The Wall Street Journal - USA (2020-12-01)

A8| Tuesday, December 1, 2020 **** THE WALL STREET JOURNAL.

U.S. NEWS

Tech, works about as well as

older vaccines such as measles

and shingles shots.

“The confirmation of high ef-

ficacy in the large sample is tre-

mendous news for this vaccine,”

said Kathleen Neuzil, a professor

of vaccinology at the University

of Maryland School of Medicine.

She said it looks like the shot

could “positively impact the tra-

jectory of the pandemic.”

Because of time constraints,

researchers don’t know

whether inoculation stops the

spread of the virus and how

long the protection against

symptomatic Covid-19 con-

ferred by the vaccine lasts.

Health authorities have

awaited the advent of vaccines

to fight off a virus that has

swamped hospitals with pa-

tients and forced economies to

shut down. Cases are surging in

the U.S. and some other coun-

tries.

Vaccines developed in China

and Russia have already gone

into use, while AstraZeneca PLC

recently said its vaccine was

62% to 90% effective, depending

on the doses taken, in late-stage

trials in the U.K. and Brazil.

AstraZeneca’s vaccine, co-

developed with the University

of Oxford, is on track to go into

distribution in the West before

year-end, though possibly not

in the U.S. if additional testing

is required.

Moderna’s vaccine, like the

one from Pfizer and BioNTech,

uses a gene-based technology

known as messenger RNA after

the molecules that carry DNA

instructions for making pro-

teins.

Virus Was Likely

In U.S. in Late 2019

The new coronavirus in-

fected people in the U.S. in

mid-December 2019, a few

weeks before it was officially

identified in China and about a

month earlier than public health

authorities found the first U.S.

case, according to a govern-

ment study published Monday.

The findings significantly

strengthen evidence suggesting

the virus was spreading around

the world well before public

health authorities and research-

ers became aware, upending ini-

tial thinking about how early and

quickly it emerged.

Scientists at the U.S. Cen-

ters for Disease Control and

Prevention found evidence of

infection in 106 of 7,389 blood

donations collected by the

American Red Cross from resi-

dents in nine states across the

U.S., according to the study

published online in the journal

Clinical Infectious Diseases.

The scientists based their

study on blood samples that the

American Red Cross collected

between Dec. 13 and Jan. 17 and

later sent to the CDC for testing

to see if any had antibodies to

the new coronavirus, which is

named SARS-CoV-2. “SARS-

CoV-2 infections may have been

present in the U.S. in December

2019, earlier than previously rec-

ognized,” the authors wrote.

A person’s immune system

develops antibodies when ex-

posed to a pathogen like a virus

to fight it off. Their presence

suggests exposure to a virus.

The findings suggest there

were isolated cases on the U.S.

West Coast in mid-December,

the scientists wrote. They also

found 67 samples with antibod-

ies in Massachusetts, Michigan,

Wisconsin or Iowa, and Connect-

icut or Rhode Island collected

between Dec. 30 and Jan. 17.

The results add to growing

evidence suggesting Covid-

was present outside China ear-

lier than previously known.

—Betsy McKay

Moderna

Seeks FDA

Approval

to be really a game changer for

this pandemic,” Moderna Chief

Executive Stéphane Bancel said

in an interview. “We think it can

really prevent severe disease.”

If the U.S. Food and Drug

Administration clears the shot,

distribution could start within

weeks.

A panel of outside experts

advising the FDA will meet Dec.

17 to review the evidence for the

company’s vaccine and vote on

whether to recommend that the

agency authorize its emergency

use.

A similar meeting has been

set for Dec. 10 for the Pfizer-Bi-

oNTech vaccine.

The progress is remarkably

quick for vaccines, accomplish-

ing in months what typically

takes a decade.

Moderna designed its vac-

cine with the National Institute

of Allergy and Infectious Dis-

eases in January. The vaccine’s

late-stage, or Phase 3, trial be-

gan in July.

Moderna reported prelimi-

nary results two weeks ago

from the first 95 Covid-19 cases

to emerge in the trial, indicat-

ing the shot was 94.5% effec-

tive and looking safe.

Since then, an additional 101

volunteers developed symptom-

atic disease, enough to finish

the analysis and potentially sat-

isfy regulators.

The most common side ef-

fects, the company said, in-

cluded pain around the injec-

tion site, fatigue and headache.

