Europe Indemnifies COVID-19 Vaccine Makers in Case of Side Effects

The European Commission’s (EC) contracts with COVID-19 vaccine suppliers include limited indemnity against liability in case of unexpected side effects, the president of a European vaccine trade group said this week.

Sue Middleton, president of the executive board of Vaccines Europe, said in a European Parliament hearing that, under the advance purchase agreements in place, the commission or EU member states would “essentially indemnify the companies against the cost of legal action” arising from claims of adverse events.

Although vaccines may cause certain known side effects, unexpected side effects of vaccines are relatively rare, Middleton said. However, she noted that some did occur in previous mass vaccination campaigns, such as for measles, mumps and rubella.

Companies would still be liable if they engage in “willful misconduct” or violations of good manufacturing practices that cause harm, she said.

A commission spokesperson acknowledged that EC agreements with vaccine suppliers provide for EU “member states to indemnify the manufacturer of certain liabilities incurred under specific and strict conditions,” but she declined to elaborate what those conditions are. She did add that all other legal liability “still remains with the companies.”

The commission has secured COVID-19 supply agreements with Sanofi and GlaxoSmithKline for 300 million doses of their vaccine, as well as with AstraZeneca for up to 400 million doses of its vaccine. It is negotiating separate supply deals with Johnson & Johnson, CureVac, Moderna and Pfizer/BioNTech (DID, Sept. 21).

The U.S. has adopted a similar approach to liability for COVID-19 products. In March, HHS announced that it was providing immunity from legal liability, except in cases of “willful misconduct,” for any drug, biologic, device or vaccine approved or cleared to treat, diagnose, cure, prevent or mitigate COVID-19 (DID, March 13). — Jordan Williams