The New York Times - USA (2020-07-22)

THE NEW YORK TIMES, WEDNESDAY, JULY 22, 2020 N A

Tracking an OutbreakThe Research

Executives from four compa-

nies in the race to produce a coro-

navirus vaccine — AstraZeneca,

Johnson & Johnson, Moderna

Therapeutics and Pfizer — told

lawmakers on Tuesday that they

are optimistic their products

could be ready by the end of 2020

or the beginning of 2021. All four

companies are testing vaccines in

human clinical trials.

Three of the firms — As-

traZeneca, Johnson & Johnson

and Moderna — are getting fed-

eral funds for their vaccine devel-

opment efforts. AstraZeneca and

Johnson & Johnson pledged to the

lawmakers that they would

produce hundreds of millions of

doses of their vaccines at no profit

to themselves. Moderna, however,

which has been granted $483 mil-

lion from the government to de-

velop its product, made no such

promise.

“We will not sell it at cost,” said

Dr. Stephen Hoge, the president of

Moderna.

Many Democratic lawmakers

have argued that federal funding

for vaccine development should

include provisions to guarantee

affordability and guard against

profiteering.

At the Congressional hearing

on Tuesday, some House mem-

bers raised concerns about Pfi-

zer’s decision to reject federal

funds, suggesting it could lead to

price-gouging and a lack of trans-

parency.

“We didn’t accept the federal

government funding solely for the

reason that we wanted to be able

to move as quickly as possible

with our vaccine candidate into

the clinic,” said John Young, Pfi-

zer’s chief business officer.

“We’ll price our potential vac-

cine consistent with the urgent

global health emergency that

we’re facing,” Mr. Young said, add-

ing that “a vaccine is meaningless

if people are unable to afford it.”

Representative Dr. Raul Ruiz,

Democrat of California, also ques-

tioned whether failing to address

the financial stakes of vaccine de-

velopment early on could keep

these products out of “the hands of

the people that need this most.”

“I don’t want to look back, and

then have health equity be an af-

terthought,” Dr. Ruiz said. “It has

to be prioritized.”

The hearing held by members

of the House energy committee’s

oversight panel was punctuated

by notes of optimism from execu-

tives from each company, several

of whom referred to promising

early results from studies in peo-

ple. On Monday, AstraZeneca and

Pfizer released data indicating

that their vaccines could stimu-

late strong immune responses

with only minor side effects.

Still, the actual effectiveness

and durability of these responses

against the virus have yet to be de-

termined. No vaccine candidates

have been proven effective for

preventing infection by the coro-

navirus, or for protecting people

from the severe effects of

Covid-19, the disease caused by

the virus.

Panel members pressed the

company executives for a com-

mitment to maintain the highest

standards for a vaccine, and not

sacrifice quality for the sake of ex-

pediency. An ideal vaccine, sev-

eral committee members

stressed, would not only be safe

and effective, but also be straight-

forward enough to manufacture

en masse and available to the pub-

lic at low cost.

“It is possible that a Covid-

vaccine may become available by

the end of this year or early next

year,” said Representative Diana

DeGette, Democrat of Colorado

and the panel’s chairperson.

“That’s a rare bit of good news in

this harrowing time.”

But, she added, “we must re-

mind ourselves that plenty can

still go wrong. And so the antici-

pated timeline is not guaranteed.”

A fifth contender, Merck,

painted a far less rosy picture of

the landscape. Dr. Julie Gerber-

ding, the company’s executive

vice president and chief patient of-

ficer, made no promises about

when its product would be ready,

citing concerns about safety

should the process be rushed. “We

do not expect to be able to acceler-

ate the safety assessment,” Dr.

Gerberding said.

Merck’s chief executive, Ken-

neth Frazier, has previously cau-

tioned against coronavirus vac-

cine hype and warned that a hur-

ried approval process could dam-

age prospects for protecting the

public.

In a statement released on June

30, the Food and Drug Adminis-

tration noted that any vaccine

candidate vying for approval

would need to prevent or amelio-

rate disease in at least 50 percent

of the people who received it.

