The New York Times - USA (2020-08-03)

THE NEW YORK TIMES, MONDAY, AUGUST 3, 2020 N A

global potential for cutting cor-
ners.
Despite concerted efforts by the
Trump administration and a bevy
of pharmaceutical companies it is
working with, the original October
target has slipped, with the ad-
ministration now pushing to have
hundreds of millions of doses
available by the end of the year or
early 2021.
But experts inside and outside
the government still say they fear
the White House will push the
Food and Drug Administration to
overlook insufficient data and
give at least limited emergency
approval to a vaccine, perhaps for
use by specific groups like front-
line health care workers, before
the vote on Nov. 3.
“There are a lot of people on the
inside of this process who are very
nervous about whether the ad-
ministration is going to reach
their hand into the Warp Speed
bucket, pull out one or two or three
vaccines, and say, ‘We’ve tested it
on a few thousand people, it looks
safe, and now we are going to roll
it out,’ ” said Dr. Paul A. Offit of the
University of Pennsylvania, who
is a member of the Food and Drug
Administration’s vaccine advi-
sory committee.
“They are really worried about
that,” he added. “And they should
be.”
Mr. Trump relentlessly touts
progress toward a vaccine, raising
hopes of quick approval. Touring a
North Carolina biotechnology lab
last week, he vowed to “deliver a
vaccine in record time.” In a tweet
last month, he explicitly tied vac-
cines to his re-election hopes.
On a campaign call with sup-
porters in Pennsylvania on Sun-
day evening, Mr. Trump said the
“F.D.A. has been great, at my in-
struction,” and he again raised
hopes of rapid progress.
“We expect to have a vaccine
available very, very early before
the end of the year, far ahead of
schedule,” he said. “We’re very
close to having that finalized.”
The president’s son-in-law and
senior adviser, Jared Kushner,
who is helping to steer the re-elec-
tion campaign from the White
House, is a regular participant in
meetings of a board formed to
oversee the vaccine effort.
While White House officials do
not specifically mention the elec-
tion during the board’s discus-
sions, people familiar with the
conversations say they ask regu-
larly about October, a date that
hangs over the effort. Trump cam-
paign advisers privately call a
pre-election vaccine “the holy
grail.”
The Food and Drug Administra-
tion’s approval of a new vaccine is
typically an exhaustive process,
where agency employees meticu-
lously go through data from clini-
cal trials to review whether the
vaccine is both safe and effective.
The threshold for approving vac-
cines is typically higher than it is
for therapeutic drugs because
they will be used in millions of oth-
erwise healthy people, meaning
that even rare side effects could
affect many more people than a
drug that treats a specific illness.
An independent advisory panel
of outside experts also weighs in,
and while the agency has the
power to make its own decision, it
typically follows the advice of its
outside panels. The Food and
Drug Administration’s senior reg-
ulator has the power to approve or
deny vaccines for emergency use,
but that decision could be overrid-
den by the agency’s top leaders, or
by the secretary of health and hu-
man services.
White House officials said that
Mr. Trump would not distort the
vaccine review process to help his
campaign. “The rapid research,
development, trials and eventual
distribution of a Covid-19 vaccine
is emblematic of President
Trump’s highest priority: the
health and safety of the American
people,” said Judd Deere, a White
House spokesman. “It has noth-
ing to do with politics.”
Dr. Anthony S. Fauci, the direc-
tor of the National Institute of Al-
lergy and Infectious Diseases,
told lawmakers on Friday that he
remained “cautiously optimistic
that we will have a vaccine by the
end of this year and as we go into
2021.”
Dr. Stephen Hahn, the commis-
sioner of the Food and Drug Ad-
ministration, has not ruled out
emergency approval of a vaccine.
“We would consider using an
emergency use authorization if
we felt that the risks associated
with the vaccine were much lower
than the risks of not having a vac-
cine,” he told The Journal of the
American Medical Association in
an online interview.
He also said regulators would
certify that any vaccine would
meet the agency’s rigorous stand-
ards, adding, “My job as commis-
sioner is to make sure to the fullest
extent possible that any pressure

that comes to the agency is not re-

flected downward” onto regula-

tors and scientists studying the

vaccines.

