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US News Coronavirus: The EU, under pressure, is considering authorization for emergency use of vaccines

19:12  02 march  2021
19:12  02 march  2021 Source:   rfi.fr

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HEALTH-CORONAVIRUS-EU-VACCINES: Coronavirus: The EU, under pressure, is considering authorization for the use of

CORONAVIRUS: L'UE, SOUS PRESSION, ENVISAGE L'AUTORISATION D'UTILISATION D'URGENCE DES VACCINS vaccine emergency © Reuters / LISI NIESNER CORONAVIRUS: EU, UNDER PRESSURE, CONSIDERS AUTHORIZATION FOR EMERGENCY USE OF

VACCINES by Francesco Guarascio

BRUSSELS (Reuters) - The European Commission announced on Tuesday that it is considering grant emergency use authorizations for upcoming COVID-19 vaccines as a faster alternative to the conditional marketing authorizations (MAs) in use today.

This decision would mark a turning point in the validation of vaccines because it would involve the use of a procedure that the European Union (EU) considers risky and which, before the COVID-19 pandemic, was exceptionally used at national level for treatments, especially anticancer drugs, terminal illnesses.

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This potential change would come as the European executive and the medicines authority are increasingly criticized for the slowness of vaccine authorizations, which has contributed to slowing the deployment of vaccines in the euro area compared to the situation in the United States and Great Britain.

"We are ready to reflect with Member States on all possible avenues to speed up validation of vaccines," a European Commission spokesperson told a press conference.

One option could be "an emergency vaccine authorization at EU level," the spokesperson said, adding that steps could start very soon if governments back the idea.

The Commission spokesperson told Reuters that he was not sure that an EU-wide emergency use authorization procedure would include the same criteria as those granted at EU level. national.

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The European Medicines Agency (EMA) cannot currently issue emergency authorizations but, in exceptional circumstances, it has already recommended the use of medicines for humanitarian purposes before a marketing authorization.

This procedure was used last April with remdesivir, Gilead's antiviral drug, which later received conditional Marketing Authorization.

CHANGE OF TRACK

Emergency use authorizations issued by a Member State are permitted for vaccines by European legislation but they oblige countries to take full responsibility in the event of a problem.

The European Commission had stated that it did not recommend such a procedure for COVID-19 vaccines because faster authorizations could reduce the ability of national authorities to verify efficacy and safety data on the one hand and reinforce anti-vaccine sentiments in some countries on the other hand.

A senior EU official said the emergency procedure has so far been generally used nationally for terminally ill patients and the EU has opted for conditional MA - with longer and longer monitoring stringent - because vaccines are "given to healthy people".

Several Eastern European countries, including Hungary, Slovakia and the Czech Republic, have approved Russian and Chinese vaccines following emergency procedures.

Britain has also used this type of procedure to approve COVID-19 vaccines.

(Francesco Guarascio, with Emilio Parodi, French version Laetitia Volga, edited by Jean-Michel Bélot)

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This is interesting!