Vac­cine trial ex­pands to mi­nors

Ex­pan­sion ex­cites some, is wor­ri­some for oth­ers

USA TODAY US Edition - - NA­TION’S HEALTH - Karen Wein­traub

After school Thurs­day, 12-year-old Ab­hi­nav pushed up his T-shirt sleeve and looked down as a nee­dle pierced his left shoul­der.

The Ohio boy is one of the first chil­dren al­lowed to re­ceive a vac­cine de­signed to pro­tect against COVID-19. His fa­ther, Sharat, also joined the trial.

After months of test­ing its COVID-19 can­di­date vac­cine in adults, Pfizer re­cently low­ered the age of par­tic­i­pa­tion to 16, aim­ing to in­clude at least 3,000 older teens. On Thurs­day, Cincin­nati Chil­dren’s Hospi­tal in­au­gu­rated an even younger group, vac­ci­nat­ing its first two mid­dle school­ers.

Pfizer is the only one of the lead­ing drug com­pa­nies to al­low mi­nors into a vac­cine trial.

Some pe­di­atric vac­cine ex­perts say drug­mak­ers and fed­eral reg­u­la­tors should wait un­til the vac­cines have been proven safe and ef­fec­tive in adults be­fore moving to chil­dren.

“If I were part of the FDA, I would cer­tainly want to be very con­vinced about the safety of a vac­cine be­fore I ap­proved its use in chil­dren,” Dr. Cody Meissner a pe­di­atric in­fec­tious dis­ease ex­pert at Tufts Chil­dren’s Hospi­tal said Thurs­day at a pub­lic meet­ing of an ad­vi­sory panel to the U.S. Food and Drug Ad­min­is­tra­tion. “The pat­tern of dis­ease is very dif­fer­ent in chil­dren, and lump­ing them in with adults would cause me some dis­com­fort.”

But Dr. Bar­bara Pahud, direc­tor of re­search in the in­fec­tious dis­eases depart­ment at Chil­dren’s Mercy Hospi­tal in Kansas City, Mis­souri, said it’s im­moral not to get kids into tri­als as soon as pos­si­ble.

“We should not al­low chil­dren to die,” she said. “That’s our job as pe­di­a­tri­cians to make noise and make sure peo­ple are notic­ing.”

COVID-19 con­ta­gion

Although most chil­dren re­cover well from COVID-19, they can pass the virus to their par­ents, teach­ers and grand­par­ents, so it’s im­por­tant to get them vac­ci­nated, said Dr. Robert Frenck Jr., direc­tor of the Vac­cine Re­search Cen­ter at Cincin­nati Chil­dren’s Hospi­tal Med­i­cal Cen­ter.

Last week, Frenck dosed his first mi­nor with the Pfizer vac­cine, and Thurs­day marked the first younger vol­un­teer.

At least 500,000 Amer­i­can chil­dren have con­tracted COVID-19 this year, Frenck said, and prob­a­bly a lot more. “We’re not nec­es­sar­ily iden­ti­fy­ing all the times when the younger ones are trans­mit­ting to par­ents and grand­par­ents,” he said.

Fewer than 1% of those chil­dren ended up hos­pi­tal­ized, Meissner said, so any vac­cine given to chil­dren has to meet a high bar for safety to out­weigh any risks.

“I worry that the vac­cines ... in ge­net­i­cally pre­dis­posed chil­dren may elicit a very trou­ble­some re­ac­tion,” said Meissner, a mem­ber of the FDA ad­vi­sory panel that met for eight hours Thurs­day to dis­cuss COVID-19 vac­cine de­vel­op­ment.

But Pahud noted more than 100 chil­dren – many who were pre­vi­ously healthy – have died from COVID-19. That’s nearly as many as died in the last year from the flu, which saw a par­tic­u­larly deadly year. Oth­ers have de­vel­oped a dan­ger­ous im­mune over­re­ac­tion.

Pahud said COVID-19 is as dan­ger­ous for chil­dren as other ill­nesses they are vac­ci­nated against, not count­ing the risk in­fec­tious chil­dren present to adults. After the pneu­mo­coc­cal vac­cine was in­tro­duced in chil­dren, for ex­am­ple, doc­tors were pleas­antly sur­prised to see rates of pneu­mo­nia fall.

With COVID-19, she said, “we might have more im­pact in herd im­mu­nity and trans­mis­sion than we know.”

