The Washington Post - USA (2020-12-11)

A2 EZ SU THE WASHINGTON POST.FRIDAY, DECEMBER 11 , 2020

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lAphotocaption withaDec. 9

Styl earticle about OliviaJade —

daughterofactress Lori Loughlin

and fashiondesignerMossimo

Giannulli—breaking her silence

on her family’s role in the 2019

college admissions scandal

transposed thenames of “Red

TableTalk” hostsJada Pinkett

Smith and Adrienne Banfield-

Norris. Thephoto is reprinted

above withacorrected caption.

lAphotocaption withalisting of

newmoviesavailableonline in

today’s Weekend section,which

was printed in advance,

incorrectly says thatthe

documentary“Alabama Snake”

examines the case ofapreacher’s

wife who was accused of trying to

kill her husband.Rather,itwas

the preacherwho was accused of

tryin gtokillhis wife.

lADec. 10Page One article

about the disclosure thatJohns

Hopkins, founder of the

universityand hospital thatbear

his name,enslavedat least four

Black peoplemisstatedthe first

name ofasigner of the

DeclarationofIndependence.He

was CharlesCarroll,not John

Carroll.

lABusiness Digestitem in the

Dec. 10 A-sectionincorrectly said

thatFox Corp. plans to launch an

online videoweatherservice next

year.ItisFox News Media, a

divisionofFox Corp., thatis

planningthe launch.

TheWashingtonPost is committed to

correctingerrorsthatappearinthe

newspaper.Those interested in

contactingthe paperfor that purpose

can:

Email:[email protected].

Call:202-334-6000,andask to be

connected to the desk involved —

National,Foreign, Metro,Style, Sports,

Business or anyoftheweekly sections.

Comments can be directed toThe

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[email protected].

Allprogramswill bestreamed
live atwashingtonpostlive.com,on
FacebookLive,YouTube,and
Twitter.Email
[email protected] to submit
questions for our upcoming
speakers.

Friday, Dec. 11|11:00a.m.ET

RaceinAmerica: ThePower of
Representation

Rep. ShariceDavids(D-KS)

Rep. DebHaaland (D-NM)

Hosted by KarenTumulty

UpcomingWashington

Post Liveevents

REDTABLE TALK/FACEBOOK WATCH

Clockwise from left, “Red Table Talk” hosts Jada Pinkett Smith,

Adrienne Banfield-Norris and Willow Smith with guest Olivia Jade.

verypoor.”

Thepanelalsoengaged in

extensive debateoverhow to

handle the difficult issue of when

to give participants who received

aplacebo access to thevaccine.

Someparticipants have called for

it, but the FDAhas expressed

concernsthat“unblinding” the

continuing trial could hurtef-

forts to collectlonger-term safety

data.

Pfize rofficial sonThursday

proposed to FDAthatpartici-

pants in the placebo group be

allowed to access the vaccine

when theybecome eligibleunder

guidelines for thegeneral public.

Those guidelines are being is-

suedbyfederal,stateand local

governments.

In preparation for the meet-

ing,the FDAonTuesdaypub-

lisheda53-page evaluation say-

ing thevaccine appears to meet

the standards it laid out in recent

months for emergencyauthori-

zation. Theagencyhas said a

vaccine mustbeatleast50per-

centeffective; itsown scientists

confirmedPfizer’sassessment

thatthe vaccine regimen was 95

percenteffectiveat preventing

covid-19inalargeclinica ltrial.

On safety,the FDAfound that

the vaccine has “a favorablesafe-

ty profile, with no specific safety

concerns identified thatwould

prec lude issuanceofan[emer-

gencyauthorization].”The vac-

cinecaused several sideeffects,

including sore arms,fatigue,

headaches, musclepain and

chills,but theytypically disap-

peared afteraday or two. Pfizer

provided the agencywithamedi-

an oftwomonths of follow-up on

38,000 participantsinthe trial.

