EU countries may face increased legal risks if they decide to use booster shots of COVID-19 vaccines, the European Commission has told the Reuters news agency.

This is because the additional dose has not yet been recommended by the EU drugs regulator, the European Medicines Agency (EMA). The watchdog has said that more information is needed before it can back the use of booster shots.

Reuters says that eight European countries have decided to recommend the additional dose, and more than a dozen are set to make similar moves shortly.

Firms’ liability ‘modified’

“The responsibility to decide to include boosters in their vaccination campaign remains with the member states,” the commission said in a statement to the news agency.

“As long as the booster doses are not part of the marketing authorisation, companies’ liability is modified,” the EU body added.

This could mean that, in the event of unexpected side-effects that could be linked to boosters, EU states might bear the brunt of any legal consequences and compensation demands.

The commission stressed, however, that companies’ liability would not disappear entirely if boosters were administered without the EMA’s approval. For instance, if a side-effect after a booster was caused by manufacturing issues, the vaccine maker would remain liable for it.