December Issue III

news 5
Graphics and design by Anna Wang ‘22
how to rush a panacea
The Controversy of Emergency Use Authorization of the COVID-19 Vaccine
By GWYNETH CONGER ‘23
A quantity of 218 nationally recognized regions
affected.
An approximate sum of 63,000,000 contracted
cases.
An estimated total of 1,460,000 deaths.
A single vaccine– the Pfizer-BioNTech COVID-19.
It’s been roughly a year since the initial
discovery of the dreaded virus
in December 2019, when the original
fledglings of worry grew into the
global state of panic that we know so well.
This is excellent news in many ways.
Serious credit and gratitude are wholly due
to the scores of scientists who risked their
own health to provide us with a solution.
However,
as all
of the vaccines
are
currently
coming in
through
emergency
protocol
alone
(meani
n g
none
of the
aforem
e n -
tioned immunizations have been
fully approved), their appearance has instigated
a surprising public controversy.
Weren’t there rumors about it being done
earlier? Or was it rushed out early and incomplete?
Is it early, or is it late? Is it even
approved in the first place? Questions such
as these are quickly becoming a worrying
sight on newsfeeds and online communities.
Here, we’ll be looking at the Authorization
that will bring all of the current
vaccines to millions of citizens,
rather than the s u b -
stance of the
solutions
themselves,
and
the internal
conflicts and inquiries
that have
followed.
EMERGENCY USE
AUTHORIZED
What do you know
about the Emergency
Use Authorization?
A relatively recent sanctioned authority
of the FDA, the Emergency Use
Authorization (EUA for short) was legalized
in 2004 and first utilized in 2009.
Comparable to a System Bypass program,
it’s used only in severe cases to push
actions through the FDA when waiting
is no longer sensible or available. It was
first used during an outbreak of the H1N1
influenza pandemic in 2009. It passed a
Real-time RT-PCR Detection and Characterization
Panel (a testing system for
the virus), but only due to the lack of a
better option– an idea that encapsulates
most of the controversy surrounding it.
On October 22, 2020,
the FDA met to discuss
the EUA and licensure
regarding t h e
COVID-19
vaccine.
check-
Consistently
titling it
a “pre-election
box” (a clear ex-
aggeration as the cure ultimately failed to
meet its due date), President Trump rapidly
took strides to push it through by continuously
stamping approvals until the EUA
was officially authorized for this matter.
So what’s the problem with this?
Whenever the EUA is concerned, the lives
of people are at stake. Whether or not it’s
endorsed depends on if the potential risks
of haste outweigh the potential risks of
time-tested quality. To date, there remains
only one other instance when the FDA received
approval for an emergency vaccine,
and even that was just barely authorized.
This situation initially appears to
pose little difference, for even though the
EUA is an “emergency response,” there
remain inviolable protocols to be bypassed,
regardless of the level of necessity.
So, what now? As seniors and healthcare
workers will be the first subjects of
the injection, Baldwin students will have
to wait a little while for a vaccination,
possibly as late as this spring. Even then,
a vaccine needs to
operate
on a
50%
accuracy
to go
through
an EUA
(FDA),
so side
effects
a n d
technicalities
may still
need attention
even after it is released to those
over 16 within Bryn Mawr. At that point,
it will be up to the public to decide between
the two options and where the pros
surpass the cons. What will you choose?
Leading
vaccines in
the world
BACKGROUND INFO ON THE
FOUR LEADING COVID-19
VACCINES AS REPORTED BY
THE NEW YORK TIMES
NAME:
BNT162b2
DEVELOPER:
Pfizer-BioNTech
TYPE:
mRNA
STATUS:
Approved in UK,
Bahrain, Canada,
Mexico, US
NAME:
mRNA-1273
DEVELOPER:
Moderna
TYPE:
mRNA
STATUS:
under FDA review
NAME:
Ad5-nCoV
DEVELOPER:
CanSino
TYPE:
Adenovirus
STATUS:
Limited use in
China
NAME:
Sputnik V
DEVELOPER:
Gamaleya
TYPE:
Adenovirus
STATUS:
Early use in Russia