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Monday, March 17, 2025

Moderna seeks to be 1st with COVID shots for littlest kids

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1053 days ago
20220428
FILE - A health worker administers a dose of a Moderna COVID-19 vaccine during a vaccination clinic in Norristown, Pa., Tuesday, Dec. 7, 2021. Moderna on Thursday, April 28, 2022, asked U.S. regulators to authorize low doses of its COVID-19 vaccine for children younger than 6, a long-awaited move toward potentially opening shots for millions of tots by summer. (AP Photo/Matt Rourke, File)

FILE - A health worker administers a dose of a Moderna COVID-19 vaccine during a vaccination clinic in Norristown, Pa., Tuesday, Dec. 7, 2021. Moderna on Thursday, April 28, 2022, asked U.S. regulators to authorize low doses of its COVID-19 vaccine for children younger than 6, a long-awaited move toward potentially opening shots for millions of tots by summer. (AP Photo/Matt Rourke, File)

By LAU­RAN NEER­GAARD

 

(AP) — Mod­er­na on Thurs­day asked U.S. reg­u­la­tors to au­tho­rize low dos­es of its COVID-19 vac­cine for chil­dren younger than 6, a long-await­ed move to­ward po­ten­tial­ly open­ing shots for mil­lions of tots by sum­mer.

Frus­trat­ed fam­i­lies are wait­ing im­pa­tient­ly for a chance to pro­tect the na­tion’s lit­tlest kids as all around them peo­ple shed masks and oth­er pub­lic health pre­cau­tions — even though high­ly con­ta­gious coro­n­avirus mu­tants con­tin­ue to spread.

Mod­er­na sub­mit­ted da­ta to the Food and Drug Ad­min­is­tra­tion that it hopes will prove two low-dose shots can pro­tect ba­bies, tod­dlers and pre-school­ers — al­beit not as ef­fec­tive­ly dur­ing the omi­cron surge as ear­li­er in the pan­dem­ic.

“There is an im­por­tant un­met med­ical need here with these youngest kids,” Dr. Paul Bur­ton, Mod­er­na’s chief med­ical of­fi­cer, told The As­so­ci­at­ed Press. Two kid-size shots “will safe­ly pro­tect them. I think it is like­ly that over time they will need ad­di­tion­al dos­es. But we’re work­ing on that.”

Now, on­ly chil­dren ages 5 or old­er can be vac­ci­nat­ed in the U.S., us­ing ri­val Pfiz­er’s vac­cine, leav­ing 18 mil­lion younger tots un­pro­tect­ed.

Mod­er­na’s vac­cine isn’t the on­ly one in the race. Pfiz­er is soon ex­pect­ed to an­nounce if three of its even small­er-dose shots work for the lit­tlest kids, months af­ter the dis­ap­point­ing dis­cov­ery that two dos­es weren’t quite strong enough.

Whether it’s one com­pa­ny’s shots or both, FDA vac­cine chief Dr. Pe­ter Marks said the agency will “move quick­ly with­out sac­ri­fic­ing our stan­dards” in de­cid­ing if tot-sized dos­es are safe and ef­fec­tive.

While ques­tions are swirling about what’s tak­ing so long, Marks point­ed­ly told law­mak­ers this week that the FDA can’t eval­u­ate a prod­uct un­til a man­u­fac­tur­er com­pletes its ap­pli­ca­tion. FDA will pub­licly de­bate the ev­i­dence with its sci­en­tif­ic ad­vis­ers be­fore mak­ing a de­ci­sion, and Marks said mul­ti­ple meet­ings would be set to cov­er sev­er­al ex­pect­ed ap­pli­ca­tions.

“It’s crit­i­cal­ly im­por­tant that we have the prop­er eval­u­a­tion so that par­ents will have trust in any vac­cines that we au­tho­rize,” Marks told a Sen­ate com­mit­tee.

