ECDC and EMA update on COVID-19

4  August 2021 - Full vaccination is key to protecting against serious COVID-19, including disease caused by the Delta variant. ...

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Pfizer, Moderna raise prices of COVID-19 coronavirus vaccines for European Union

1 August 2021 - What’s the best way to get more people vaccinated against COVID-19 to try to end the ...

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Increased manufacturing capacity and supply for Spikevax

30 July 2021 - EMA's CHMP has approved a scale-up of the active substance production process at Moderna's COVID-19 vaccine ...

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EMA CHMP adopts positive opinion recommending authorisation for the use of the Moderna COVID-19 Vaccine in adolescents (12-17 years of age) in the European Union

23 July 2021 - . 23, 2021-- Moderna today announced that the EMA's CHMP adopted a positive opinion recommending marketing authorisation ...

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COVID-19 vaccine Spikevax approved for children aged 12 to 17 in EU

23 July 2021 - EMA’s CHMP has recommended granting an extension of indication for the COVID-19 vaccine Spikevax (previously COVID-19 Vaccine ...

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EMA starts rolling review of COVID-19 vaccine Vidprevtyn

20 July 2021 - EMA’s CHMP has started a rolling review of Vidprevtyn, a COVID-19 vaccine developed by Sanofi Pasteur. ...

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International regulators work towards alignment on development and authorisation of second generation COVID-19 vaccines

16 July 2021 - Regulatory convergence is critical for expediting and streamlining global development and authorisation of new or modified COVID-19 ...

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European efforts to assess Russia’s Sputnik V vaccine stymied by data gaps

13 July 2021 - The developers of Russia’s Sputnik V coronavirus vaccine have repeatedly failed to provide data that regulators ...

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EMA advises against use of COVID-19 vaccine Janssen in people with history of capillary leak syndrome

9 July 2021 - EMA’s safety committee has recommended that people who have previously had capillary leak syndrome must not be ...

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Comirnaty and Spikevax: possible link to very rare cases of myocarditis and pericarditis

9 July 2021 - EMA’s safety committee (PRAC) has concluded that myocarditis and pericarditis can occur in very rare cases ...

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Two additional manufacturing sites for BioNTech/Pfizer’s COVID-19 vaccine

22 June 2021 - EMA’s CHMP has approved additional manufacturing sites for the production of Comirnaty, the COVID-19 vaccine developed ...

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AstraZeneca welcomes court ruling on supply of its COVID-19 vaccine to Europe

18 June 2021 - AstraZeneca today welcomed the ruling by the Court of First Instance in Brussels. The European Commission had ...

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European regulator EMA says it won't set 50% efficacy threshold for COVID shots

18 June 2021 - The EMA said on Thursday it would not impose a 50% efficacy threshold for COVID-19 vaccines, ...

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Vaxzevria: EMA advises against use in people with history of capillary leak syndrome

11 June 2021 - EMA’s safety committee (PRAC) has concluded that people who have previously had capillary leak syndrome must not ...

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EMA raises awareness of clinical care recommendations to manage suspected thrombosis with thrombocytopenia syndrome

7 June 2021 - EMA’s COVID-19 taskforce (COVID-ETF) is advising health care professionals in the EU to consider recommendations by learned ...

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