Reconsidering Discretion in Expedited Vaccine Approval in Light of the Novel Coronavirus
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RECONSIDERING DISCRETION IN
EXPEDITED VACCINE APPROVAL IN
LIGHT OF THE NOVEL CORONAVIRUS
Daniel Joshua Ganz *
As the world continues to combat the COVID-19 pandemic and the
economies of many US cities and states remain largely closed, there is
growing evidence that the 2020 general election has put pressure on poli-
cymakers to rush the development and testing of a vaccine. The legal rules
on expedited development and review of vaccines provide substantial dis-
cretion to the Secretary of Health and Human Services, and this discretion
is at risk of being abused in an election year. I provide three proposals for
reducing the risks of abuses of discretion in the vaccine approval process.
Congress would be prudent to implement in some form one or more of these
proposals to ensure the integrity of US vaccine development and testing in
this and other election years.
I. INTRODUCTION
As the novel coronavirus continues to spread and wreak havoc throughout
the world, the international community has become focused on developing a vac-
cine for the virus. The United States has committed more than one billion dollars
to the development of a coronavirus vaccine,' and other countries are also work-
ing tirelessly towards a vaccine.2
As the economies of many US cities and states remain largely closed and
the 2020 election draws near, there is a real threat that it will pressure policy-
makers to rush the development and testing of a vaccine. The legal framework
surrounding vaccine testing and approval, which gives significant discretion to
the Secretary of Health and Human Services to expedite the development of a
* Daniel Ganz is a concurrent degree student at the University of California, Irvine. He is pursuing a JD
(expected May 2021) and a PhD in Economics (expected June 2022).
1. Antonio Regalado, Here's What We Have to Do to Show a Coronavirus Vaccine Works, MIT TECH.
REV. (May 26, 2020), https://www.technologyreview.com/2020/05/26/1002 19 1/how-show-a-coronavirus-vac-
cine-prevents-covid-19/ [https://perma.cc/94UZ-3NLQ].
2. Claire Felter, What Is the World Doing to Create a COVID-19 Vaccine?, COUNCIL ON FOREIGN
RELATIONS (Aug. 26, 2020), https://www.cfr.org/backgrounder/what-world-doing-create-covid-19-vaccine
[https://perma.cc/XCB5-AXC2].
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Reconsidering Discretion in Expedited Vaccine Approval in Light of the Novel Coronavirus
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