![handle is hein.journals/bothnl40 and id is 1 raw text is: News Briefs
40 Biotechnology Law Report 1
Number 1, 2021
© Mary Ann Liebert, Inc.
DOI: 10.1089/b1r.2020.29216.sjz
Selected Developments in Biotechnology Law
and the Biotechnology Industry
By STEVEN J. ZWEIG
SECOND RNA-BASED COVID-19 VACCINE
APPROVED BY U.S. REGULATORS
Only a week after emergency use authorization
was granted for the Pfizer/BioNTech RNA-based
COVID-19 vaccine,' the U.S. Food and Drug
Administration (FDA) approved a second such vac-
cine on December 17, 2020: Moderna's vaccine,
which was created in collaboration with the U.S
National Institute of Allergy and Infectious Dis-
eases (NIAID).2 Having two vaccines available for
use so quickly is an unprecedented accomplishment
and shows the power and value of biotechnology.
As immunologist James Hildreth, the president of
Nashville, Tennessee's Meharry Medical College,
put it, [t]o go from having a [gene] sequence of a
virus in January to having two vaccines available
in December is a remarkable achievement.
Equally as impressive in its own way as the rapid
development of the vaccines is the rapid approval, at
least on an emergency use basis: for anyone used
to working with government regulators, approval
of new vaccines in less than a year fully lives up
to the promise of the name Operation Warp
Speed since it-in comparison with the usual re-
view and approval process-took place at faster-
than-light velocity. And also impressive is that not
only are the vaccines approved, but they are avail-
able and have already begun being deployed: as of
Steven J. Zweig is the Managing Editor of Biotechnology
Law Report.
writing, several hundred thousand Americans have
already been inoculated and millions of doses are
expected to become available each week going for-
ward in a tour de force of manufacturing and lo-
gistics. The COVID-19 vaccine development and
deployment represent collaboration between indus-
try and government on a scale not seen in this na-
tion since World War II. After we get through the
current pandemic, perhaps this effort can serve as
a template for expeditiously harnessing biotech to
address other or future issues and threats.
The U.S. is not the only nation that has approved
vaccines for emergency usage: the United Kingdom
has also begun inoculations.
Both Pfizer's and Moderna's vaccines consist of
RNA encased in a lipid nanoparticle delivery sys-
tem. The RNA induces recipients' cells to produce a
SARS-CoV-2 protein known as the spike, which
then triggers an immune defense. The two vaccines
differ primarily in their lipids, which makes for
an important practical difference: the Pfizer vaccine
needs to be stored at -70 degrees Celsius, which is
far colder than most freezers can go, limiting the fa-
cilities which can handle it. The Moderna vaccine,
on the other hand, requires only -20 degrees Celsius,
which while still very cold, is with the reach of
many more medical freezers-and it can even be
stored in a commonly available refrigerator at -4
degrees Celsius for up to 30 days.
'Not surprisingly, most biotechnology-related news at this
time remains COVID-related.
2Dr. Anthony Fauci is the Medical Director of NIAID.
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