The results were for adults

18 and older, and the vaccine’s

effectiveness was consistent

across age, race and ethnicity

and gender demographics,

Moderna said.

A committee of outside ex-

perts reviewed the perfor-

mance of the vaccine and re-

ported the results to Moderna.

The performance suggests

Moderna’s vaccine, like the can-

didate from Pfizer and BioN-

Continued from Page One

A Moderna lab in Norwood, Mass., in February. The company has never had a product approved.

ADAM GLANZMAN FOR THE WALL STREET JOURNAL

also a week-over-week decline,

down from 142,734 on Nov. 22.

Weekends often lead to a

decline in reported cases, as

fewer doctors’ offices and

testing sites are open. Thanks-

giving was expected to amplify

that effect on data across the

U.S., with cases projected to

fall in the days following the

holiday before surging as the

backlog of tests makes its way

through local and state report-

ing systems.

Increased travel around the

Thanksgiving period and gath-

erings for the holiday will

likely result in a surge of new

coronavirus cases in the com-

ing weeks, scientists and pub-

lic-health experts say, further

accelerating the spread of

Covid-19.

Leading infectious-disease

experts and epidemiologists

are urging Americans to take

preventive steps now, espe-

cially after gathering or trav-

eling for Thanksgiving, by

quarantining at home and get-

ting tested to lessen the po-

tential spread.

More than 1.1 million people

traveled through TSA check-

points Sunday, the highest

number recorded since mid-

March. The Sunday after

Thanksgiving is historically

one of the busiest days for

travel of the year. In 2019, 2.

million passengers passed

through TSA checkpoints.

The number of travelers re-

corded by TSA has surpassed

one million only on four other

days during the pandemic—

once in October, and the rest

in November before and after

the holiday. On Wednesday,

the day before Thanksgiving,

there were 1.07 million travel-

ers, the second-highest num-

ber recorded during the pan-

demic, according to the

agency’s figures.

Epidemiologists say the im-

pact of holiday travel and

gatherings likely won’t be

known for a week or two,

based on the incubation pe-

riod for the virus. Thanksgiv-

ing also likely disrupted new

case reports around the coun-

try in recent days, a common

occurrence following holidays

and over weekends.

A week before Thanksgiv-

ing, the U.S. Centers for Dis-

ease Control and Prevention

urged Americans to stay home

for the holiday as coronavirus

cases surged in nearly every

The vaccines carry genetic

code that teaches human cells

how to produce a protein resem-

bling the spike protein found on

the surface of the coronavirus.

Health officials and scien-

tists view mRNA as a promising

new way to make vaccines, but

no such vaccine has been li-

censed for use before.

It is unclear how long the

FDA will take to make a deci-

sion on permitting use. Mr.

Bancel said it is possible the

agency could decide within a

few days of the Dec. 17 advisory

panel meeting.

Given the urgent need, the

FDA plans to conduct a faster

review than it normally would,

resulting in an authorization

for emergency use.

Moderna expects to have 20

million doses by the end of the

year, enough for about 10 mil-

lion people. Pfizer also expects

to have a limited supply of its

vaccine this year.

Given the limited initial sup-

plies, health officials might de-

cide to first vaccinate front-line

health workers such as those in

hospitals and nursing homes,

and first responders.

A panel of experts advising

the U.S. Centers for Disease

Control and Prevention is sched-

uled to meet Tuesday to vote on

recommendations for who

should get vaccinated first.

Moderna, a 10-year-old bio-

tech in Cambridge, Mass., with

more than 1,200 employees, has

never had a product approved.

To meet the demand for a

Covid-19 vaccine, the company

has been expanding production

capacity, including through a

partnership with contract man-

ufacturer Lonza Ltd.

The federal government has

agreed to purchase 100 million

doses of Moderna’s vaccine for

about $1.5 billion, with an op-

tion to buy more. The govern-

ment also has supply deals with

other leading vaccine develop-

ers such as Pfizer, Johnson &

Johnson and AstraZeneca.

The government is working

with state and local immuniza-

tion programs to get the shots

into the arms of people, though

plans aren’t completed.

Moderna shares rose 20% to

$152.74 Monday. The stock

traded just below $20 at the

start of the year.

state. Now, in the days after

the holiday, epidemiologists

are encouraging Americans

who did travel or gather in

groups to quarantine at home

or get tested to slow any fur-

ther spread of the virus.

