The New York Times - USA (2020-12-01)

(Antfer) #1

A4 TUESDAY, DECEMBER 1, 2020


Tracking an Outbreak

N

Another burst of encouraging news about a coronavirus vaccine on
Monday underscored the sunniness about a future that is weeks and
months off, and the desperation about the time between now and
then. November was bleak, with more than 4.35 million new cases in
the United States, slightly less than a third of the nation’s total for
the entire pandemic. As a terrible month ended, there was an omi-
nous sense that a post-Thanksgiving surge was coming.
The encouraging news on Monday came from the drugmaker
Moderna. It said its coronavirus vaccine was especially good at
preventing severe disease among people who contract Covid-19. The
company asked the Food and Drug Administration for an emer-
gency authorization to distribute the vaccine. Stéphane Bancel,
Moderna’s chief executive, said that the first injections could be
given as early as Dec. 21 if the approval process went smoothly. He
said the company was “on track” to make 20 million doses by the
end of the year — enough for 10 million people, because anyone who
receives the vaccine is supposed to be given two doses, a month
apart. An additional 500 million to a billion doses are expected next
year, he said.
There were some signs that don’t-travel-for-Thanksgiving mes-
sages from public health officials got through: Although more than
six million Americans took airline flights last week despite warnings
from public health experts and the Centers and Disease Control and
Prevention, that was only about 40 percent of the number from last
year. Day by day last week, 800,000 to one million people passed
through Transportation Safety Administration checkpoints — far
fewer than during the same period last year, but surely far higher
than epidemiologists had hoped for.
Nor was Black Friday the dependable hit that it was when retail-
ers could count on packed malls to guarantee profits. David Bassuk,
global co-head of the retail practice at the consulting firm Alix Part-
ners, called the day after Thanksgiving this year “bleak Friday,”
adding that stores “really were ghost towns.” Most consumers
shopped online if they shopped at all.
For those who traveled for Thanksgiving, the advice from ex-
perts was pragmatic. No one was blunter than Dr. Deborah L. Birx,
the White House coronavirus task force coordinator. “You have to
assume that you were exposed and you became infected,” she said
on the CBS News program “Face the Nation” on Sunday.
Cases from the holiday will weigh down a map where almost
every region is already a hot spot. Hospitalizations have also
climbed. The Covid Tracking Project said that more than 91,
Americans were hospitalized as of Sunday — almost twice as many
as on Nov. 1 and three times the number on Oct. 1. On Monday, Ohio
reported that more than 5,000 coronavirus patients were hospital-
ized in the state, a record, and that intensive care units at 76 percent
of capacity. Wisconsin’s health department said that only 16 percent
of the hospital beds in the state were available.
In New York, Gov. Andrew M. Cuomo was terse. “We are not
going to live through the nightmare of overwhelmed hospitals
again,” he declared, saying that his state was entering “a new phase
in the war against Covid” — a phase that involves “preparation and
mobilization.” He announced emergency measures to address the
strain that hospitals are facing as cases rise. He also raised the
possibility that a “critical hospitalization situation” could cause the
return of stringent measures from the spring, when he ordered
nonessential businesses statewide to close.
In Rhode Island, state officials sent an emergency alert to cell-
phones that read: “Hospitals at capacity due to COVID. Help the
frontline by staying home as much as possible for the next two
weeks.” Monday was the first day of a two-week pause that required
bars to close, along with bowling alleys, theaters and gyms. But
perhaps more significantly, Rhode Island officials asked residents to
limit their social contacts to only people in their own households.


Positive Signs in Britain


Three weeks into Britain’s national lockdown, new cases have
fallen 30 percent, with even sharper declines in parts of northern
England that had been hit especially hard by the second wave. The
percentage of the population infected in the northwest fell by more
than half, to 1.08 percent by Nov. 24, from 2.53 percent at the end of
October. By contrast, the latest interim findings from Imperial Col-
lege London’s React study showed almost no change in London,
although the researchers appeared to interpret that as a positive
sign, because the rapid rise in cases there had leveled off.
The researchers found that the reproduction number — the “R
number,” an indicator of viral transmission — had fallen to 0.
across Britain. It had not been below 1 since Aug. 14. The reproduc-
tion number is a measure of how many others a single infected
person can be expected to pass the virus along to. An R number of
less than 1 is a sign that an outbreak is waning.
Matt Hancock, the British health secretary, warned that the
React data, while promising, did not mean that Britain could “take
our foot off the pedal just yet,” according to the BBC. He said on
Twitter that “we can see light at the end of the tunnel” with mass
testing and promising vaccine candidates on the horizon.
England’s lockdown is scheduled to end Wednesday. But the way
it ends will vary across the country, as regions move into one of
three tiers based on their infection rates. Which tier an area ends up
in could affect struggling small businesses, which squeaked through
the first lockdown in the spring with financial aid from the govern-
ment. This time around, economic prospects seem shakier. A survey
conducted by the Office for National Statistics in Britain found that
one in seven companies there had “little or no confidence” it would
survive the next three months.


