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Law360 (September 22, 2020, 9:29 PM EDT) -- A pharmaceutical industry official told the European Commission on Tuesday that she believes that manufacturers of vaccines for the novel coronavirus would be legally protected if their products caused adverse side effects.
Sue Middleton of industry group Vaccines Europe said that, as she understands it, people who have adverse reactions to a vaccine would be compensated through a no-fault compensation scheme, as she urged the lawmakers to address the issue further. While unexpected adverse reactions from vaccines are rare, Middleton said, it is possible they could occur when vaccinating such a large population.
"The Commission or the member states would essentially indemnify the companies against the cost of legal action that followed those claims," she said during a livestreamed hearing.
The no-fault compensation scheme would enable patients to be quickly compensated for their injuries, Middleton said. There are no-fault compensation schemes in 11 European Union countries, although it can be hard to tell how the schemes apply to COVID-19, she said. The pharmaceutical industry official also urged that all 27 EU countries should have no-fault compensation schemes.
According to Middleton, eight billion COVID-19 vaccine doses are needed to vaccinate half of the world's population. The annual global production of vaccines is five billion doses, she said.
Middleton also said that a price between €5 to €15 per dose, or $5.85 to $17.56, would be appropriate.
As of Tuesday, nearly 200,000 people had died due to COVID-19 in the U.S., according to the Centers for Disease Control and Prevention. Globally, more than 967,000 have died, according to the Johns Hopkins University's case tracker.
The EU has signed contracts with AstraZeneca and Sanofi to buy COVID-19 vaccines once they are developed and is working on contracts with other companies.
Clinical trials for AstraZeneca's vaccine recently restarted after a report of an unexplained illness occurred in its phase 3 trial in the United Kingdom.
Three companies in phase 3 trials for a vaccine have publicly shared their study protocols so that others can study them, which is "very, very unusual," Middleton said.
In the U.S., medical products and drugs are protected from liability for adverse events under the PREP Act of 2005, which shields companies from liability for products developed to counteract a public emergency.
In the early days of the pandemic, President Donald Trump signed off on the Families First Coronavirus Response Act, or H.R. 6201. A provision of the law expands liability protections for manufacturers of N95 face masks — which are designed to filter out 95% of airborne particles — under the PREP Act of 2005 for emergency use during the pandemic. Those protections will expire Oct. 21, 2024.
Face masks approved by the U.S. Food and Drug Administration have additional splash protection and were already immune from liability claims under the PREP Act. However, the ones that are approved by just the National Institute for Occupational Safety and Health were not. The latter type comprises the bulk of the face masks on the market and is also used in medical settings.
--Editing by Nicole Bleier.
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