An­other rea­son to test chil­dren, Pahud said: Once a vac­cine is ap­proved for adults, some par­ents will have their chil­dren get it, even with­out fed­eral ap­proval. Ab­sent a trial in chil­dren, there’s no way to know if that will be safe, she said, adding that she wishes such stud­ies had started long ago. “We’re se­verely be­hind,” she said.

Vac­cine test­ing will take longer in kids

Vac­ci­na­tion has fo­cused on adults so far, in part be­cause they are more likely to suf­fer ill ef­fects from the virus, but also be­cause that’s how vac­cines are usu­ally rolled out. Even vac­cines aimed at ba­bies are tested first in adults to make sure they’re safe, Frenck said.

While ado­les­cents are gen­er­ally given an adult dose of a vac­cine, Frenck said younger chil­dren may need a lower dose, which needs to be worked out dur­ing clin­i­cal tri­als.

Pfizer hasn’t re­leased any de­tails of its roll out other than to say it plans to as­sess suc­cess with one age group be­fore moving down to the next.

Frenck said he’s seen very few side ef­fects so far from the vac­cine de­vel­oped by Pfizer and Ger­man com­pany

BioN­Tech. Most re­cip­i­ents are con­vinced they got the placebo, as half the trial par­tic­i­pants will, be­cause they have so few side ef­fects, he said.

Some peo­ple ex­pe­ri­enced fa­tigue, mus­cle or joint aches or a fever for a day or two, but noth­ing se­ri­ous enough to stop par­tic­i­pants from go­ing to work. “Based on all that safety data, I’m not con­cerned about moving into ado­les­cents,” Frenck said. “I think their im­mune sys­tem and their size is ba­si­cally go­ing to see the same re­sults.”

It’s ur­gent to start clin­i­cal tri­als in chil­dren, he added. “With some­thing that has turned our world up­side down, it gives you even a stronger rea­son of why you want to test now,” he said.

Pfizer has not re­leased a time frame for the study of ado­les­cents, but Pahud said test­ing in teens and kids will take longer than in adults, be­cause of par­ents’ hes­i­tancy to ex­pose their chil­dren to un­proven vac­cines.

Chil­dren who are Black or Latino, like their par­ents, are more likely to suf­fer the worst ef­fects of COVID-19, Pahud said, so they should be pri­or­i­tized in any vac­ci­na­tion ef­fort. “It’s a pop­u­la­tion we need to pay at­ten­tion to,” she said.

Per­sonal per­spec­tive

Kate­lyn Evans, 16, de­cided to vol­un­teer for the vac­cine trial be­cause she wanted to be part of the so­lu­tion. “The more peo­ple they have and the more data they have, the sooner they can help peo­ple,” she said.

Last week, when she got her shot, Kate­lyn closed her eyes as the nee­dle went in, but said it didn’t re­ally hurt, and she hasn’t had any side ef­fects since.

Dur­ing the pan­demic, Kate­lyn, a high school ju­nior, has been able to con­tinue with her course­work, though her school switches every week or so from every­one in per­son to half the stu­dents coming two days a week and half the other two.

But COVID-19 has robbed the ac­tive teen from drama club, mock trial, math club, choir – where she proudly sings alto – and run­ning cross coun­try.

The sooner there’s a vac­cine, the sooner life can get back to nor­mal, Kate­lyn said, adding that she’s hop­ing to con­vince her cousin and some friends her age to join in the trial. “They need hun­dreds more peo­ple to get the data they need.”

Pahud said her own 12-year-old daugh­ter asked sev­eral months ago why she couldn’t get vac­ci­nated. “That’s not fair,” she said when Pahud told her chil­dren weren’t yet in­cluded in tri­als.

Pahud said she’s also hear­ing a lot of fear from par­ents wor­ried their child will have one of the rare, bad cases of COVID-19. If noth­ing else, Pahud said, a vac­cine should be able to stem some of that fear.

And if teach­ers are no longer afraid of be­ing in­fected by their stu­dents, they should be more will­ing to re­open schools, which will help all kids and fam­i­lies, re­gard­less of their COVID-19 sta­tus.

“We’re never go­ing to get back to nor­mal with­out hav­ing a vac­cine avail­able for chil­dren,” she said.

CINCIN­NATI CHIL­DREN’S HOS­PI­TAL

Kate­lyn Evans, 16, gets the first of two shots as part of a trial test­ing Pfizer’s COVID-19 vac­cine in mi­nors.

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