The COVID-19 Vaccine Race: With Risks Come Rewards

• Author: Daniel S. Wittenberg
• Pages: 26-27

Published in Litigation News Volume 46, Number 1, Fall 2020. © 2 020 by the American Bar A ssociation. Repro duced with permissi on. All rights reser ved. This informati on or any portion the reof may not be copie d or disseminated in any form

or by any means or stored i n an electronic database o r retrieval syst em without the expr ess written co nsent of the American B ar Association.

harmaceutica l and biotech companies a re work-

ing diligently to develop C OVID-19 thera-

pies. Currently, however, the Food and Dr ug

Administ ration (FDA) has not approved any to treat

the virus. I n the meantime, countries arou nd the

globe are looking to lo ck up vaccines even before the y are

ready. In late July, the White House an nounced a nearly $2

billion contract w ith Pzer a nd BioNTech for 100 million

doses by December. Be fore that, Astra Zeneca annou nced

a $1.2 billion deal wit h the U.S. govern ment. AstraZ eneca

also recently an nounced a deal to supply up to 400 m illion

doses to Europe’s Inclusive Vaccine A lliance, spe arheaded

by Germany, France, Ita ly, and the Netherlands. Swede n

later joined the group by in king its own $229 m illion deal.

The U.S. govern ment’s agreements with t hese and other

companies are par t of Operation Warp Speed (OWS). OWS

aims to deliver 300 m illion doses of vaccine for COVID -

19 by January 2021 and is pa rt of a broader strategy to

accelerate development, ma nufacturin g, and distribution

of pandemic counterm easures with f unding of $10 bil-

lion approved by Congress. To incentivi ze rapid devel-

opment efforts and a key fe ature of many of the supply

agreements, compa nies are being g ranted protection from

future product liability claims.

Immunity from Tort Liability

In support of OWS’s mission and to encour age the life sci-

ence sector to under take accelerated produc t development,

the Depart ment of Health and Hum an Service s (HHS)

bestowed extensive im munity on vaccine and therapy

makers for development-related act ivities. Pur suant to the

Public Readine ss and Emergency P reparedness Ac t (PREP

Act), the HHS issue d a notice of declaration con ferring

immunity f rom tort litigation for thos e developing vac-

cines or medici nes against COV ID-19. Though risk always

exists in developing a ny new therapy, particula rly on an

expedited basis , the benets of creat ing a countermeas ure

likely outweigh the r isk of adverse events associ ated with

such therapy.

The PREP Ac t authorizes the H HS secretary to issue a

declaration to provide liabi lity immunity to certa in individu-

als and entities aga inst any claim of loss caused by, arising

out of, relating to, or resulti ng from the manufacture, dis tri-

bution, admini stration, or use of medical counterme asures

(Covered Countermeasu res), except for claims involvi ng

“death or serious physical injur y proximately caused by w ill-

ful misconduc t” as dened in the PREP Act .

Under the PREP Ac t, willful misconduc t is an act or omis-

sion (1) “intentionally to achieve a wrongf ul purpose,” (2)

The COVID-19 Vaccine Race:

With Risks Come Rewards

By Daniel S. Witte nberg, Litigation N ews Associate Editor

© Getty Image s

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BUSINESS OF LAW