PRICING DEBATE

Some Firms

Plan to Profit

From Making

A Vaccine

By KATHERINE J. WU

As criticism of the Trump ad-
ministration’s response to the co-
ronavirus pandemic intensifies, a
former director of the Centers for
Disease Control and Prevention
on Tuesday called on state health
officials to start reporting coro-
navirus data in a detailed and uni-
form fashion, rather than the dis-
organized hodgepodge most
states now produce.
Other public health experts said
that such guidelines were long
overdue and that the agency’s
current director, Dr. Robert Red-
field, should have mandated them
months ago.
The lack of clear C.D.C. guid-
ance — even on simple issues like
data collection — was an example
of the administration’s ineptitude
and ineffective leadership in the
face of a growing crisis, experts
said.
“We have a real vacuum of lead-
ership at the national level,” said
Dr. Thomas R. Frieden, the former
C.D.C. director, who now runs Re-
solve to Save Lives, a nonprofit
health advocacy initiative.
“Absent a national strategy, our
best hope is to get all 50 states on
the same page, so we know where
we are,” he said.
Dr. Frieden’s organization con-
cluded that states are reporting
only 40 percent of the data needed
to fight the pandemic. Some states
disclose less useful information
than the government of Uganda,
which Resolve to Save Lives also
advises on its coronavirus re-
sponse, he said.
The report laid out 15 indicators
that every state should report
daily on a public “dashboard” that
anyone can view.
They included not just basic ele-
ments like cases, hospitalizations
and deaths, but sophisticated met-
rics such as what percentage of in-
fections came from clusters of
people who know one another,
how many health care workers
get infected on the job, how long it
takes to get a diagnostic test re-
sult, and what percentage of any
city’s or county’s residents are

wearing masks.

Dr. Frieden also suggested

tracking how many people in any

city are hospitalized with coro-

navirus or flu symptoms, regard-

less of test results. Where legally

possible, he said, states should

name institutions with major out-

breaks, including nursing homes,

prisons, schools or meatpacking

plants.

Leading public health experts

asked why the C.D.C. itself had not

been requiring such data from

states. Dr. Irwin E. Redlener,

founding director of Columbia

University’s National Center for

Disaster Preparedness, said it

was “pathetic” that a private orga-

nization had to propose data

standards and recruit states to

voluntarily agree.

“The feds should have been de-

manding exactly this kind of

standardized information from

every state and territory since

March,” he said. “This is another

illustration of the failures of the

federal government — Trump was

explicit in telling governors that

they were on their own.”

Michael T. Osterholm, director

of the Center for Infectious Dis-

ease Research and Policy at the

University of Minnesota, who

helped design the data dashboard

used by New York State and cited

by Gov. Andrew M. Cuomo during

his news conferences, said Dr.

Frieden’s proposal was “some-

thing we need in our tool kit that’s

been absent.”

Dr. Osterholm worried that both

spread of the virus and progress

against it were not being ad-

equately measured. “Without

standards, how do you know

whether you’re failing or succeed-

ing?” Dr. Osterholm said. “With-

out them, you can’t hold anyone’s

feet to the fire. This is something

the C.D.C. should have done.”

Dr. Anthony S. Fauci, director of

the National Institute of Allergy

and Infectious Diseases and the

senior scientist on the White

House Coronavirus Task Force,

agreed that Dr. Frieden’s initiative

was an important effort.

Asked for comment, a spokes-

man for the C.D.C., Tom Skinner,

said the agency “was always look-

ing at best practices” and had

made plans with the states to

track 14 of the 15 indicators cited

in Dr. Frieden’s report.

The exception was the percent-

age of people correctly wearing

masks in public, since it was un-

clear how that could be done, Mr.

Skinner said. (Dr. Frieden’s report

suggested doing street counts or

viewing security camera footage.)