By JAMES BARRON

Coronavirus Update


Coronavirus Update wraps up the day’s developments with infor-
mation from across the virus report.

Moderna Seeks Rapid Review of Vaccine


Concern About Surge After Thanksgiving


More Than 90,000 People in the Hospital


New Coronavirus Cases Announced Daily in U.S.

THE NEW YORK TIMES

March 1 Nov. 30


As of Monday evening, more than 13,575,900 people across every
state, plus Washington, D.C., and four U.S. territories, have tested
positive for the virus, according to a New York Times database.


Note: Monday’s total is incomplete because some states report
cases after press time. Data is as of Nov. 30, 2020, at 5 p.m. Eastern.
Sources: State and local health agencies; hospitals; C.D.C.


New cases

7-day average

120,


60,


Days with a data
reporting anomaly

Average daily cases per 100,000 people
in the past week

25 50 75 125

Hot Spots in the United States

THE NEW YORK TIMES

As of Monday evening, more than 13, 575 ,90 0 people across every state,plus Washington, D.C., and four U.S. territories, have tested positive for the
coronavirus, according to a New York Times database. More than 267 , 600 people with the virus have died in the United States. On Nov. 19, the map
scale was broadened from an upper limit of 48+ to 125+ per 100,000 in order to reflect the new record rates of infection. The map was also changed
so that areas with very low population density are now shaded.

Nev.

Ga.

Miss.

Conn.

N.C.

Iowa

N.D.

Kan.

Te x a s

R.I.

Mass.

Ark.

Utah

Mont.

S.C.

Mich.

Calif.

Wis.

N.M.

Fla.

Wyo.

N.Y.

Ind.

Minn.

Ore.

Maine

Alaska

Tenn.

Pa.

Md.

Ariz.

Wash.

N.H.

Hawaii

Mo.

Del.

W. Va.

N.J.

Idaho

D.C.

Ohio

Ky.

Okla.

La.

Ala.

Vt.

Neb.

S.D.

Colo.
Va.

Puerto Rico

Sources: State and local health agencies. The map shows the share of population with a new reported case over the last week. Data for Rhode Island is shown at
the state level because county level data is infrequently reported. Data is as of Nov. 30, 2020, at 5 p.m. Eastern. Numbers in some states may be artificially low
because of testing and reporting irregularities around Thanksgiving.

Ill.

The drugmaker Moderna an-
nounced highly encouraging re-
sults on Monday, saying that com-
plete data from a large study show
its coronavirus vaccine to be 94.
percent effective, a finding that
confirms earlier estimates.
The company said that it ap-
plied on Monday to the Food and
Drug Administration to authorize
the vaccine for emergency use,
and that if approved, injections for
Americans could begin as early as
Dec. 21.
The hopeful news arrives at a
particularly grim moment in the
U.S. health crisis. Coronavirus
cases have surged and over-
whelmed hospitals in some re-
gions, and health officials have
warned that the numbers may
grow even worse in the coming
weeks because of travel and gath-
erings for Thanksgiving.
The new data from Moderna
show that its study of 30,000 peo-
ple has met the scientific criteria
needed to determine whether the
vaccine works. The findings from
the full set of data match an analy-
sis of interim data released on
Nov. 16 that found the vaccine to
be 94.5 percent effective.
The study also showed that the
vaccine was 100 percent effective
at preventing severe disease from
the coronavirus. The product was
developed in collaboration with
government researchers from the
Vaccine Research Center at the
National Institute of Allergy and
Infectious Diseases.
Stéphane Bancel, the chief ex-
ecutive of Moderna, said in an in-
terview that the company was “on
track” to produce 20 million doses
by the end of December, and from
500 million to a billion in 2021.
Each person requires two doses,
administered a month apart, so 20
million doses will be enough for 10
million people.
Moderna is the second vaccine
maker to apply for emergency use
authorization; Pfizer submitted
its application on Nov. 20. Pfizer
has said it can produce up to 50
million doses this year, with about
half going to the United States. Its
vaccine also requires two doses
per person.
The first shots of the two vac-
cines are likely to go to certain
groups, including health care
workers, essential workers like
police officers, people in other
critical industries, and employees
and residents in nursing homes.
More than 100,000 Covid deaths
have occurred in U.S. nursing
homes and other long-term care
centers.
On Tuesday, a panel of advisers
to the Centers for Disease Control
and Prevention will meet to deter-
mine how to allocate initial sup-
plies of vaccine.
“Be thinking people in nursing
homes, the most vulnerable, be
thinking health care workers who
are on the front lines,” Alex M.
Azar II, the secretary for health
and human services, said on the
CBS program “This Morning” on
Monday.

