European Union countries, which decide to use booster doses of vaccines against Covid-19, may face increased legal risks because the European Medicines Agency has not yet recommended an additional dose, the Commission announced today.
The European Medicines Agency (EMA) has repeatedly said it needs more data before it can approve the use of booster doses, but eight European countries have decided to recommend the additional dose and another 13 are preparing to take similar action soon.
"At the moment, booster doses are not included in the approval of the distribution of vaccines against it Covid-19 "They have not yet been scientifically evaluated by the EMA, as there is insufficient data," the commission said in a statement to Reuters today.
"Responsibility for the decision to include aid installments in their vaccination campaigns remains with the Member States," the statement said, adding: "Unless approval has been given for the placing on the market of aid installments, the companies' legal liability is changed."
This may mean that in the event of unintended side effects, which may be linked to aid installments, EU Member States may be fully responsible for any legal consequences and claims for damages.
The Commission states, however, that the companies' legal liability does not disappear completely if the aid installments are granted without the approval of the EMA. For example, if a booster side effect is caused by issues related to vaccine preparation, the vaccine manufacturer still has legal liability.
The European Center for Disease Prevention and Control (ECDC) has announced that Austria, Belgium, France, Hungary, Liechtenstein, Lithuania, Luxembourg and Slovenia are currently recommending the use of booster doses, while Germany plans to in the fall itself. Another 13 European countries are discussing the issue.