If FDA clears vac­ci­na­tions for the lit­tlest, next the Cen­ters for Dis­ease Con­trol and Pre­ven­tion would have to rec­om­mend who needs them — all tots or just those at high­er risk from COVID-19.

Many par­ents are des­per­ate for whichev­er vac­cine gets to the sci­en­tif­ic fin­ish line first.

“We’ve been kind of left be­hind as every­body else moves on,” said Mea­gan Dun­phy-Daly, a Duke Uni­ver­si­ty ma­rine bi­ol­o­gist whose 6-year-old daugh­ter is vac­ci­nat­ed — but whose 3-year-old and 18-month-old sons are part of Pfiz­er’s tri­al.

The fam­i­ly con­tin­ues to mask and take oth­er pre­cau­tions un­til it’s clear if the boys got re­al vac­cine or dum­my shots. If it turns out they weren’t pro­tect­ed in the Pfiz­er study and Mod­er­na’s shots are cleared first, Dun­phy-Daly said she’d seek them for her sons.

“I will feel such a sense of re­lief when I know my boys are vac­ci­nat­ed and that the risk of them get­ting a se­ri­ous in­fec­tion is so low,” she said.

Some par­ents even have urged the gov­ern­ment to let fam­i­lies choose shots be­fore all the ev­i­dence is in.

“This strain of COVID feels al­most im­pos­si­ble to dodge,” Dana Walk­er, a moth­er of an 8-month-old, tear­ful­ly told a CDC meet­ing last week. “Cut red tape and al­low par­ents to pro­tect their kids.”

The FDA will face some com­plex ques­tions.

In a study of kids ages 6 months through 5 years, two Mod­er­na shots — each a quar­ter of the reg­u­lar dose — trig­gered high lev­els of virus-fight­ing an­ti­bod­ies, the same amount proven to pro­tect young adults, Bur­ton said. There were no se­ri­ous side ef­fects, and the shots trig­gered few­er fevers than oth­er rou­tine vac­ci­na­tions.

But the vac­cine proved be­tween about 40% and 50% ef­fec­tive at pre­vent­ing symp­to­matic COVID-19 dur­ing the tri­al. Bur­ton blamed the omi­cron vari­ant’s abil­i­ty to par­tial­ly evade vac­cine im­mu­ni­ty, not­ing that un­boost­ed adults showed sim­i­lar­ly less ef­fec­tive­ness against milder omi­cron in­fec­tions. While no chil­dren be­came se­vere­ly ill dur­ing the study, he said high an­ti­body lev­els are a proxy for pro­tec­tion against more se­ri­ous ill­ness — and the com­pa­ny will test a child boost­er dose.

An­oth­er is­sue: So far in the U.S., Mod­er­na’s vac­cine is re­strict­ed to adults. Oth­er coun­tries have ex­pand­ed the shot to kids as young as 6. But months ago, the FDA cit­ed con­cern about a rare side ef­fect, heart in­flam­ma­tion, in teen boys, and it hasn’t ruled on Mod­er­na’s ear­li­er pae­di­atric ap­pli­ca­tions.

Bur­ton said the FDA may con­sid­er its vac­cine for chil­dren of all ages — but al­so might open it first to the youngest kids who have no oth­er op­tion. He said safe­ty da­ta from mil­lions of old­er chil­dren giv­en Mod­er­na vac­ci­na­tions abroad should help re­as­sure par­ents.

While COVID-19 gen­er­al­ly isn’t as dan­ger­ous in young­sters as adults, some do be­come se­vere­ly ill or even die. About 475 chil­dren younger than 5 have died from COVID-19 since the pan­dem­ic’s start, ac­cord­ing to the CDC, and child hos­pi­tal­iza­tions soared at omi­cron’s peak.

Yet it’s not clear how many par­ents in­tend to vac­ci­nate the youngest kids. Less than a third of chil­dren ages 5 to 11 have had two vac­ci­na­tions, and 58% of those ages 12 to 17.

COVID-19HealthUnited StateschildrenCovid-19 outbreakCovid vaccines


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