When the data are gathered,

they will be posted on the C.D.C.’s

Covid Tracker website, Mr. Skin-

ner said. The Health and Human

Services Department recently

suggested that coronavirus data

from hospitals would be sent to

Washington first, not the C.D.C.,

as has long been done.

Last week, discussing whether

his proposed metrics would be

adopted by the states, Dr. Frieden

said he had consulted with the Na-

tional Governors Association and

several governors had said they

would soon adopt his guidelines.

“We’re hoping peer pressure will

bring along the others,” he added.

The lack of uniform metrics has

contributed to the country’s fail-

ing response to the pandemic, Dr.

Frieden said.

“It’s impossible to exaggerate

how much of an outlier the U.S. is

on reporting data,” he said. “Hong

Kong can have 67 cases and think

it’s a serious situation. We can

have 67,000 cases and there’s a de-

bate about whether it’s serious.”

No state now reports all the

data that are needed, but some are

better than others. Dr. Frieden

singled out Minnesota and Ari-

zona as the overall leaders, while

Oregon and Virginia, he said, were

doing best at reporting one metric

crucial to slowing the spread: con-

tact tracing.

Asian and European countries

rely heavily on tracing and testing

all contacts of each known case. In

most states in this country,

caseloads are increasing so fast

that tracing dozens of contacts of

each patient has become impossi-

ble.

Information about contact trac-

ing is generally “abysmal,” Dr.

Frieden said. “Uganda does better

at tracing and contacting people

in quarantine and reporting it.”

Dr. William Schaffner, a preven-

tive medicine specialist at Van-

derbilt University’s medical

school, welcomed Dr. Frieden’s

proposed standards but said few

states had the expertise and

money needed to generate and an-

alyze the data.

“This is the Platonic ideal for

how state health departments

shouldfunction, but it’s some dis-

tance from the way they canfunc-

tion,” he said. After two decades of

budget cuts, “they are strapped in

personnel and technology.”

Hospitals also find it hard to re-

port data during crises, he added.

FINDING CASES

Former Chief of Health Agency Urges States to Standardize Data

By DONALD G. McNEIL Jr.

“We have a real vacuum of leadership at the national level,” said Dr. Thomas R. Frieden.

KEVIN D. LILES FOR THE NEW YORK TIMES

The number of people infected
with the coronavirus in different
parts of the United States was
anywhere from two to 13 times
higher than the reported rates for
those regions, according to data
released Tuesday by the Centers
for Disease Control and Preven-
tion.
The findings suggest that large
numbers of people who did not
have symptoms or did not seek
medical care may have kept the
virus circulating in their commu-
nities.
The study indicates that even
the hardest-hit area in the study —
New York City, where nearly one
in four people has been exposed to
the virus — is nowhere near
achieving herd immunity, the lev-
el of exposure at which the virus
would stop spreading in a particu-
lar city or region. Experts believe
60 percent of people in an area
would need to have been exposed
to the coronavirus to reach herd
immunity.
The analysis, based on antibody
tests, is the largest of its kind to
date; a study of a subset of cities
and states was released last
month.
“These data continue to show
that the number of people who
have been infected with the virus
that causes Covid-19 far exceeds
the number of reported cases,”
said Dr. Fiona Havers, the C.D.C.
researcher who led the study.
“Many of these people likely had
no symptoms or mild illness and
may have had no idea that they
were infected.”
About 40 percent of infected
people do not develop symptoms,
but they may still pass the virus
on to others. The United States
now tests roughly 700,000 people
a day. The new results highlight
the need for much more testing to
detect infection levels and contain
the viral spread in various parts of
the country.
For example, in Missouri, the
prevalence of infections is 13
times the reported rate, suggest-
ing that the state missed most
people with the virus who may
have contributed to its outsized
outbreak.
Dr. Havers emphasized that
even those who do not know their
infection status should wear cloth
face coverings, practice social dis-
tancing and wash their hands fre-
quently.
The researchers analyzed blood
samples from people who had rou-
tine clinical tests or were hospital-
ized to determine if they had anti-
bodies to the coronavirus — evi-
dence of prior infection. They had
released early data from six cities

and states in June. The study pub-

lished in the journal JAMA on

Tuesday expands that research by

including four more regions. They

also posted data from later time

periods for eight of those 10 sites

to the C.D.C.’s website on Tuesday.

