The Wall Street Journal - USA (2020-12-03)

A8| Thursday, December 3, 2020 ***** THE WALL STREET JOURNAL.

U.S. NEWS

the FDA in the U.S. is planning

to review the vaccine on Dec.

10. The FDA could authorize
    soon after, and supplies should
    become available not long after
    that. Robert Redfield, director
    of the federal Centers for Dis-
    ease Control and Prevention,
    approved a recommendation
    on Wednesday made by an ad-
    visory panel to provide initial
    doses of the vaccine in the U.S.
    to health-care workers and
    nursing-home residents.
    Canada said it expects to
    soon complete its review of
    the Pfizer vaccine, possibly by
    mid-December.
    The FDA and the EMA have
    defended their slower ap-
    proach. Both agencies have
    rapidly compressed their own
    typical vaccine-approval time-
    lines, and both are expected to
    make a decision on the Pfizer
    vaccine this month.
    At the FDA’s Dec. 10 public
    meeting, expert advisers will
    discuss emergency-use autho-
    rization of the vaccine. Scien-
    tists and other members of
    the public can submit com-
    ments beforehand. The next
    day, the EMA will host a vir-
    tual public meeting to talk
    about vaccine development

and regulatory reviews.

Such meetings—designed to

bolster confidence in the regu-

latory process—require exten-

sive time and planning. Re-

searchers said they might help

address people’s hesitancy to

take vaccines.

The FDA is expected to make

a decision on the Pfizer shot a

few days after the Dec. 10 meet-

ing. The FDA scheduled the

public meeting in November, in

part to assure the public it

wasn’t being rushed by political

considerations. It is expected to

rule on a vaccine fromMod-

ernaInc. shortly after it makes

a call on the Pfizer shot.

FDA Commissioner Stephen

Hahn told ABC News on Tues-

day that the agency would take

the time necessary to perform

its own analysis. Mr. Hahn was

ordered to provide a timeline

for approval of a Covid-19 vac-

cine in a meeting on Tuesday

with President Trump’s chief of

staff, Mark Meadows, people

familiar with the events said.

The U.K. has ordered 40

million doses, enough to vacci-

nate 20 million people. Health

Secretary Matt Hancock said

on Wednesday the country is

expecting an initial 800,

doses to arrive in Britain next

week. He said the speed at

which vaccinations will take

place will depend on how

quickly the shot can be manu-

factured at a plant in Belgium,

but the government is expect-

ing “many millions” of doses

by the end of the year.

People familiar with the

matter said the U.K. might get

four million to five million

doses this year, but the num-

ber will depend on production

and other potential regulatory

authorizations. The U.K. said it

planned to use that limited

supply to start vaccinating

nursing-home residents and

staff, and then move on to

other highly vulnerable groups.

That sets up the U.K. as a

potential test case for how dis-

tribution of the vaccine might

unfold in other countries. The

National Health Service, Brit-

ain’s state-funded health sys-

tem, runs hospitals across the

country, and has been tapped

to distribute the shots.

Pfizer and BioNTech joined

forces at the onset of the virus

outbreak and edged ahead of

two other promising vaccine

candidates, Moderna’s and one

developed by the University of

Oxford andAstraZenecaPLC.

China and Russia have been

vaccinating their populations

with homegrown vaccines, too.

Pfizer in November said tri-

als found its vaccine to be 95%

effective in preventing symp-

tomatic Covid-19. Moderna said

days later its vaccine, developed

with the same genetic technol-

ogy, showed 94.5% efficacy.

Both vaccines use a new

technology, leveraging mRNA,

short for the molecular couri-

ers called messenger RNA that

carry genetic instructions to

cells. The shots deliver mRNA

that prompts cells to make a

synthetic version of the spike

protein that juts from the sur-

face of the new coronavirus.

That triggers the immune sys-

tem to defend against the virus.

