No-Fault Compensation for Vaccine Injury — The Other Side of Equitable Access to Covid-19 Vaccines

Type Journal Article Author Sam Halabi Author Andrew Heinrich Author Saad B. Omer URL https://www.nejm.org/doi/10.1056/NEJMp2030600 Rights Copyright © 2020 Massachusetts Medical Society. All rights reserved. Publication New England Journal of Medicine Date 28/10/2020 Loc. in Archive world Extra Publisher: Massachusetts Medical Society DOI 10.1056/NEJMp2030600 Library Catalog www.nejm.org Language en Abstract Perspective from The New England Journal of Medicine — No-Fault Compensation for Vaccine Injury — The Other Side of Equitable Access to Covid-19 Vaccines The Covid-19 pandemic has triggered a global vaccine race. As of September 27, 2020, there were more than 200 vaccine candidates in preclinical and clinical development, including 11 in phase 3 trials. Wealthy governments that have invested in vaccine candidates have made bilateral agreements with developers that could result in vaccine doses being reserved for the highest-income countries — a phenomenon known as “vaccine nationalism” — potentially leaving people in poor countries vulnerable to Covid-19. The response to vaccine nationalism has been the creation of the COVAX Facility, an international partnership that aims to financially support leading vaccine candidates and ensure access to vaccines for lower-income countries. Seventy-nine higher-income countries are COVAX members. Their governments will help support 92 countries that couldn’t otherwise afford Covid-19 vaccines. But large, up-front financial commitments to manufacturers are only half the solution when it comes to ensuring that companies will be willing to participate in the COVAX mechanism for vaccine distribution. Equally important is offering companies protection against potentially substantial liability should Covid-19 vaccines cause real or perceived injuries to recipients. Manufacturers won’t agree to procurement contracts or ship vaccine without liability protection. According to an AstraZeneca executive, for example, in the company’s bilateral contracts, it has been granted protection against legal claims arising from the use of its vaccine products, since it “cannot take the risk” of liability.1 As early as 2006, the International Federation of Pharmaceutical Manufacturers and Associations, the global pharmaceutical-industry lobbying group, publicly demanded that manufacturers be granted protection from lawsuits associated with vaccine-related adverse events if they were going to participate in pandemic responses. In the United States, the Public Readiness and Emergency Preparedness Act provides manufacturers immunity from lawsuits related to injuries caused by vaccines, with narrow exceptions. People injured by Covid-19 vaccines must file claims with a fund administered by the Department of Health and Human Services.