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Image header Agence Europe
Europe Daily Bulletin No. 12979
Contents Publication in full By article 25 / 28
NEWS BRIEFS / Health

EMA recommends authorisation of Valneva’s Covid-19 vaccine

24/06/2022 (Agence Europe) – The European Medicines Agency (EMA) recommended, on Thursday 23 June, a conditional marketing authorisation for the SARS-CoV-2 vaccine developed by the firm Valneva. This developed inactivated whole virus vaccine is the sixth vaccine recommended by the EMA. The vaccine is currently recommended for adults between the ages of 18 and 50. The EMA states that the vaccine dossier contains the results of an immunobridging trial. Placebo-controlled efficacy trials have previously been the gold standard for authorisation of SARS-CoV-2 vaccines, but the EMA considers that the trial was well designed and that there are sufficient authorised vaccines now to provide a comparison. The EMA states that it is also becoming difficult to recruit unvaccinated or patients who have not been exposed to SARS-CoV-2 in numbers relevant for clinical trials. (EV)

Contents

EUROPEAN COUNCIL
ENERGY/ECONOMY: European Commission invited to draw up, by July, an emergency plan to reduce energy demand
EUROZONE: euro area leaders advocate coordination and agility to cope with economic uncertainty
FOOD SECURITY: EU leaders determined to step up efforts to get grain out of Ukraine and help most vulnerable countries
FUTURE OF EU: “broad consensus” among EU Member State leaders on idea of a ‘European Political Community’
FUTURE OF EU: as a follow-up to Conference on Future of Europe, European Council sticks to bare minimum
TAXATION: Franco-Hungarian discussion on minimum taxation of multinationals
EXTERNAL ACTION
ENLARGEMENT: Bulgarian Parliament votes in favour of lifting veto on North Macedonia’s accession to EU
IRAN: Borrell in country to discuss nuclear agreement
TRADE: Europe Jacques Delors criticises export rebates for companies affected by Carbon Border Adjustment Mechanism
SECTORAL POLICIES
ENERGY: revision of Energy Charter Treaty, contracting parties conclude an agreement in principle
ENERGY: EU energy situation, rising prices and ‘Fit for 55’ package on agenda of meeting of EU energy ministers
INTERNAL MARKET: EU Member States decide on their position on machinery and equipment regulation
SEA: European Commission adopts new EU programme on international ocean governance
FISHERIES: European Commission endorses €42.8 million Czech programme under EMFAF
AGRICULTURE: EU registers 11 new geographical indications from Central America
DIGITAL: Joint Research Centre report examines link between artificial intelligence and children’s rights
Russian invasion of Ukraine
ENVIRONMENT/CLIMATE: Ukraine joins EU’s LIFE programme, which will be able to co-finance environmental restoration projects
FUNDAMENTAL RIGHTS - SOCIETAL ISSUES
DEMOCRACY: transparency on online political advertising, Sandro Gozi’s report ready for debate in European Parliament committee
EUROPEAN PARLIAMENT PLENARY
SUSTAINABLE DEVELOPMENT: European Parliament wants EU to have a strategy and a special envoy for implementation of UN SDGs
JUSTICE: European Parliament calls for extension of mandate of European Public Prosecutor’s Office to include a “Green Prosecutor”
NEWS BRIEFS
HUMANITARIAN AID: EU mobilises €2 million in emergency aid for flood victims in Bangladesh and India
COHESION: European Commission adopts partnership agreement with Netherlands to promote energy transition investments
TRADE: world services trade expected to rise in second quarter of 2022, according to WTO forecasts
HEALTH: ‘serious cross-border health threats’ regulation, likely approval of provisional agreement on 29 June in EU Council
HEALTH: EMA recommends authorisation of Valneva’s Covid-19 vaccine
TRANSPORT: European Commission consults on extending aid to airports with less than 3 million passengers per year
TRANSPORT: European Commission launches Alliance for Zero Emission Aviation
UKRAINE: Russia thinks granting candidate status to Ukraine is an “internal European matter”