A tech­ni­cal­i­ty could keep RSV shots from kids in need

Af­ter more than five decades of try­ing, the drug in­dus­try is on the verge of pro­vid­ing ef­fec­tive im­mu­niza­tions against the res­pi­ra­to­ry syn­cy­tial virus, which has put an es­ti­mat­ed 90,000 US in­fants and small chil­dren in the hos­pi­tal since the start of Oc­to­ber.

But on­ly one of the shots is de­signed to be giv­en to ba­bies, and a glitch in con­gres­sion­al lan­guage may make it dif­fi­cult to al­low chil­dren from low-in­come fam­i­lies to get it as read­i­ly as the well-in­sured.

Since 1994, rou­tine vac­ci­na­tion has been a child­hood en­ti­tle­ment un­der the Vac­cines for Chil­dren pro­gram, through which the fed­er­al gov­ern­ment buys mil­lions of vac­cines and pro­vides them free through pe­di­a­tri­cians and clin­ics to chil­dren who are unin­sured, un­der­in­sured, or on Med­ic­aid — more than half of all Amer­i­can kids.

Kel­ly Moore

The 1993 law cre­at­ing the pro­gram didn’t specif­i­cal­ly in­clude an­ti­body shots, which were used on­ly as rare emer­gency ther­a­py at the time the bill was writ­ten.

But the first med­ica­tion of its kind like­ly to be avail­able to ba­bies, called nir­se­vimab (it was ap­proved in Eu­rope in De­cem­ber, and FDA ap­proval is ex­pect­ed this sum­mer), is not a vac­cine but rather a mon­o­clon­al an­ti­body that neu­tral­izes RSV in the blood­stream.

The Cen­ters for Dis­ease Con­trol and Pre­ven­tion’s Ad­vi­so­ry Com­mit­tee on Im­mu­niza­tion Prac­tices is cer­tain to rec­om­mend giv­ing the an­ti­body to in­fants, said Kel­ly Moore, pres­i­dent of the ad­vo­ca­cy group Im­mu­nize.org. The CDC is cur­rent­ly as­sess­ing whether nir­se­vimab would be el­i­gi­ble for the Vac­cines for Chil­dren pro­gram, agency spokesper­son Kris­ten Nord­lund told KHN.

Fail­ing to do so would “con­sign thou­sands up­on thou­sands of in­fants to hos­pi­tal­iza­tion and se­ri­ous ill­ness for se­man­tic rea­sons de­spite ex­is­tence of an im­mu­niza­tion that func­tion­al­ly per­forms just like a sea­son­al vac­cine,” Moore said.

Bar­ney Gra­ham

Of­fi­cials from Sanofi, which is pro­duc­ing the nir­se­vimab in­jec­tion along with As­traZeneca, de­clined to state a price but said the range would be sim­i­lar to that of a pe­di­atric vac­cine course. The CDC pays about $650 for the most ex­pen­sive rou­tine vac­cine, the four shots against pneu­mo­coc­cal in­fec­tion. In oth­er words, FDA ap­proval would make nir­se­vimab a block­buster drug worth bil­lions an­nu­al­ly if it’s giv­en to a large share of the 3.7 mil­lion or so chil­dren born in the US each year.

Pfiz­er and GSK are mak­ing tra­di­tion­al vac­cines against RSV and ex­pect FDA ap­proval lat­er this year. Pfiz­er’s shot ini­tial­ly would be giv­en to preg­nant women — to shield their ba­bies from the dis­ease — while GSK’s would be giv­en to the el­der­ly.

Jon Hein­richs

Vac­cines de­signed for in­fants are in the pipeline, but some ex­perts are still ner­vous about them. A 1966 RSV vac­cine tri­al failed spec­tac­u­lar­ly, killing two tod­dlers, and im­mu­nol­o­gists aren’t to­tal­ly in agree­ment over the cause, said Bar­ney Gra­ham, the re­tired Na­tion­al In­sti­tutes of Health sci­en­tist whose stud­ies of the episode con­tributed to suc­cess­ful Covid-19 and RSV vac­cines.

Af­ter two years of Covid lock­downs and mask­ing slowed its trans­mis­sion, RSV ex­plod­ed across the Unit­ed States this year, swamp­ing pe­di­atric in­ten­sive care units.

Sanofi and As­traZeneca hope to have nir­se­vimab ap­proved by the FDA, rec­om­mend­ed by the CDC, and de­ployed na­tion­wide by fall to pre­vent fu­ture RSV epi­demics.

Sean O’Leary

Their prod­uct is de­signed to be pro­vid­ed be­fore a ba­by’s first win­ter RSV sea­son. In clin­i­cal tri­als, the an­ti­bod­ies pro­vid­ed up to five months of pro­tec­tion. Most chil­dren wouldn’t need a sec­ond dose be­cause the virus is not a mor­tal dan­ger to healthy kids over a year old, said Jon Hein­richs, a se­nior mem­ber of Sanofi’s vac­cines di­vi­sion.

