COVID-19 Vaccine Makers Expect EU Liability Shield for Unexpected Side-Effects

By | September 22, 2020

Vaccine makers will be indemnified in Europe if their COVID-19 shots cause unexpected side-effects, an industry official said on Tuesday, as nearly 40 firms pursue talks on possible authorisation for shots in development.

The European Commission has confidential liability clauses in contracts signed with AstraZeneca and Sanofi 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 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.

Middleton 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.

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

ROLLING REVIEW

No COVID-19 vaccine has yet been authorized 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 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 authorized 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 authorize vaccines before they can be used in the EU.

(Reporting by Francesco Guarascio; Editing by Gareth Jones, Jason Neely and Alexander Smith)

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