Theone surprise in the report

was thatthe firstshot in the

two-dose regimen was52 percent

protective againstcovid-19 in the

three weeks between the two

shots. But the FDAnoted that

there wasn’tenoughdatatodraw

firm conclusions about theeffi-

cacyofasingle shot.

Governmentofficials have

said theyplan to hold back

supplies for the second shots,

which mustbegiventhree weeks

later ,toensure sufficient supply

of the shot thatprovidespeople

getcomplete protection. But the

signal of early protection from a

singledose has led someto

suggest thatmay not be the best

waytouse limited dosesamid

surging cases.

During theportion of the

FDA’sadvisory committee meet-

ing for thegeneral public, some

expressed concerns about green

lightingavaccine thatwas so

rapidly developed and reviewed.

Others like Evan Fein expressed

strongsupport.

Fein told the panel he wasa

clinicaltrial participantat New

York University and strongly

urgedquick action.

He said he is certain hegotthe

vaccine lastsummer —not a

placebo —because he had fa-

tigue, fever and muscle aches

after thesecond shot. Buthesaid

therewere no longer-term side

effects.

He said it would be “immoral

and unethical”tonot authorize

the vaccine.

[email protected]

[email protected]

[email protected]

in the trial.

Pregnant women have been

excluded from coronavirusvac-

cinetrials ,but the FDA’slimited

data suggests no specificrisk to

pregnantwomenorafetus.Fink,

said the agencyisexpecting re-

sults later this monthfroma

developmental and reproductive

study in animalsthatcould help

elucidate risks, but said the agen-

cy will probably allow pregnant

women and theirdoctors to de-

cide whether or nottotakethe

vaccine.

An authorizationfor Pfizer-

BioNTech is the firstofwhat

healthexperts hope will be sev-

eral vaccines to cross thefinish

line.Next to be considered is

Moderna’svaccine. TheFDA will

releaseits assessment of that

vaccine onTuesday, and the advi-

sorycommitteewillreviewiton

Dec.17. If it gets favorableevalua-

tions,asexpected,the FDAis

likely to authorize thatvaccine

within days.

Between thetwovaccines,gov-

ernmentofficials projecthaving

40 milliondosesbyyear’send —

enoughtofully vaccinate 20 mil-

lion people with thetwo-shot

regimen.

Despite thecommittee’scon-

sensus that thevaccine is safe

and effective, there wasat least

one cautionarynote about the

absence of long-term data.

A. Oveta Fuller,associate pro-

fessorofmicrobiology andim-

munologyatthe University of

Michigan,votedagainstthe rec-

ommendation,expressing con-

cerns about the lack of long-term

safety data foravaccine technol-

ogynot usedbefore in humans.

She called therisk “limited”

but predicted “the uptake in the

communityisgoingtobe

ish regulators ordered hospitals

to avoid giving the shots to

people withahistoryof “signifi-

cant”allergic reactions.That di-

rectivecame after twohealth-

care workers hadseverereac-

tions after receiving the first

dose of thevaccine, which British

regulatorsauthorized last week.

British authorities said both

workers haveahistor yofserious

allergies.

SusanWollersheim,amedical

officer in the FDA’sOffice of

VaccinesResearch and Review,

said the FDAhas asked Pfizer to

monitor vaccine recipients for

“anaphylacticreactions” asapo-

tentialrisk following the British

report.

Much remainsunknown

about the cases in theUnited

Kingdom, andexperts said more

data was urgently needed. A

specificstudy could be done to

see whether thevaccine carried

risktopeople with severe aller-

gies—data thatmight be essen-

tialtooverc omeconcerns from

Americans who heard alarming

news reports.

“There are tens of millions of

people in this country thatcarry

EpiPens because theyhavepea-

nut allergies and eggallergies,”

Offitsaid.“They are going to

believe thattheycan’t getthis

vaccine.That is alot of people.”