Operation Warp Speed got its

start in April, the brainchild of Dr.

Peter Marks, a pencil-thin, be-

spectacled physician who leads

the regulatory unit at the Food

and Drug Administration that ap-

proves vaccines and therapies.

A “Star Trek” fan, Dr. Marks

named the initiative Warp Speed

and pitched it in an April 10 phone

call to Alex M. Azar II, the secre-

tary of health and human serv-

ices, who quickly embraced it. In a

follow-up phone call a few days

later, according to a person famil-

iar with the discussions, several

health officials said the October

deadline was unrealistic; over the

next few months, officials began

publicly citing the end of the year

or early 2021 as a target.

With his job on the line, Mr.

Azar, the target of Mr. Trump’s

wrath over the virus, was espe-

cially eager to prove his worth to

the White House. He teamed up

with Defense Secretary Mark T.

Esper, whose department has

long experience with vaccine de-

velopment and distribution to pro-

tect troops. An expert in complex

logistics, Gen. Gustave F. Perna,

became the operation’s chief oper-

ating officer.

Mr. Kushner, Dr. Deborah L.

Birx, the White House coro-

navirus coordinator, and others

interviewed Dr. Moncef Slaoui, a

pharmaceutical industry veteran,

and orchestrated his appointment

as chief scientific adviser despite

concerns within the Food and

Drug Administration about con-

flicts of interest because of his fi-

nancial ties to two companies that

are developing a vaccine. Rather

than being bothered by the con-

flict, Mr. Kushner and others rea-

soned that it took someone with

such industry experience to over-

see the effort.

Dr. Slaoui resigned from the

board of Moderna, which has re-

ceived nearly $1 billion in federal

support to develop a vaccine. But

as of May he still had nearly $

million of stock in GlaxoSmith-

Kline, a partner with the French

drugmaker Sanofi, which last

week signed a $2.1 billion agree-

ment to produce 100 million doses.

Dr. Slaoui, who is working on a $

contract, cleared an ethics review

by the Department of Health and

Human Services and has said he

is determined to avoid any con-

flict.

Shortly after Dr. Slaoui’s ap-

pointment, Dr. Marks resigned

from the project he conceived and

returned full-time to his post as a

senior regulator at the Food and

Drug Administration, where he

will be the key decision maker on

whether a vaccine merits approv-

al.

The administration has con-

ducted the vaccine hunt with a fo-

cus lacking in much of the rest of

its pandemic response. Contracts

have been executed at a brisk

pace. Mobile trailers have been

speedily delivered for experi-

mental doses to be administered.

When a company was short on

needles, the Pentagon dispatched

planes to deliver supplies within

48 hours.

The pharmaceutical companies

are reporting the results of their

trials at regular intervals, acceler-

ating the review process. With the

government paying much of the

cost, the companies are beginning

the process of manufacturing mil-

lions of doses of vaccine essen-

tially on spec so that they can be

distributed quickly if they secure

approval.

The process has moved at a re-

markable clip. Two vaccine candi-

dates, one developed by Moderna

in conjunction with Dr. Fauci’s in-

stitute and another by Pfizer, last

week began Phase 3 trials, the fi-

nal stage of clinical experi-

mentation. Others are expected

soon.

In Mr. Azar’s conference room

at the Department of Health and

Human Services headquarters,

Mr. Kushner and Dr. Birx join

meetings with Mr. Azar, Mr. Esper

and others. Mr. Kushner repeat-

edly pushes the group to move

faster and has deputized two close

associates, Brad Smith and Adam

Boehler, to press the case.

The team has sought to ensure

that a variety of different types of

potential vaccines are being pur-

sued to increase the chances that

at least one will work. Dr. Birx has

been interested in what is known

as a subunit protein vaccine, and

at one point called executives at

the biotechnology company

Genentech and asked what they

could do. (Warp Speed is now

working with two companies pur-

suing that type of vaccine.)

