The Washington Post - USA (2021-10-27)

WEDNESDAY, OCTOBER 27 , 2021 .THE WASHINGTON POST EZ RE A

Politics &the Nation

BYLAURIEMCGINLEY

ANDKATIESHEPHERD

More than 10 monthsafter
U.S. adultsstarted receivingcor-
onavirusvaccines, the nation’s
youngerchildren moved signifi-
cantly closer togettingashot of
protection whenadvisers to the
Food and DrugAdministration
onTuesdayendorsed the Pfizer-
BioNTech vaccine.
Theadvisorycommittee found
thatthebenefits of the shot out-
weighed the risks ofarare cardiac
sideeffectand voted17 to 0with
oneabstention to back thevac-
cine for children5to11years old,
agroupthatnumbers 28 million.
While the advice is not binding,
the agencyisall but certain to
grant emergencyauthorization
for thevaccine, perhaps as soon
as this week.
Apediatricvaccine has been
eagerly anticipated by manypar-
ents who want to ensure their
children’s safety atschool and
holidaygatherings. Expertssay
the immunizations will represent
amilestone inapandemic that
has killed more than 737,000 peo-
ple in theUnited States.
“Tome, it seems thatitisahard
decision butaclear one,”said
Patrick S.Moore,aUniversity of
Pittsburgh microbiologistand
committee member.Henoted
that 94 childrenbetween5and 11
have died of covid-19, and “all
have names. All of them had
mothers.”
TheCenters for Disease Con-
trol andPrevention’s outside im-
munization advisers are sched-
uled to meetNov.2to recommend
how to use thevaccine. Once CDC
Director RochelleWalenskysigns
off, providers would be able to
give thetwo-dose regimen as soon
as thefirstweek ofNovember.
Theauthorization of thefirst
pediatricvaccine would open the
latestchapter in anextendedef-
forttoimmunize the population
of theUnited States againstthe
coronavirus—anendeavor that
began lastDecember with the
distribution of the Pfizer-
BioNTech vaccine for certain
adults.
Pfizer and itsGerman partner
BioNTech areexpected to have
initial data for children2to
years old and for those6months
to2years old late this year or
early next year.
Thevotecame afteravigorous
debate over the safety of thevac-
cine, which has been linked to
rare heart-related complications,
such asmyocarditis, an inflam-
mation of the heartmuscle. Some
members of the committee ques-
tioned whether the shot should
be used for all children, or just
thoseathigher risk because of
underlying medical conditions.
Several expressed discomfort

about making the decision with-

out more information, while oth-

ers said the data on safety and

efficacywerestrong enough to

move ahead.

“So,Iguess for me it’s always

nerve-racking,Ithink, when

you’reasked to makeadecision

for millions of children based on

studies of onlyafewthousand

children,”saidPaulA.Offit, a

vaccineexpertatChildren’s Hos-

pital of Philadelphia. “I think I

know enough to move forward

with the yes vote, but, you know,

it’s always never when you know

everything,it’swhen do you know

enough?”

Amanda Cohn,avaccineex-

pertatthe CDC and member of

the panel, argued the data clearly

showed thevaccine “will prevent

deaths, will prevent ICU admis-

sions and will prevent significant

long-term adverse outcomes in

children.”

ButMichael G.Kurilla, an in-

fectious-diseases expertatthe

NationalInstitutes ofHealth who

abstained from voting,was more

skeptical.

“There are high-risk individu-

als, andIthinktheydoneed to be

attended to.Wedo need to pro-

videavaccinefor them,”Kurilla

said. “But for manyothers, one

dose or no dose,even. If they’ve

had prior covid infection, they

maynot need anything more.”

Other panel members also said

theywould have preferred to

make more specific recommenda-

tions to emphasize thathigh-risk

children with underlying condi-

tions or suppressed immune sys-

tems shouldgetthevaccine, but

healthychildren mayhold off.