He said the C.D.C. advisers
would base their recommenda-
tions on the latest data on virus
cases across the country. Asked
about the role of states in the dis-
tribution process, he said that
doses would be shipped out
through normal vaccine distribu-
tion systems, and governors
would be “like air traffic control-
lers,” determining which hospitals
or pharmacies receive shipments.
Although governors will deter-
mine which groups are pri-
oritized, he said he hoped that
they will follow the federal recom-
mendations. He added that he
would speak to governors on Mon-
day afternoon with Vice President
Mike Pence. In response to a ques-
tion about how officials could
guard against people using
money or connections to jump the
proverbial line, Mr. Azar vowed to
“call out any inequities or injus-
tices that we see.”
The White House moved
quickly to take credit for the
progress on vaccines. “President
Trump’s Operation Warp Speed is
rapidly advancing on a trajectory
of success to save millions of
American lives — five times faster
than any other vaccine in history,”
Michael Bars, a spokesman for
Mr. Trump, said in a statement.
Over all, about 13.3 million
Americans have contracted the vi-
rus, and more than 265,900 have
died. In November alone, there
were more than four million new
cases and 25,500 deaths in the
United States. Worldwide, there
have been nearly 62 million cases
and almost 1.5 million deaths.
More than 70 coronavirus vac-
cines are being developed around
the world, including 11 that, like
Pfizer’s and Moderna’s vaccines,
are in large-scale trials to gauge
effectiveness.
One of those is made by As-
traZeneca, which announced pos-
itive but puzzling preliminary re-
sults on Nov. 23: Its vaccine was
90 percent effective in people who
received a half dose and then a full

one, but 62 percent effective in
those who received two full doses.
Researchers are waiting for more
data.
Moderna’s application for emer-
gency use authorization included
data from its Phase 3 study of
30,000 people. The application,
several hundred pages long, also
included several thousand pages
of additional data.
F.D.A. scientists will examine
the information, and the applica-
tion is likely to undergo a final re-
view on Dec. 17 by a panel of ex-
pert advisers to the agency, Mr.
Bancel said, adding that he ex-
pected the advisers to make a de-
cision within 24 to 72 hours. The
F.D.A. usually follows the recom-
mendations of its advisory panels.
Officials at Operation Warp
Speed, the government’s program
to accelerate vaccine develop-
ment, have said vaccinations
could begin within 24 hours after
the F.D.A. grants authorization.
Mr. Bancel said that Moderna
had not yet begun shipping vac-
cines across the country, and that
it would not do so until the emer-
gency authorization was granted.
The government has arranged
to buy vaccines from both Mod-
erna and Pfizer and to provide it to
the public free of charge. Moderna
has received a commitment of
$955 million from the U.S. govern-
ment’s Biomedical Advanced Re-
search and Development Author-
ity for research and development
of its vaccine, and the United
States has committed up to $1.
billion to buy 100 million doses.
Both Moderna’s and Pfizer’s
vaccines use a synthetic form of
genetic material from the corona-
virus called messenger RNA, or
mRNA, to program a person’s
cells to make many copies of a
part of the virus. That viral frag-
ment sets off alarms in the im-
mune system and trains it to rec-
ognize and attack the real virus if
it tries to invade.
No mRNA vaccine has reached
the market before, and the candi-

dates from Pfizer and Moderna
have faced considerable skepti-
cism from scientists and a wary
public.
But the strong results from both
vaccines have begun to quash the
doubts.
So far, neither vaccine has had
serious side effects, but many re-
cipients have had headaches, mild
fevers, fatigue, joint and muscle
aches, and sore arms.
Of the 30,000 people in the Mod-
erna study, half were vaccinated
and half received placebo shots of
salt water; neither the partici-
pants nor their doctors knew who
got what. Then, researchers moni-
tored the participants to see who
contracted the coronavirus and
watched for side effects.
To determine statistically
whether the vaccine was effec-
tive, a total of 151 cases of Covid-
were needed.
Because the coronavirus has
been surging in the United States,
Moderna wound up with 196 cases
— 185 in the placebo group, and 11
in the vaccinated group, meaning
that the vaccine was 94.1 percent
effective at preventing Covid-19.
The 196 people who got sick
with Covid-19 reflected the diver-
sity of Moderna’s volunteers:
Thirty-three were 65 or older. The
group also included 29 Hispanic
volunteers, six Black participants,
four Asian-Americans and three
multiracial people. The efficacy
and safety appeared the same in
all of the subgroups and by gen-
der, Moderna said in its announce-
ment.
Thirty participants had severe
cases, all in the placebo group.
One died.
Mr. Bancel said he considered
the statistics about prevention of
severe disease the most impor-
tant data from the study.
“This is why I think this vaccine
is going to be a game-changer,” he
said. The vaccine will reduce hos-
pitalizations and deaths, he add-
ed, “and I hope get this country
back to its pre-pandemic state.”

VACCINES

Moderna Applies for Emergency F.D.A. Approval


By DENISE GRADY

Stéphane Bancel, Moderna’s chief executive, said there would be 20 million doses by year’s end.

CODY O’LOUGHLIN FOR THE NEW YORK TIMES

Sheryl Gay Stolberg and Karen
Zraick contributed reporting.
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