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COVID-19 vaccine makers see EU shield against side-effect claims

BRUSSELS (Reuters) - Vaccine makers will be indemnified in Europe if their COVID-19 shots cause unexpected side-effects, an industry official said on Tuesday, urging European regulators to set up more predictable schemes to compensate possible victims.

FILE PHOTO: A woman holds a small bottle labeled with a "Vaccine COVID-19" sticker and a medical syringe in this illustration taken April 10, 2020. REUTERS/Dado Ruvic/Illustration/File Photo/File Photo

The European Commission has confidential liability clauses in contracts signed with AstraZeneca AZN.L and Sanofi SASY.PA and is negotiating similar conditions with other firms for the advance purchase of their potential vaccines.

Sue Middleton, President of the Executive Board of Vaccines Europe which represents top vaccine makers, told a European Parliament hearing that in case of unexpected adverse events, which could include unpredicted side-effects, she understood that there was indemnification.

“The Commission or the member states would essentially indemnify the companies against the cost of legal action that followed those claims,” she said, adding that these events were rare and that she had not seen all contracts signed so far.

A spokesman for the European Commission declined to comment specifically on Middleton’s remarks, but said advance purchase deals “provide for member states to indemnify the manufacturer for certain liabilities incurred under specific and strict conditions” but “liability still remains with the companies”.

Officials have said partial legal protection offered by the EU hampered advance purchase deals in past months and prompted vaccine makers to ask for more.

Consumer organisations and lawmakers insist companies should be liable for all potential side-effects.

The comments come after Russia told Reuters it was so confident its vaccine was safe that it would shoulder the liability for anything going wrong, leaving the state-backed developers open to potentially costly compensation claims.

The United States also offer a full liability coverage to vaccine makers because widespread inoculation against disease is considered a benefit to society.

Middleton also called for no-fault compensation in all 27 EU states for COVID-19 vaccines which would speed up resolution of legal disputes. Such a system is in place in 11 countries, but its application to COVID-19 vaccine cases is not always clear, she said.


The no-fault system would reduce legal uncertainties and costs to companies.

These schemes also allow citizens to claim more quickly payments for injuries that followed vaccinations or treatments, but compensation is capped and is usually far below what can typically be awarded in a successful product liability lawsuit.

The World Health Organisation has made it clear to countries interested in joining its COVAX facility for vaccine purchases that pharmaceutical firms may ask for no-fault schemes. It has not committed to opposing them in negotiations with vaccine makers.

No COVID-19 vaccine has yet been authorised in Europe, with clinical trials underway. But contacts between vaccine makers and regulators are ongoing to speed up possible authorisations.

The World Health Organisation lists 38 candidate vaccines in late-stage trials, including those from China and Russia. Another 149 are in pre-clinical evaluation.

“As of early September the EMA has been in contact with developers of 38 potential COVID-19 vaccines,” Fergus Sweeney, head of clinical studies and manufacturing task force at the European Medicines Agency, told EU lawmakers.

Under a faster “rolling review”, vaccine makers can share data with EMA on their trials as they happen, so that shots could be authorised more quickly when all data is available.

No rolling review has yet began on vaccines, Sweeney said, adding the agency was expecting that to begin in the coming weeks. EMA must authorise vaccines before they can be used in the EU.

Reporting by Francesco Guarascio; additional reporting by Ludwig Burger; Editing by Gareth Jones, Jason Neely, Alexander Smith and Tomasz Janowski