september14–27, 2020| newyork 19This public distrust has likely been
fueled by continued hints from the presi-
dent that a vaccine might be available
before Election Day—a timeline most
experts believe is unfeasible without a short
circuit of the normal vetting process. That
could include authorizing a vaccine before
Phase 3 clinical trials are complete or mar-
ginalizing the input of the FDA’s indepen-
dent vaccine advisory committee. While
the Centers for Disease Control and Pre-
vention recently notified state and local
health officials to be prepared to distribute
potential vaccines as soon as late October,
as the New York Times reported, many
public-health experts are skeptical about
what even the CDC has labeled a “hypo-
thetical” scenario. “It would be surprising if
we had statistically robust evidence for this
vaccine working by the end of October,”
says Paul Offit, a vaccine expert at the Uni-
versity of Pennsylvania School of Medicine
and a member of the FDA advisory panel.
In a 1976 episode illustrating the dangers
of a rushed vaccine, a Gallup poll reported
that only 52 percent of Americans intended
to get a hastily prepared swine-flu vaccine,
and the government’s immunization pro-
gram was suspended within months of its
launch because of rare side effects perceived
to be associated with the shot.
Today’s resistance isn’t even limited to
anti-vaxxers or laypeople worrying about
side effects. The concern is so great that
some clinicians are already talking about
not administering a vaccine when it
becomes available if they believe the
approval process was rushed. That friction
is what led nine pharmaceutical companies
involved in the vaccine race to make a rare
public pledge last week not to cut corners.
Of course, beyond the question of when a
vaccine will be released is the question of
who will get it first. In July, the National
Academies of Sciences, Engineering, and
Medicine announced the formation of a
new expert panel to make recommenda-
tions on a scheme for rolling out a covid-19
vaccine with an initially limited supply. In
the midst of a viral invasion that has claimed
nearly 192,000 American lives, cost trillions
of dollars, and wagered billions more in tax-
payers’ money on a corporate horse race to
produce a vaccine, the announcement of
this panel should have been welcome news.
The problem, however, was that a separate
group, the Advisory Committee on Immu-
nization Practices (ACIP), already exists
and has advised the CDC on vaccine usage
in the U.S. since 1964.
Overlapping recommendations from two
obscure panels may seem like a bureaucratic
footnote to a historic national calamity. But
the redundancy is emblematic of how, six
months into the pandemic, the federal gov-
ernment manages, almost effortlessly, to
sow confusion and undermine faith in
public-health institutions at every turn.
Normally, the FDA is tasked with ensur-
ing vaccines are safe and effective prior to
licensure, and it also has the option to allow
one to be distributed under an Emergency
Use Authorization. The CDC then publishes
guidelines for who should get that vaccine,
usually following the recommendations of
ACIP, whose membership is appointed by
the Department of Health and Human Ser-
vices. But the National Academies assem-
bled its panel in response to a request from
Francis Collins, director of the National
Institutes of Health, and Robert Redfield,
director of the CDC—both members of the
White House Coronavirus Task Force. Red-
field’s participation in particular has mysti-
fied the infectious-disease community,
given that the new panel effectively compli-
cates the processes put in place at his own
agency and seemingly diminishes the CDC’s
independence. Another potential worry is
that the Washington-based panel might
become one more target in a larger cam-
paign of politicization. “This administration
has been willing to throw science-based
federal agencies under the bus, whether it’s
EPA, the National Weather Service, now the
FDA,” says Offit, “or to at least exert pressure
on them to do things the administration
wants, even if it goes against the science.”
The National Academies’ draft allocation
plan was released early this month and,
despite the fears, has won praise in initial
reviews. It envisions four phases. A “jump-
start” (Phase 1a) would give priority to high-
risk workers in health-care facilities and first
responders. Phase 1b would include people
with co-morbid conditions that put them at
significantly higher risk and older adults liv-
ing in congregate settings such as nursing
homes. Phase 2 would add workers in
industries that are “essential to the function-ing of society,” along with teachers, school
staff, people at “moderately higher risk,”
incarcerated people, and those living in
homeless shelters. Phase 3 would include
children, young adults, and other workers in
essential industries. Phase 4 would cover
“everyone residing in the United States’’ who
had not previously received the vaccine.
Yet six days before the National Acade-
mies’ plan came out, the CDC had already
sent a planning document to public-health
officials identifying its own prioritized
populations, and both plans are beset by
uncertainty. The National Academies out-
lined a scenario based on doses for 10 mil-
lion to 15 million people; the CDC’s “hypo-
thetical” scenarios envisioned 1 million to
3 million doses by the end of October, 10 to
30 million doses by the end of November,
and 15 million to 45 million doses by the
end of the year.
And the sheer logistics of vaccine distri-
bution will be daunting. The Pfizer vaccine
in advanced trials, for example, would need
to be stored at minus-70 degrees Celsius
prior to use. Only large, primarily academic
medical centers and health departments
have freezers with that capacity, effectively
ruling out traditional vaccination sites like
pharmacies and doctors’ offices. “This is a
very complicated vaccine program,” says
Luciana Borio, former acting chief scientist
at the FDA. “You have multiple vaccines, dif-
ferent technologies, staggered availability,
uncertainties. That on top of vaccine hesi-
tancy. It’s going to be very messy.”
That mess would be complicated by the
perception of corner-cutting. The FDA has
already come under criticism for issuing
Emergency Use Authorizations for contro-
versial treatments like hydroxychloro-
quine and convalescent plasma; an EUA
for a covid-19 vaccine would be met with
considerable skepticism. “If a decision
were made to use the vaccine that short-
circuited the FDA’s advisory committee,”
says William Schaffner, an infectious-
disease expert at Vanderbilt University
School of Medicine, “you would lose much
of the support of the clinical community
and the public-health community. There
would be prominent people who would
stand up and say, ‘Wait a minute. We’re
going to wait because you haven’t gone
through the right process.’ ”
Offit also raises an unexpected worst-case
scenario in addition to those that the public
and health officials have been mulling: “To
me, the irony—the ultimate irony—would
be if a vaccine works and then Donald
Trump stands up and oversells it, as he over-
sells everything, and people don’t want to
get it because they don’t trust him, because
he’s not trustworthy.” ■“ You have multiplevaccines, differenttechnologies,staggered availability,uncertainties.It’sgoingtobe very messy.”