In its review, the FDAfounda

slightly higher number of ad-

verseevents—“potentially rep-

resenting allergic reactions”—in

the groupthatreceived thevac-

cine, compared with those who

gotthe placebo.There were 137

“hypersensitivity-related”reac-

tions to thevaccine, compared

with111 suchevents in thepla-

cebogroup .But therewereno

cases of anaphylactic reactions

disease in thatage group and

how fewhad participated in the

trial.

“I would have voted ‘yes’ most

enthusiastically had the lan-

guagebeen ‘... 18 years of age

and older,’ ”said David Kim,

director of the divisionofVac-

cines in the Office ofInfectious

Diseaseand HIV/AIDS Policyin

the Department ofHealth and

Human Services.

Those arguments were vehe-

mently disputed by panel mem-

ber Paul Offit, apediatrician and

vaccineexpertatthe Children’s

Hospital of Philadelphia.“Kids

in our hospital have had cardiac

anomalies,” he said.“We have

clearevidence of benefitand all

we have on the other side is

theoretical risk.”

If as expected the FDAfollows

quickly withanemergencyau-

thorization, the shotswillstart

being moved to thestates within

24 hours, according to officialsat

Operation Warp Speed,the

Trump administration’s effortto

acceleratethe development and

deliveryofvaccines.Inoculations

could begin earlynext week.

After the FDAauthorization,

an advisorycommittee to the

Centers for DiseaseControl and

Prevention will vote on whether

to recommend thevaccine and

for which groups.Firstinl ine to

be inoculated arehealth-care

personnel and residents andstaff

of long-term-care facilities, ac-

cordingtoits previousrecom-

mendations. Butstates willhave

the finalsay on whogets thefirst

shots and wheretheyare admin-

istered.Thoseconsiderations are

complicated byextreme logistics

challenges, including the sub-

Antarcticstorag etemperatures

the vaccine requires.

Thetwo-shotvaccine, which

has been shown 95 percenteffec-

tive inrandomized trials involv-

ing thousands of people,has

alreadybeen approved by the

UnitedKingdom, Canada, Bah-

rain and Saudi Arabia.U.S.offi-

cials, however,havehewed to a

more rigorous approval process

thattheybelieve will boostconfi-

dence in thevaccine amongthe

general public. Surveys show

manypeopleint he United States

remain unsure about the safety

of thevaccines andwhetherthey

willget the shots.

“The American public de-

mands anddeservesarigorous,

comprehensive and independent

reviewofthe data, ”said Doran

Fink, deputydirector of the FDA’s

DivisionofVaccinesand Related

Products. “ThatiswhatFDA

physicians and scientists, all of

us careerpublic health servants,

have been doing over days,

nights, weekends and, yes, over

the Thanksgivingholiday.”

Asense of urgencyhung over

the hearing. KathrinJansen, Pfi-

zer’s head of vaccine research

and development, told the panel

that“withthe highefficacyand

good safety profile shown for our

vaccine, and the pandemic essen-

tially out of control,vaccinein-

troductionisanurgent need.”

Still, thevaccine is coming too

late to eliminateastaggering loss

of life anticipated this winter,

CDC Director Robert Redfield

said Thursdaytothe Councilon

Foreign Relations.“Weare in the

time framenow that,probably

for the next60 to 90 days, we’re

goingtohavemoredeath sper

daythanwehad at 9/11 [terrorist

attacks]orwehad at Pearl Har-

bor,” he said.

Duringthe meeting,commit-

tee members pressed the FDAon

the vaccine’s safety,raising ques-

tions about adverse reactions

reportedWednesdaywhen Brit-

VACCINEFROMA

Pfizer vaccine earns FDA advisory panel’s approval

DANIEL ACKER/BLOOMBERG NEWS

KathrinJansen, Pfizer’s head ofvaccineresearch anddevelopment,toldthe FDA’sadvisorypanelon

Thursdaythatvaccine introductionis“urgent.”Formore, visit wapo.st/VaccineReality

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