Mark Meadows, the White

House chief of staff, also talks with

pharmaceutical executives. Peo-

ple briefed on the discussions say

the White House has also pushed

for progress by the fall on thera-

peutics — drugs to treat people

who fall ill to the disease — includ-

ing the possibility of an emer-

gency use authorization for one or

more of those drugs. Late last

month, Mr. Trump called the chief

executive of Regeneron Pharma-

ceuticals to check on the progress

of a potential antibody treatment.

Career officials have assured

Dr. Hahn that they would stand

behind him to head off any vaccine

decision not based on science. But

Dr. Hahn already lost a measure of

credibility with the scientific com-

munity for approving the emer-

gency use of hydroxychloroquine

and chloroquine, two anti-malaria

drugs promoted by the president

as treatments for the coronavirus

over the objections of his public

health advisers. The Food and

Drug Administration later re-

voked the authorization, conclud-

ing the risks outweighed the bene-

fits.

Scientists have argued that it

would be unwise to cut corners on

a vaccine that is to be injected into

some 300 million Americans, add-

ing that a failed effort would fuel

public distrust of vaccines gener-

ally.

But a senior White House offi-

cial, who discussed the matter on

the condition of anonymity, said

that it would also be unethical to

withhold an effective vaccine for

an extra three or four months

while more people died just to

check the boxes of a more routine

trial process.

Michael R. Caputo, a spokes-

man for Mr. Azar, said October

was not the goal.

“Everybody at H.H.S. hopes

Operation Warp Speed will

achieve 300 million doses of a safe

and effective Covid vaccine for

Americans by January 2021,” he

said. “We know that’s optimistic. I

have never heard mention of any

other timeline, and certainly not

from the secretary.”

Mr. Caputo rejected sugges-

tions that a vaccine would be ap-

proved before it was ready. “Care-

less talk about career F.D.A. regu-

lators somehow approving an un-

safe and ineffective vaccine just

for politics only undermines confi-

dence in the public health sys-

tem,” he said.

It is not clear that a vaccine ap-

proval shortly before the election

would be an “October surprise”

sufficient to alter the outcome of

the vote. An announcement could

give Americans hope that the end

is in sight. But some Republican

strategists said that it might not

help Mr. Trump because his oppo-

nent, former Vice President Jo-

seph R. Biden Jr., the presumptive

Democratic nominee, would

surely continue the vaccine

process if elected.

“Does it turn everything around

for him politically? I don’t know,”

said Sarah Longwell, a conserva-

tive strategist and prominent Re-

publican opponent of Mr. Trump

who regularly conducts focus

groups and has found that public

attention is more focused on gov-

ernment relief checks and school

reopenings.

“If the vaccine is an October

surprise, there’s a lot of other

things that are cutting against” it

as a game-changer, she said.

The drug companies find them-

selves caught in the middle. While

eager to bring products to market

as quickly as possible, they face

risks in moving too quickly in or-

der to fit an election calendar, ana-

lysts said.

“They are acutely aware of the

political dynamic here,” said Rob

Smith, the director of Capital Al-

pha Partners, a research firm. A

vaccine that flopped would jeopar-

dize their broader business, he

said, and it would not make sense

“to take a huge reputational risk

not just for your vaccine but for all

the products across your portfolio

to benefit the president political-

ly.”

Dr. Fauci has expressed confi-

dence that the system will hold.

“Historically, the F.D.A. has

based their decisions on science,”

he told a House committee last

week. “They will do so this time

also, I am certain.”

MEDICAL TRIALS

Scientists Fret as Trump Administration Urges Speedy Vaccine Process

From Page A

President Trump has been relentlessly promoting the administration’s vaccine efforts, which have been led by Operation Warp Speed.

ANNA MONEYMAKER FOR THE NEW YORK TIMES

Dr. Stephen Hahn, the commissioner of the Food and Drug Ad-

ministration, has not ruled out emergency approval of a vaccine.

Maggie Haberman contributed re- SAMUEL CORUM FOR THE NEW YORK TIMES
porting, and Kitty Bennett contrib-
uted research.

January is ‘optimistic,’

but October has also

been mentioned.

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