James E.K.Hildreth Sr., chief

executive of MeharryMedical

College,saidhehoped the CDC’s

vaccine advisers, in their meeting

next week, would “prioritize the

vaccine in some way” forchildren

who face the mostrisk from the

virus.Hesaid he voted to recom-

mend the shot primarily because

he wanted“tomakesure thatthe

children who really need thisvac-

cine, primarily the Black and

Brown children in our country,

getthe vaccine.”

ArnoldMonto,aUniversity of

Michigan epidemiologistwho is

acting chairman of the panel,

reminded other committee mem-

bers thattheir vote was justthe

firststep toward making thevac-

cineavailable.TheCDC maybe

able to craftmore clear guidelines

for parents of children5to

years old, he added.

CodyMeissner,apediatrician

at TuftsMedical Center,said he

was worriedabroad authoriza-

tion of thevaccine would lead to

vaccine mandatesat schools.He

said he opposes them until more

safety data isavailable.

ThePfizer-BioNTech andMod-

ernavaccines have been associat-

ed withmyocarditis and peri-

carditis, which is an inflamma-

tion of the heartlining,after the

second dose, particularly in ado-

lescent boys and young men.The

problem did not turn up in the

Pfizer-BioNTech pediatric clini-

cal trial, whichexperts saywas

too small to detectsucharare

complication.

Much of the debate focused on

the FDA’suse ofstatistical model-

ing to trytoanswer thekeyques-

tion for an emergencyauthoriza-

tion: Do thevaccine’s benefits

outweigh the risks?

HongYang,senior adviserat

the FDA’sbiostatistics office, told

the committee the agencyesti-

mated how manyhospitaliza-

tionscaused by covid might be

prevented by thevaccine com-

pared with how manyhospital-

izations might occur because of

vaccine-related heartcomplica-

tions.

Theagencyconcluded the ben-

efits outweighed the risks in al-

mostall scenarios,except possi-

bly when there are verylow levels

of viral transmission.Even then,

the FDAsaid, the benefits might

exceed the risks becausevaccine-

related myocarditis cases have

tended to be mild, while covid can

lead to serious illness and death.

Some panel members suggest-

ed, however,thatthe FDAas-

sumed there would be more covid

cases than will actually occur,

considering the number of cases

is declining.Such an overesti-

mate would inflate the benefits of

thevaccine.

ButMonto cautioned thatsci-

entists have assumed in the past

thatthepandemic was waning

and“been caught flat-footed as

therates again went up. So...

thinking thatthisisgoing to be

the end of the wave permanently

is maybealittle overly optimis-

tic.”

William C. Gruber,senior vice

president forvaccine clinical re-

search and developmentat Pfizer,

told the panel thevaccine could

have salutaryeffects beyond pre-

venting illness, including allow-

ing more in-person school and

reducing the transmission of the

virus—anargument thatreso-

nated with several panel mem-

bers.

There were 2,268 children orig-

inally in the Pfizer-BioNTech tri-

al,two-thirds of whom received

thevaccine with the restreceiving

aplacebo. After regulators asked

the companytoincrease the trial

size, partly to broaden its safety

database, the trial wasexpanded

to about 4,500 children.

Thecompanies reported that

the trial showed thevaccine is

almost91percenteffective in pre-

venting symptomatic coronavi-

rus, with 16 cases of covid in the

placebo group and three in the

vaccine group.Theregimen for5-

to 11-year-olds is 10 micrograms,

one-third the dose for people 12

andolder.Aswith the older

group, children would receive the

vaccine intwodoses three weeks

apart.

ThroughoutTuesday, health of-

ficialsstressed thatwhile chil-

dren are much less likely to be-

come seriously ill from the virus,

theyare far from unscathed.

PeterMarks, director of the

FDA’sCenter for BiologicsEvalua-

tion and Research, said 1.9mil-

lion children5to11years old have

been infected by the coronavirus

and more than 8,300 have been

hospitalized.

During the partofthe meeting

devoted to public comment, sev-

eral people argued thatthevac-

cine was not safe, thatauthoriz-

ing it would lead to mandates and

urged the advisers to rejectit.