The results indicate that in vast

swaths of the country, the coro-

navirus still has touched only a

small fraction of the population. In

Utah, for example, just over 1 per-

cent of people had been exposed

to the virus by early June. The

rate was 2.2 percent for Minne-

apolis-St. Paul as of the first week

of June, 3.6 percent for the Phila-

delphia metropolitan region as of

May 30 and 1 percent for the San

Francisco Bay Area as of April 30.

In some regions, the gap be-

tween estimated infections and

reported cases decreased as test-

ing capacity and reporting im-

proved. New York City, for exam-

ple, showed a 12-fold difference

between actual infections and the

reported rate in early April, and a

10-fold difference in early May.

“This is not coming as a shock

or surprise to epidemiologists,”

Carl Bergstrom, an infectious dis-

eases expert at the University of

Washington in Seattle, said in an

email. “All along, we have ex-

pected that only about 10 percent

of the cases will be reported.”

Tracking the numbers over

time can provide useful insights

into the virus’ spread and about a

region’s capacity to cope with the

epidemic, other experts said.

“The fact that they’re sort of

marking it out over time and look-

ing at it over a longer duration will

actually be super-informative,”

said Dr. Rochelle Walensky, a re-

searcher at Harvard University

who wrote an editorial accompa-

nying the JAMA paper.

For example, South Florida

ticked up to 2.9 percent as of April

24 from 1.9 percent just two weeks

earlier. Missouri’s numbers

barely budged from 2.7 percent as

of April 26 to 2.8 percent as of May

30. Numbers for both regions are

likely to be much higher in the

next round of analyses because of

the surge of infections in those re-

gions since those dates.

New York City showed the big-

gest leap in its rate, from 6.9 per-

cent as of April 1 to 23.3 percent as

of May 6, consistent with its out-

break.

The city’s estimate closely

matches the 22.7 percent preva-

lence found by a state survey,

which tested patrons in super-

markets from April 19-28.

Some experts criticized the

state survey at the time because

people shopping during the lock-

down were more likely to be

young, or might have recovered

from illness and felt safe.

“These consistent results offer

mutual support to two very differ-

ent methods used,” Eli Rosenberg,

an epidemiologist at the State Uni-

versity of New York at Albany and

lead author of the state study.

The C.D.C. study also has limi-

tations, Dr. Walensky said, be-

cause many of the people who

ventured out during the lock-

downs for tests or were hospital-

ized would have been severely ill,

and might not have been repre-

sentative of the general popula-

tion.

Each region also varied “in

terms of where they were on their

own epidemic curve and varied in

terms of the amount of testing that

they did,” she said.

The study also did not collect

data on race, ethnicity, diagnostic

and symptom history or preven-

tion behaviors, Dr. Rosenberg

said. “The approach used in the

grocery store study allows for

these data collections by pairing

the specimen collection with a

survey,” he said.

Still, experts said the findings

were valuable, despite limitations.

“This population may not be ex-

actly representative of the popula-

tion as a whole, but the hope is

that it is close enough to allow us

to draw meaningful conclusions,”

Dr. Bergstrom said.

Several recent studies have

suggested that antibody levels,

especially in people with mild or

no symptoms, may quickly de-

cline. If that’s true, surveys like

the C.D.C.’s might reflect only peo-

ple who were infected within the

previous two to three months, Dr.

Rosenberg said, “and complicate

interpretation of results over

time.”

THE NUMBERS

C.D.C. Finds Big Differences in Infections vs. Reported Cases

Testing at Dodger Stadium in Los Angeles. About 40 percent of infected people develop no symptoms but can still pass on the virus.

LUCY NICHOLSON/REUTERS

By APOORVA MANDAVILLI

A study of antibody

data points to a need

for more testing.