The shot developed by Ox-

ford and AstraZeneca works

like a more traditional vaccine,

introducing a weakened virus,

in this case one found in chim-

panzees, into the body to trig-

ger immunity. It showed an ef-

ficacy range of 62% to 90%,

depending on the dosage.

The U.K. has ordered its reg-

ulator to review that vaccine

for emergency use, too. Astra-

Zeneca is still conducting trials

in the U.S. and is expected to

submit its vaccine to the FDA

once it has enough data.

The EMA has said it hopes

to authorize at least one of the

three vaccines by the end of

the year.

Family members wave to Barbara Farrior after a Thanksgiving drive-up visit at The Hebrew Home at Riverdale in New York City.

EDUARDO MUNOZ ALVAREZ/ASSOCIATED PRESS

sible.

The CDC officials encour-

aged people to stay home and

not travel for the coming holi-

days.

For people who do intend

to travel, the CDC officials rec-

ommended people get tested

one to three days before trav-

eling and three to five days af-

terward. People should also

reduce nonessential activities

for seven days after traveling.

If people don’t get tested fol-

lowing travel, they should re-

duce activities for 10 days, the

agency said.

For travel or to end a quar-

antine at seven days, people

can use either a molecular

test, such as a laboratory-

based PCR test, or a rapid an-

tigen test, the agency said.

Molecular tests search for

the virus’s genetic material,

while antigen tests hunt for

proteins that make up the vi-

rus. Both can diagnose an ac-

tive infection, though the lab-

oratory-based PCR tests tend

to be more precise.

Those who are quarantining

because they might have been

exposed to the virus should

get tested five to seven days

after the exposure to end the

quarantine at seven days, the

CDC said.

The agency also recom-

mends that people monitor

themselves for symptoms for

the remainder of the 14 days.

The U.S. Centers for Disease

Control and Prevention short-

ened the recommended quar-

antine period to seven to 10

days for people in the U.S.

who have been exposed to the

new coronavirus, updating its

guidance to reflect scientific

findings on the time it takes

for infections to develop.

The new recommendation,

which the CDC announced

Wednesday, lowers the quar-

antine period from 14 days.

A person can end a self-

quarantine at seven days after

exposure if they test negative

and have no symptoms, the

CDC said. Without a test, a

person should self-quarantine

for 10 days, and monitor

themselves an additional four

days for symptoms, the agency

said. A 14-day quarantine pe-

riod is still “the best way to

reduce risk,” said Henry

Walke, incident manager for

the CDC’s Covid-19 response.

The agency considers the

shorter periods to be alterna-

tives.

The Wall Street Journal re-

ported on Nov. 24 that the

CDC was completing recom-

mendations for a new quaran-

tine period of this length, after

reviewing studies and its own

modeling suggesting that

shorter quarantines were pos-

BYBETSYMCKAY

ANDBRIANNAABBOTT

CDC Shortens

Quarantine for

Virus Exposures

ing new vaccine technology into

a widely available shot. It was

developed, tested, authorized

and is poised to be distributed

amid a pandemic that has killed

more than 1.4 million people.

The U.K.’s emergence as the

first Western country to get a

vaccine is the result of fast work

by the country’s Medicines and

Healthcare products Regulatory

Agency. Britain is transitioning

out of the European Union, with

the exit fully kicking in on Jan.

1. As a member of the bloc, au-
   thorization of the U.K.’s new
   drugs were in the past overseen
   by the European Medicines
   Agency, the EU regulator.
   The MHRA in the past
   worked closely with the EMA,
   handling a significant portion
   of the Europe-wide portfolio
   of medicines and medical de-
   vices awaiting authorization.
   Brexit has meant the work
   the MHRA did for all of Eu-
   rope was reduced significantly,
   freeing up knowledgeable staff
   to move quickly when vaccine
   data became available, re-
   searchers familiar with the
   agency said. While drug au-
   thorization for British citizens
   is still in most cases in the
   hands of the EMA until the
   end of the year, the U.K. gov-
   ernment used a long-held
   power to authorize a drug for
   emergency use, after the
   MHRA signed off on its safety.
   A panel of experts advising

ContinuedfromPageOne

Prime Minister Boris Johnson, center, flanked by U.K. health officials, announced the emergency-use clearance on Wednesday.