Experts worry various fac-

tors could compound the vi-

rus’s spread. The onset of

cooler temperatures and

shorter daylight hours, which

may prompt Americans to

head indoors where the virus

is more easily transmittable,

add to the risks created by in-

creased holiday gatherings

and related travel, said Philip

J. Landrigan, director of the

Global Public Health Program

at Boston College.

“I’m concerned that we’re

coming into a perilous time,”

Dr. Landrigan said Monday.

The number of coronavirus-

related hospitalizations in the

U.S. hit another record, with

more than 93,000 people ad-

mitted as of Sunday, according

to the Covid Tracking Project.

The U.S. reported 138,

new confirmed infections for

Sunday, according to data

compiled by Johns Hopkins

University. That is down from

155,596 a day before and the

record 205,557 reported on

Friday. Sunday’s figure was

BYADAMMARTIN

ANDJENNIFERCALFAS

Over 93,000 Hospitalized for Covid

Record number comes

as experts fear spike

in cases after a busy

holiday travel period

People lined up in their vehicles to get tested for Covid-19 at Dodger Stadium in Los Angeles on Monday. Almost 140,000 new cases in the U.S. were reported Sunday.

MARIO TAMA/GETTY IMAGES

A panel of vaccine experts

advising the U.S. government

is expected to recommend

Tuesday who should get initial

limited supplies of Covid-

vaccines, a key step in rolling

out shots that are authorized.

Expected to be first in line:

Health workers treating coro-

navirus patients and in some-

thing of a surprise, nursing-

home residents.

The Advisory Committee on

Immunization Practices, the

outside medical experts advis-

ing the U.S. Centers for Dis-

ease Control and Prevention,

will vote on who should get

the first doses, after discuss-

ing plans for distributing the

shots and monitoring for po-

tential side effects.

The CDC usually follows the

recommendation of its advi-

sory panel, known as ACIP.

Some states, which ultimately

would decide how to allocate

Covid-19 vaccine supplies, have

been waiting for the recom-

mendations. States have until

Friday to indicate to the fed-

eral government where they

want their initial doses sent.

The 14-member panel is

holding an emergency session

as the U.S. Food and Drug Ad-

ministration weighs authoriz-

ing use of vaccines developed

by Moderna Inc. and by Pfizer

Inc. and partner BioNTech SE.

Both vaccines were shown

to be more than 94% effective

and generally safe in late-

stage testing and could be au-

thorized within weeks.

Initial supplies won’t be

enough to vaccinate many peo-

ple. Pfizer and BioNTech said

they would deliver about 25 mil-

lion doses by year’s end, poten-

tially enough for about 12.5 mil-

lion people in the U.S. Moderna

projects about 20 million doses.

The committee is set to vote

Tuesday on the first set of

people who should get access.

BYJAREDS.HOPKINS

ANDBETSYMCKAY

Panel to

Consider

Who Will

Be First to

Get Doses

WASHINGTON—Scott Atlas,

a coronavirus adviser to Presi-

dent Trump who argued

against lockdowns and sparred

with health experts, has re-

signed, according to a White

House official.

Dr. Atlas was brought on in

August after a string of appear-

ances on Fox News in which he

made comments that aligned

with Mr. Trump’s views, includ-

ing calling for ending lock-

downs and reopening schools.

The appointment came after

Mr. Trump had sidelined Dr.

Anthony Fauci, director of the

National Institute of Allergy

and Infectious Diseases, who

has advocated for stricter mea-

sures to combat the coronavi-

rus’s spread.

In his resignation letter,

dated Dec. 1, Dr. Atlas wrote, “I

worked hard with a singular fo-

cus—to save lives and help

Americans through this pan-

demic.” He said he “always re-

lied on the latest science and

evidence, without any political

consideration or influence.”

Dr. Atlas was serving on a

130-day detail that was set to

expire this week.

A senior fellow at the con-

servative Hoover Institution at

Stanford University, Dr. Atlas

backed approaches to handling

the pandemic that ran counter

to prevailing public health ad-

vice. He supported more pro-

tective measures for people

who were vulnerable, such as

seniors, while letting the virus

circulate among younger people

in an approach described by

some critics as herd immunity.

He criticized the widespread

use of masks to control the

spread of the virus even as the

Centers for Disease Control and

Prevention urged people to

wear them.

BYALEXLEARY

ANDSTEPHANIEARMOUR

Trump

Pandemic

Adviser

Resigns