Benzinga | Aug 26, 2021 04:21PM EDT

EU Says Without EMA Approval COVID-19 Boosters May Face Higher Legal Risks: Reuters

* European Union countries that decide to use COVID-19 vaccine booster shots may face increased legal risks, the European Commission said.

* Related Content: Pfizer, BioNTech Seeking Full Approval For Third COVID-19 Vaccine Dose

* The European Medicines Agency (EMA) has repeatedly said that it requires additional data before approving the use of boosters.

* Eight European countries have decided to recommend the additional dose, and more than a dozen are set to make similar moves shortly.

* "Booster doses are currently not part of the marketing authorization of COVID-19 vaccines and have not yet been subject to a scientific assessment by EMA in the absence of sufficient data," the EU Commission said in a statement to Reuters.

* "The responsibility to decide to include boosters in their vaccination campaign remains with the Member States," the statement said, adding: "As long as the booster doses are not part of the marketing authorization, companies' liability is modified."

* However, the Commission said that companies' liability would not disappear if boosters are administered without the EMA's approval.

* Photo by Johaehn from Pixabay