HEALTH
B2 — THE OBSERVER & BAKER CITY HERALD
SATURDAY, JULY 31, 2021
Why hasn’t FDA given full approval for COVID vaccines?
career civil servants,
accustomed to carrying out
their careful reviews in rel-
ative obscurity, are under
public pressure like never
before.
By TOM AVRIL
The Philadelphia Inquirer
More than eight months
ago, large studies found that
both the Pfi zer-BioNTech
and Moderna COVID-19
vaccines reduced the risk
of illness by more than
90%. Yet the U.S. Food and
Drug Administration has
not yet granted them full
approval, to the dismay of
public-health offi cials eager
to boost vaccination rates
as the delta variant sends
infections skyward.
What is emergency
use?
Brad Horrigan/The Hartford Courant-TNS
Doses of the Moderna COVID-19 vaccine.
So what is
the holdup?
Part of the reason,
according to experts in
drug regulation, may be
simply that the agency can
aff ord to take the time.
In December, the FDA
authorized the fi rst two
vaccines for emergency
use, and did so for a third
in February. Those autho-
rizations, though based
on extensive, rigorous
research, are temporary
in nature. Before granting
permanent approval
(“licensure”), the agency
can spend months to make
triply sure that all regula-
tory requirements are met,
given that the vaccines are
available for all who want
them in the meantime.
Still, with the emer-
gence of the highly trans-
missible delta variant of
the coronavirus, pub-
lic-health offi cials are
eager for the agency to
move forward, contending
that full approval may pave
the way for more people to
be vaccinated.
That could happen in
two ways. Physicians hope
that if the agency licenses
the drugs, some who are
hesitant about vaccination
may become more recep-
tive. Even if not, more
businesses and institu-
tions may decide they have
a legal basis for requiring
the shots, said Greer
Donley, an assistant pro-
fessor at the University of
Pittsburgh Law School.
Hundreds of univer-
sities already have insti-
tuted vaccine mandates
for students enrolling this
fall, in one case surviving
a challenge in federal
court. And on Monday, the
U.S. Department of Vet-
erans Aff airs announced
it would require the shots
for 115,000 frontline med-
ical workers. But with
full approval, Donley
said, employers seeking
to require the vaccines
may feel they are on even
fi rmer legal ground.
Either way, FDA’s
The FDA’s power to
authorize drugs for emer-
gency use is relatively
new, enacted by Congress
in 2004 in response to the
anthrax attacks of 2001.
The agency can grant
such an approval if it is
“reasonable to believe”
that the product may
be eff ective, and that
its “known and poten-
tial benefi ts” exceed its
“known and potential
risks,” according to the
statute.
But vaccines are not
like most drugs, in that
they are administered
to healthy people to pre-
vent illness, not to treat it.
So when the FDA issued
guidance on what it would
require before autho-
rizing vaccines against
COVID-19, the agency
went beyond the letter of
the law.
Drug makers learned
they would need to enroll
tens of thousands of partic-
ipants, randomly assigning
some to receive the vac-
cine and others to get a
placebo. In short, they
needed to run the type of
large, well controlled trial
that is required for reg-
ular approval of any vac-
cine, said biostatistician
Susan S. Ellenberg, a pro-
fessor emerita at the Uni-
versity of Pennsylva-
nia’s Perelman School of
Medicine.
On Nov. 9, the partner-
ship of Pfi zer and BioN-
Tech announced that its
vaccine prevented more
than 90% of cases of
COVID-19, far exceeding
most expectations.
Similar results came a
week later from Moderna
Inc., and by the middle of
December, the FDA had
authorized emergency use
of both.
What more do they
need?
Before granting the
emergency authorizations,
the FDA analyzed the rates
of any side eff ects for two
months following adminis-
tration of the vaccines.
Any side eff ects caused
by vaccines tend to arise
within a month, and phy-
sicians generally agreed
that two months’ of safety
data was more than suffi -
cient — especially given
the urgency of curbing the
pandemic during the win-
tertime surge.
The evidence on the
COVID-19 vaccines was
promising, with some par-
ticipants reporting tempo-
rary consequences such as
a fever, headache, or sore
arm — nothing serious or
long-lasting.
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