EU says COVID boosters may have higher legal risks without EMA approval

Booster

26/08/2021 11:29

By Francesco Guarascio
    BRUSSELS, Aug 26 (Reuters) - European Union countries that
decide to use COVID-19 vaccine booster shots may face increased
legal risks because the additional dose has not yet been
recommended by the EU drugs regulator, the European Commission
said on Thursday.
    The European Medicines Agency (EMA) has repeatedly said that
more data is needed before it can approve the use of boosters,
but 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
authorisation 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 on
Thursday.
    "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 authorisation, companies' liability is
modified."
    This could mean that in the event of unexpected side effects
that can be linked to boosters, EU states might bear the brunt
of any legal consequences and compensation demands.
    The Commission said however that companies' liability would
not disappear entirely if boosters are administered without the
EMA's approval. For instance, if a side effect after a booster
is caused by manufacturing issues, the vaccine maker would
remain liable for it.
    EU liability and indemnity rules apply in cases of
unexpected adverse effects linked to the general characteristics
of the product or its manufacturing. Each company supplying
COVID-19 vaccines to the EU has negotiated different clauses,
which remain largely confidential.
    The European Centre for Disease Prevention and Control
(ECDC) said that Austria, Belgium, France, Hungary,
Liechtenstein, Lithuania, Luxembourg and Slovenia are currently
recommending the use of boosters, with Germany planning to do
the same in the autumn. Thirteen other European states are
discussing the matter. 
    In recent months, the EU has reserved billions of doses from
several COVID-19 vaccine makers for the coming years, saying
they may be needed for boosters or to fight new variants. They
could also be donated to poorer nations.
    COVID-19 booster shots will be made widely available to
Americans from Sept. 20, U.S. health officials said last week,
citing data showing diminishing protection from the initial
vaccinations as infections rise from the Delta variant
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    Possible compensation for unexpected side effects from
COVID-19 vaccines is managed at national level.
    Some EU countries, including the largest ones, have
compensation schemes that are meant to indemnify potential
victims outside courts, but criteria for reimbursements vary
greatly. In others, alleged victims would need to go directly to
courts to settle their case.
    Since the beginning of the vaccination campaign in Europe,
hundreds of claims have been submitted to authorities by
potential victims, official data from Denmark, Germany, Norway
and Switzerland show, with only a handful of compensation awards
so far granted, for undisclosed amounts of money.

 (Reporting by Francesco Guarascio @fraguarascio
Additional reporting by Stine Jacobsen in Copenhagen, Gwladys
Fouche in Oslo, Michael Shields in Zurich, Caroline Copley in
Berlin
Editing by Keith Weir and Frances Kerry)
 ((Francesco.Guarascio@thomsonreuters.com;))