JOHN SIBLEY/PRESS POOL

U.K. Clears

Emergency

Vaccine Use

CVS HealthCorp. andWal-

greens Boots AllianceInc. are

preparing to bring Covid-

shots to long-term-care facili-

ties, but the effort will need to

navigate rollout details that

may vary by state, vaccines that

require more than one dose and

potential reluctance by staffers

to get the novel shots.

An advisory panel to the

U.S. government recommended

on Tuesday that residents of

long-term-care facilities be in-

cluded with doctors, nurses

and health-care workers to be

first in line for vaccines. States,

which will ultimately decide

how to allocate Covid-19 vac-

cine supplies, don’t need to fol-

low the guidelines, though they

usually do. But logistics and

other aspects of the effort may

differ among states, even

among those that broadly ac-

cept the panel’s conclusions.

Vaccines are on track for

federal authorization this

month and could begin shipping

within days of receiving clear-

ance, U.S. officials have said.

CVS and Walgreens will deliver

most vaccine doses for the na-

tion’s approximately 15,

nursing homes and 29,000 as-

sisted-living communities.

Hospitals and other medical

clinics are slated to serve as

vaccination sites for health-

care workers in the initial roll-

out, but pharmacy workers are

expected to come to nursing

homes and other adult-care fa-

cilities to deliver and adminis-

ter the vaccines to residents

and, likely, staff.

The long-term care rollout

will be an early test of how

quickly and efficiently CVS,

Walgreens and governments

can distribute Covid-19 vac-

cines, a campaign expected to

last months. They are working

to address storage and trans-

portation issues for vaccines

that need to be kept at colder

temperatures than vaccines for

other diseases, as well as con-

cerns that some residents and

staffers may decline the shots.

Many details of the govern-

ment plans remain unclear,

just weeks before doses might

start being shipped, said nurs-

ing-home industry officials,

and executives with CVS and

Walgreens.

“There’s a lot of uncer-

tainty,” said Richard Feifer,

chief medical officer ofGene-

sis HealthcareInc., the largest

U.S. nursing-home operator.

Also, he said, “there is so much

local autonomy,” meaning

plans and timing will vary

among states.

Still, elder-care facility own-

ers around the country are lay-

ing the groundwork for vac-

cines. Some are launching

campaigns to inform residents,

families and staffers, with the

hope of persuading them to re-

ceive the shots. Nursing homes

often have to get consent

forms signed by family mem-

bers, if residents aren’t able to

do so themselves.

Nursing-home staff and resi-

dents have been especially

hard hit by the virus. Last

week the number of Covid-

deaths in the U.S. linked to

long-term-care facilities sur-

passed 100,000, nearly 40% of

the country’s total.

There are around three mil-

lion beds in U.S. long-term-care

facilities, according to the U.S.

Centers for Disease Control

and Prevention.

Nursing-home groups had

pushed for their residents and

staffers to be included among

those first to get the vaccine,

pointing to the losses caused

by the pandemic and the rising

number of Covid-19 cases in

the facilities in recent weeks.

Nursing-home companies

said they want their staffers to

be able to get the vaccine at

their facilities, at the same

time as residents, though

some states may not choose to

do this.

The U.S. government in Oc-

tober picked CVS and Wal-

greens, which operate about

20,000 stores combined, to ad-

minister vaccinations at elder-

care facilities, though other

pharmacies can participate as

well.

Public-health experts like the

plans, citing the chains’ experi-

ence administering influenza

vaccines at nursing homes. CVS

runs its own long-term-care

pharmacy operation, Omnicare.

Walgreens has a stake in an-

other long-term-care pharmacy

provider, PharMerica.