Others pressed for thevaccine to

be cleared.

“Wehaven’t taken our daugh-

ter to eatinsideof arestaurant or

to the movies or onaplane since

covid began,”saidBelinda

Macauley, anattorneyinThou-

sand Oaks, Calif., who has an

8-year-old daughter.“Myfamily is

enthusiastically in favor of

prompt approval and our daugh-

ter willgetitthefirstdayit’s

authorized.”

Nevertheless, some experts

predictthere won’tbeahuge

floodofvaccinations anytime

soon. Aaron E. Carroll,apediatri-

cian and chiefhealth officer of

Indiana University, said people

are overestimating “how many

parents will rush out andgettheir

childrenvaccinated.Manypar-

ents will be conservative, they

will want to wait.”

While alargeproportion of

older people arevaccinated, par-

ents of small children tend to be

young,withmuch lower immuni-

zationrates, Carroll noted, add-

ing theyare unlikely togettheir

children immunized if theyhave

not beenvaccinated themselves.

Only about half of adolescents

eligible for avaccinehavere-

ceived it, with the numbers high-

er among the older adolescents,

he said.

Carroll’s concern is backed up

byaKaiserFamilyFoundation

reportissued lastmonth.It found

thatonlyabout one-third of par-

ents who have children5to

years old saytheywouldvacci-

nate their children as soon as

possible. Another third said they

would “wait and see,”while

24 percent said theywould“defi-

nitely not”get their childrenvac-

cinated. Seven percent saythey

would do so only if required.

Booster shots of theModerna

andJohnson&Johnsonvaccines

becameavailable for some people

lastweek after federal regulators

gave their blessing to the addi-

tional doses and declared that

people who are eligible for an

additional shot could getany

booster regardless of whichvac-

cine theyoriginally received.

Asthe authorization of the pe-

diatric vaccine approaches, the

Biden administration and Pfizer-

BioNTech have been racing to

prepare to distribute thevaccine

and reduce the potential for con-

fusion among medical providers

administering pediatric and

adult doses.

NicholasW.Warne, Pfizer’s

vicepresident of pharmaceutical

research and development, told

the FDAadvisers the company

willpackagethe pediatricvac-

cinewithorangevialcaps, or-

angelabels, orangeboxes and

orangeshippingcartons to differ-

entiate it from shots givento

adultsand adolescents. Thehigh-

er-dosevaccine for individuals 12

and older comes inavialwith a

purplecap.

WhiteHouse officials have said

theyhavebought enough doses to

vaccinateeverychild in the5to

agegroup.Theyplan to makethe

specially packagedvaccineavail-

ableat more than 25,000 pediatri-

cians and doctors offices, hospi-

tals, pharmacies, community

health centers, and school- and

community-based clinics. They

also will conductacampaign to

educate parents more fully about

thevaccines.

[email protected]

[email protected]

FDA advisers back Pfizer vaccine for children 5to

0

50k

100k

150k

200k

250k

300k

7-dayavg.

Feb. 29, 2020 Jan. 2021 Oct.

0

2k

4k

7-dayavg.

Feb. 29, 2020 Jan. 2021 Oct.

0

1m

2m

3m

4m

7-dayavg.

Feb. 29, 2020 Jan. 2021 Oct.

As of8p.m. Tuesday

45,444,

95,

415,012,

709,

737,

Yesterday 2,

Total

DEATHS

Yesterday

Total

VACCINE DOSES ADMINISTERED

Newcoronavirus cases, deaths and

vaccine doses in theU.S., by day

Total

CASES

Yesterday

Committee finds benefits

of the shot outweigh

risks of side effects

JONATHAN ERNST/REUTERS

Aprekindergartenstudent wearsamaskat EastEndElementarySchoolin NorthPlainfield,N.J. The

Food and Drug Administration is settogrant emergencyauthorizationto the Pfizer-BioNTechvaccine

for children5to11assoon as thisweek.More than28 million American children wouldbeeligible.

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