EU Says Without EMA Approval COVID-19 Boosters May Face Higher Legal Risks: Reuters - AstraZeneca (NASDAQ:AZN), BioNTech (NASDAQ:BNTX)

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