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Image header Agence Europe
Europe Daily Bulletin No. 12956
Contents Publication in full By article 23 / 40
EU RESPONSE TO COVID-19 / Health

EMA begins formal evaluation of Valneva’s SARS-CoV-2 vaccine and is considering authorisation of Pfizer-BioNTech booster dose for children

The Committee for Medicinal Products for Human Use of the European Medicines Agency (EMA) began, on Wednesday 18 May, the formal scientific evaluation phase of the SARS-CoV vaccine developed by the firm Valneva, VLA200. The company was able to apply for a conditional marketing authorisation for its vaccine for adults aged 18 to 55.

This inactivated, adjuvanted whole virus Covid-19 vaccine, developed by Valneva, has been undergoing a progressive evaluation since 2 December 2021 (see EUROPE 12909/25).

This conditional authorisation procedure makes it possible to speed up the placing on the European market of promising medicines in the event of a public health emergency for a renewable period of one year.

It is up to the European Commission to issue the conditional authorisation, if necessary, if the EMA’s recommendation proves positive.

The EMA’s Committee for Medicinal Products for Human Use began, on Monday 16 May, an evaluation of a booster dose of Comirnaty, the messenger RNA vaccine against SARS-CoV-2 developed by Pfizer-BioNTech, for children aged 5 to 11 years.

The Comirnaty booster dose had already been authorised for adults on 22 April 2022, and for adolescents aged 12 years and above on 24 February 2022 (see EUROPE 12899/26). (Original version in French by Émilie Vanderhulst)

Contents

Russian invasion of Ukraine
EUROPEAN PARLIAMENT PLENARY
SECTORAL POLICIES
EU RESPONSE TO COVID-19
SOCIAL AFFAIRS - EMPLOYMENT
EXTERNAL ACTION
ECONOMY - FINANCE - BUSINESS
BREACHES OF EU LAW
NEWS BRIEFS