Flu vaccines are easier to

administer, coming in filled sy-

ringes and stored at refriger-

ated temperatures. The initial

Covid-19 vaccines from Mod-

erna Inc., and Pfizer Inc. and

partner BioNTech SE, need to

be shipped in subzero tempera-

tures and require two doses,

which means at least two trips

to facilities.

About 1,000 CVS pharmacies

will serve as hubs to receive

vaccines from the government

or vaccine makers, with small

teams of pharmacists visiting

25,000 facilities, said Chris

Cox, a CVS executive who is

overseeing the vaccination roll-

out for the pharmacy chain. He

said CVS wants to deliver the

first of two doses within a

month once a state gives the

go-ahead, but said that process

will be sensitive since it is un-

clear when states will make

those calls.

Rick Gates, a senior vice

president at Walgreens, said it

too was planning to set up vac-

cine hubs around the country,

likely around 800 to 1,000, to

distribute shots to about

23,000 long-term-care facili-

ties. States may decide differ-

ently on how the vaccine

should be distributed, he said,

and they can also vary on how

they prioritize the doses. Be-

cause of that, facilities in some

states may get shots before

those in others, he said.

BYJAREDS.HOPKINS

ANDANNAWILDEMATHEWS

Next Step: Protect Elderly

CVS and Walgreens

lay plans to vaccinate

millions of residents

in facilities across U.S.

The nation’s largest, longest

surge of Covid-19 hospitaliza-

tions set another record

Wednesday as the number of

coronavirus patients in U.S.

hospitals surpassed 100,000.

Hospitalizations have been

climbing for more than two

months, roughly double the

length of upswings in the pan-

demic’s prior two surges, to

reach 100,226, Covid Tracking

Project data show. The influx

is widely expected to continue.

Hospitals in some U.S. regions

are already making trade-offs

as staff and space grow scarce.

Doctors and nurses say they

are fearful the weeks ahead

will push hospitals beyond

their limits, with the health-

care workforce stretched thin

after months of repeated

surges and widespread de-

mand nationally.

New Covid-19 hospital pa-

tients follow new coronavirus

cases typically within a few

weeks. Soaring cases nation-

ally have accelerated beyond

public-health agencies’ ability

to rein in contagion by track-

ing infections to head off fur-

ther spread, said Jennifer

Nuzzo, an epidemiologist who

leads the Johns Hopkins Uni-

versity Covid-19 Testing In-

sights Initiative. “We just can’t

keep up,” Dr. Nuzzo said.

The number of new cases

reported has been disrupted

by the Thanksgiving holiday.

The figure Tuesday crossed

180,000, Johns Hopkins Uni-

versity data show, an increase

over the same day a week ear-

lier.

“This surge is getting

worse,” said Janis M. Or-

lowski, chief health-care offi-

cer at the Association of

American Medical Colleges,

which represents medical

schools and their hospitals.

BYMELANIEEVANS

U.S. Hospitalizations

For Covid Top 100,

Nearly40%ofU.S.

Covid-19 deaths are

linked to long-term-

care facilities.

FDA Head Defends

Approval Process

WASHINGTON—Food and

Drug Administration Commis-

sioner Stephen M. Hahn de-

fended his agency’s vetting

process forPfizerInc.’s

Covid-19 vaccine, saying a

thorough and meticulous re-

view is needed to assure a

skeptical public of the vac-

cine’s safety and effectiveness.

In an interview with The

Wall Street Journal, Dr. Hahn

said his agency has had 150

people working days, nights

and weekends in parallel

teams to review the test

data submitted by Pfizer and

German partnerBioNTechSE.

The FDA has also sched-

uled a meeting of an outside

advisory committee for Dec.

10 to review the test data,

which Dr. Hahn said was an-

other step taken to assure

the public amid concerns that

the FDA might rush approval.

“We realize there is an is-

sue in the U.S. around vaccine

hesitancy. There have been

concerns raised about the

speed with which Covid-

vaccines have been devel-

oped,” Dr. Hahn said. “This

will meet our gold standard

of safety and efficacy that

the American people have

come to trust.”

—Thomas M. Burton