COVID-19 vaccine makers are lobbying the European Union for protection against lawsuits, should problems arise with new therapies, the Financial Times reported Tuesday.
What Happened: Vaccines Europe, a division of the European Federation of Pharmaceutical Industries and Associations, which represents companies such as AstraZeneca plc (NYSE:AZN), GlaxoSmithKline plc (NYSE:GSK), Novavax, Inc (NASDAQ:NVAX), and Pfizer Inc (NYSE:PFE) are warning of “inevitable” risks, according to a circulated memo from the body, FT noted.
“The speed and scale of development and rollout do mean that it is impossible to generate the same amount of underlying evidence that normally would be available through extensive clinical trials and healthcare providers building experience,” the memo stated.
Vaccine Europe’s memo called for a “comprehensive no-fault and non-adversarial compensation system,” and also wants to be exempted from civil liability.
The EU denied that it was negotiating contracts with drugmakers where its Product Liability Directive rules would not be applicable, FT reported.
The regional bloc reportedly said it was making a provision for its member states to indemnify the vaccine makers for “certain liabilities” through advance purchase deals in light of “high risks taken by manufacturers.”
Why It Matters: Several vaccine candidates are already in late-stage human testing or nearing such tests, including those from Inovio Pharmaceuticals Inc (NASDAQ:INO), Moderna Inc (NASDAQ:MRNA), Pfizer, and Johnson and Johnson (NYSE:JNJ).
The memo issued by the group of vaccine makers says some people are likely to suffer “adverse events” post-vaccination and the scale of the vaccination may lead to “numerous damage claims,” FT reported.
In the United States, the liability of vaccine makers may be limited in case of products developed to control the public-health crisis due to the 2005 Public Readiness and Emergency Preparedness Act, according to Reuters.
AstraZeneca has reportedly already secured liability protection in most countries, although the company hasn't discloses any names.
The British drugmaker’s COVID-19 vaccine could be fast-tracked for approval in the United States ahead of the presidential elections in November.