization or just those at high risk from the virus. (AP Photo/Ron Harris, Manuel Balce Ceneta, File)

This combination of 2022 and 2020 file photos shows logos for the U.S. Centers for Disease Control and Prevention and the Food and Drug Administration. On Wednesday, June 15, 2022, both Moderna and Pfizer will have to convince what’s essentially a science court -- advisers to the Food and Drug Administration -- that their shots work well in babies, toddlers and pre-schoolers. If the FDA’s advisers endorse one or both shots for them -- and the FDA agrees -- there’s still another hurdle. The Centers for Disease Control and Prevention must recommend whether all tots need immunization or just those at high risk from the virus. (AP Photo/Ron Harris, Manuel Balce Ceneta, File)

By LAU­RAN NEER­GAARD | AS­SO­CI­AT­ED PRESS

 

(AP) — Par­ents anx­ious to fi­nal­ly vac­ci­nate their youngest chil­dren against COVID-19, strap in: A lot is set to hap­pen over the next week.

On Wednes­day, both Mod­er­na and Pfiz­er will have to con­vince what’s es­sen­tial­ly a sci­ence court — ad­vis­ers to the Food and Drug Ad­min­is­tra­tion — that their shots work well in ba­bies, tod­dlers and pre-school­ers.

Kids un­der 5 are the on­ly group not yet el­i­gi­ble for COVID-19 vac­ci­na­tion in the U.S. If the agency’s ad­vis­ers en­dorse one or both shots for them -- and the FDA agrees -- there’s still an­oth­er hur­dle. The Cen­ters for Dis­ease Con­trol and Pre­ven­tion must rec­om­mend whether all tots need im­mu­niza­tion or just those at high risk from the virus.

Adding to the com­plex­i­ty, each com­pa­ny is of­fer­ing dif­fer­ent dose sizes and num­ber of shots. And the week won’t even start with the lit­tlest kid de­bate: Mod­er­na first will ask FDA’s ad­vis­ers to sup­port its vac­cine for old­er chil­dren.

On­ly a hand­ful of coun­tries, in­clud­ing Chi­na and Cu­ba, have of­fered dif­fer­ent types of COVID-19 vac­ci­na­tions to chil­dren younger than 5.

 

Here’s a primer to help keep all the de­vel­op­ments straight.

 

PFIZ­ER’S PLAN FOR THE LIT­TLEST

 

Pfiz­er has a pe­di­atric track record -- its COVID-19 vac­cine is the on­ly type the FDA al­lows for chil­dren of any age. Two dos­es plus a boost­er are cleared for every­one 5 and old­er. Shots for the 5- to 11-year-olds con­tain a third of the dose giv­en to teens and adults.

For kids younger than 5, Pfiz­er and its part­ner BioN­Tech low­ered the dose even more, to a tenth of the adult dose. The trade-off is a need for three shots, the first two giv­en three weeks apart and the last at least two months lat­er.

 

MOD­ER­NA’S PLAN FOR THE LIT­TLEST

 

Mod­er­na is seek­ing FDA clear­ance for two shots, each a quar­ter of its adult dose, giv­en about four weeks apart for kids younger than 6. (Mod­er­na test­ed slight­ly dif­fer­ent age groups than Pfiz­er.)

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.

 

MAK­ING THEIR CASE

 

Pfiz­er dis­ap­point­ed par­ents back in De­cem­ber when a study found two shots weren’t quite strong enough. So re­searchers test­ed a third shot in young­sters age 6 months through 4 years dur­ing the win­ter surge of the omi­cron vari­ant.

Pfiz­er’s pre­lim­i­nary da­ta showed af­ter three shots, chil­dren de­vel­oped high lev­els of virus-fight­ing an­ti­bod­ies with no safe­ty prob­lems. In ad­di­tion, the vac­cine ap­peared 80% ef­fec­tive in pre­vent­ing symp­to­matic COVID-19. But that cal­cu­la­tion was based on just 10 cas­es di­ag­nosed among study par­tic­i­pants by the end of April, and it could change if more cas­es have oc­curred since.