If the an­ti­body treat­ment is not ac­cept­ed for the Vac­cines for Chil­dren pro­gram, that will lim­it ac­cess to the shot for the unin­sured and those on Med­ic­aid, the ma­jor­i­ty of whom rep­re­sent racial or eth­nic mi­nori­ties, Moore said. The drug­mak­ers would have to ne­go­ti­ate with each state’s Med­ic­aid pro­gram to get it on their for­mu­la­ries.

Ex­clud­ing the shot from Vac­cines for Chil­dren “would on­ly wors­en ex­ist­ing health dis­par­i­ties,” said Sean O’Leary, a pro­fes­sor of pe­di­atrics at the Uni­ver­si­ty of Col­orado and chair of the in­fec­tious dis­eases com­mit­tee of the Amer­i­can Acad­e­my of Pe­di­atrics.

Leonard Fried­land

RSV af­fects ba­bies of all so­cial class­es but tends to hit poor, crowd­ed house­holds hard­est, said Gra­ham. “Fam­i­ly his­to­ry of asth­ma or al­ler­gy makes it worse,” he said, and pre­ma­ture ba­bies are al­so at high­er risk.

While 2% to 3% of US in­fants are hos­pi­tal­ized with RSV each year, on­ly a few hun­dred don’t sur­vive. But as many as 10,000 peo­ple 65 and old­er per­ish be­cause of an in­fec­tion every year, and a lit­tle-dis­cussed le­gal change will make RSV and oth­er vac­cines more avail­able to this group.

A sec­tion of the 2022 In­fla­tion Re­duc­tion Act that went in­to ef­fect Jan. 1 ends out-of-pock­et pay­ments for all vac­cines by Medicare pa­tients — in­clud­ing RSV vac­cines, if they are li­censed for this group.

Jen­nifer Re­ich

Be­fore, “if you hadn’t met your de­ductible, it could be very ex­pen­sive,” said Leonard Fried­land, VP for sci­en­tif­ic af­fairs and pub­lic health in GSK’s vac­cines di­vi­sion, which al­so makes shin­gles and com­bi­na­tion tetanus-diph­the­ria-whoop­ing cough boost­ers cov­ered by the new law. “It’s a tremen­dous­ly im­por­tant ad­vance.”

Of course, high lev­els of vac­cine hes­i­tan­cy are like­ly to blunt up­take of the shots re­gard­less of who pays, said Jen­nifer Re­ich, a Uni­ver­si­ty of Col­orado so­ci­ol­o­gist who stud­ies vac­ci­na­tion at­ti­tudes.

Hei­di Lar­son

New types of shots, like the Sanofi-As­traZeneca an­ti­bod­ies, of­ten alarm par­ents, and Pfiz­er’s shot for preg­nant women is like­ly to push fear but­tons as well, she said.

Pub­lic health of­fi­cials “don’t seem very savvy about how to get ahead” of claims that vac­cines un­der­mine fer­til­i­ty or oth­er­wise harm peo­ple, said Re­ich.

On the oth­er hand, this win­ter’s RSV epi­dem­ic will be per­sua­sive to many par­ents, said Hei­di Lar­son, leader of the Vac­cine Con­fi­dence Pro­ject and a pro­fes­sor of an­thro­pol­o­gy at the Lon­don School of Hy­giene and Trop­i­cal Med­i­cine.

Lau­ra Ri­ley

“It’s a scary thing to have your kid hos­pi­tal­ized with RSV,” she said.

While un­for­tu­nate, “the high num­ber of chil­dren who died or were ad­mit­ted to the ICU in the past sea­son with RSV — in some ways that’s help­ful,” said Lau­ra Ri­ley, chair of ob­stet­rics and gy­ne­col­o­gy at Weill Cor­nell Med­i­cine in New York City.

Spe­cial­ists in her field haven’t re­al­ly start­ed talk­ing about how to com­mu­ni­cate with women about the vac­cine, said Ri­ley, who chairs the im­mu­niza­tion group at the Amer­i­can Col­lege of Ob­ste­tri­cians and Gy­ne­col­o­gists.

“Every­one’s been wait­ing to see if it gets ap­proved,” she said. “The ed­u­ca­tion has to start soon, but it’s hard to roll out ed­u­ca­tion be­fore you roll out the shot.”

By Arthur Allen

First pub­lished at KHN (Kaiser Health News) — a non­prof­it news ser­vice cov­er­ing health is­sues. It is an ed­i­to­ri­al­ly in­de­pen­dent pro­gram of KFF (Kaiser Fam­i­ly Foun­da­tion), which is not af­fil­i­at­ed with Kaiser Per­ma­nente.

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