The countries of the European Union that decide to grant booster doses vaccines against coronavirus may face increased legal risks because an additional dose is not yet recommended by the EU drug regulator, the European Commission announced on Thursday.
According to Reuters, the European Medicines Agency (EMA) has repeatedly stated that more details before approving booster doses.
However, eight European countries decided to recommend the additional dose and more than twelve similar decisions are expected soon.
“The commemorative doses not are currently included in the marketing authorization of Covid-19 vaccines and have not yet been scientifically evaluated by the EMA due to the lack of sufficient data, “the European Commission said in a statement.
“The responsibility to decide to include booster doses in their vaccination campaign lies with the Member StatesThe announcement points out and adds: “Since the booster installments are not currently included in the vaccine marketing authorization, the companies’ liability is modified”.
This may mean that in case unexpected side effects which may be linked to booster doses, EU Member States may carry the weight any legal consequences and claims for compensation.
The Commission states, however, that the responsibility of companies it will not disappear completely if booster doses are given without EMA approval. For example, if a side effect after the booster dose of the vaccine is caused by an issue Friday, then the pharmaceutical industry will remain responsible for it.
EU liability and compensation rules apply in cases of unexpected side effects related to the general characteristics of the product or their manufacture. Every company that supplies Covid-19 vaccines in the EU has negotiated different clauses which remain largely confidential, concludes the relevant Reuters article.
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