Mod­er­na’s study found tots ages 6 months through 5 years de­vel­oped high an­ti­body lev­els af­ter two of its shots. But while there were no se­vere cas­es of COVID-19 dur­ing the tri­al, the vac­cine was on­ly about 40% to 50% ef­fec­tive at pre­vent­ing milder in­fec­tions. Mod­er­na has be­gun test­ing a boost­er for tots.

 

WHEN COULD SHOTS START?

 

If the FDA au­tho­rizes one or both shots — a de­ci­sion ex­pect­ed short­ly af­ter its ad­vi­so­ry pan­el’s meet­ing — all eyes move to the CDC. That agency rec­om­mends how to use vac­cines. Which tots should get COVID-19 vac­ci­na­tion will be an im­por­tant de­bate as the coro­n­avirus doesn’t tend to make chil­dren as sick as adults yet near­ly 500 deaths in U.S. chil­dren un­der 5 have been re­port­ed.

The CDC’s own vac­cine ad­vis­ers are sched­uled to meet next Fri­day and Sat­ur­day, and a fi­nal de­ci­sion by the CDC’s di­rec­tor, Dr. Rochelle Walen­sky, is ex­pect­ed short­ly af­ter they’re done.

If all those steps fall in­to place, vac­ci­na­tions are ex­pect­ed to be­gin in most ar­eas June 21.

 

VAC­CI­NA­TION SITES

 

Pe­di­a­tri­cians, oth­er pri­ma­ry care physi­cians and chil­dren’s hos­pi­tals are ex­pect­ed to vac­ci­nate most of the youngest kids. Lim­it­ed drug­stores are ex­pect­ed to of­fer them for the lit­tlest kids — par­ents should check lo­cal avail­abil­i­ty. The Biden ad­min­is­tra­tion says it al­so is work­ing with a va­ri­ety of oth­er groups, such as chil­dren’s mu­se­ums, to of­fer pop-up clin­ics and reach even more young­sters.

 

WHAT IF MY CHILD RE­CENT­LY HAD COVID-19?

 

About three-quar­ters of chil­dren of all ages are es­ti­mat­ed to have been in­fect­ed at some point dur­ing the pan­dem­ic. It’s a ques­tion sure to come up as CDC’s ad­vis­ers make rec­om­men­da­tions for the lit­tlest kids, so stay tuned.

For old­er ages, the CDC has rec­om­mend­ed vac­ci­na­tion any­way to low­er the chances of re­in­fec­tion. There’s no firm guid­ance on how long to wait; the CDC has said peo­ple may wait three months af­ter an in­fec­tion.

 

DE­MAND IS UN­CLEAR

 

There are rough­ly 18 mil­lion chil­dren younger than 5, and many par­ents are ea­ger to get their tots vac­ci­nat­ed. But it’s un­clear how many ul­ti­mate­ly will, giv­en dis­ap­point­ing vac­cine up­take by old­er chil­dren.

Ac­cord­ing to the CDC, just 29% of kids ages 5 to 11 have got­ten two dos­es, and about 60% of 12- to 17-year-olds.

 

WHAT ABOUT MOD­ER­NA AND OLD­ER KIDS?

 

On Tues­day, the FDA’s ad­vis­ers will con­sid­er whether to clear Mod­er­na shots for old­er kids, those 6 to 17 -- a de­ci­sion that might al­le­vi­ate some par­ent con­fu­sion.

The agency has held up the teen vac­cine for months while it in­ves­ti­gat­ed a rare side ef­fect, heart in­flam­ma­tion. That’s most­ly a risk for teen boys and young men, and al­so can oc­cur with the Pfiz­er vac­cine.

___

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-19HealthUnited StateschildrenPfizerUnited States of AmericaFDAModernaCovid vaccinesCDC


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